Biosimilars

Many of the most expensive drugs on Earth are proteins grown from living cells — you can't just copy them like an ordinary pill. Biosimilars is the business of building a "near-identical version" to compete — and it's about to unlock more than $232 billion this decade.

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Biosimilars

Johnson & Johnson Targets Double-Digit Growth by End of Decade

Johnson & Johnson said it remains on track to grow through biosimilar competition for STELARA and expects its medicines, medical devices and pipeline to support accelerating growth through the end of the decade. Speaking at a Morgan Stanley event, Chief Executive Officer and Chairman Joaquin Duato said the company's current guidance calls for 6.5% adjusted operational sales growth and 7.3% adjusted earnings-per-share growth in 2026, with total revenue expected to exceed $100 billion for the first time. Duato said 2027 should be a better year than 2026 and that the company has line of sight to double-digit growth by the end of the decade, with more detail to come at an enterprise business review in early December. John Reed, executive vice president of Innovative Medicine and R&D, said Johnson & Johnson has 12 molecules that have achieved proof of concept and are in Phase III development, and that beyond DARZALEX it has 10 marketed medicines still early in their product life cycles. Capital allocation priorities center on launches such as ICOTYDE, INLEXZO, RYBREVANT, IMAAVY and the OTTAVA robotic surgical system, plus pipeline funding and earlier-stage business development, including the recent acquisitions of Halda Therapeutics and Firefly Bio and a collaboration with an option to acquire Sail. Duato said the company can reach double-digit growth this decade without acquisitions but views M&A as a way to reinforce growth into the following decade.
MarketBeat·4dRead more →
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Morgan Stanley Cuts Novo Nordisk to Underweight on Patent Cliff and Lilly Competition

Morgan Stanley downgraded Novo Nordisk to Underweight from Equal-weight while keeping a $40 price target, sending NVO shares down 2.1% on Friday. The bank argued the valuation does not fully reflect muted medium-term growth and the looming semaglutide patent cliff, with key protections for Ozempic, Rybelsus and Wegovy expiring around 2031 in Europe and 2032 in the United States. Semaglutide concentration is acute: adjusted sales of Wegovy injectable, Wegovy pill, Ozempic injection and the Ozempic pill/Rybelsus franchise totaled about DKK 112.2 billion in the first half of 2026, roughly 75.5% of total adjusted first-half sales. Eli Lilly's competitive pressure compounds the problem, as Mounjaro generated $18.6 billion in the first half, up 106%, and Zepbound generated $9.1 billion, up 60%, for a combined $27.7 billion, while Novo's first-half Ozempic sales declined 2% at CER and Wegovy product sales rose just 7% at CER. Lilly also launched oral Foundayo in the United States in April 2026, and smaller rivals Structure Therapeutics and Viking Therapeutics are advancing their own GLP-1 obesity therapies.
Zacks Investment Research·4dRead more →
Biosimilars

Teva Says Pivot to Growth Accelerating as Branded Drugs and Biosimilars Expand

Teva Pharmaceutical Industries said its "Pivot to Growth" strategy has entered its second phase, with management pointing to branded-medicine momentum, a stabilized generics business, an expanding biosimilars portfolio and a strengthened balance sheet. Speaking at a Morgan Stanley event, President and Chief Executive Officer Richard Francis said the strategy, launched in 2023, rests on four pillars: delivering on the growth engine, stepping up innovation, creating a generics powerhouse, and focusing the business and capital allocation. Francis said Teva has cut debt and secured investment-grade ratings from all three major agencies more than a year ahead of its projection, completed an oversubscribed refinancing in the prior week, and converted ADS shares into ordinary shares to broaden investor access. He reiterated confidence that AUSTEDO can eventually exceed $3 billion in sales, ahead of the prior $2.5 billion target, and said AJOVY is approaching the $1 billion threshold faster than expected, while UZEDY and long-acting olanzapine together represent a $1.5 billion to $2 billion opportunity. Teva has 11 biosimilars on the market and expects to add roughly nine more by the end of the decade, and Francis said the company is on track to exceed its $800 million biosimilars target for 2027 a year early. Chief Medical Officer Eric Hughes said the TL1A therapy duvakitug, developed with Sanofi for ulcerative colitis and Crohn's disease, showed the highest phase 2 results reported for the class, and that ecopipam, a first-in-class D1 antagonist for Tourette's disease, received priority review with a potential launch in the first half of 2027.
MarketBeat·4dRead more →
Biosimilars

Merck Bets on Tripled Pipeline and New Drugs to Offset 2028 Keytruda Patent Loss

Merck is relying on a growing pipeline and an expanding portfolio of newer medicines, including acquired assets, to offset the eventual loss of exclusivity for its blockbuster cancer drug Keytruda. Keytruda generated sales of $16.40 billion in the first half of 2026, up nearly 4.2% year over year, and is expected to remain strong until it loses patent exclusivity in 2028, after which biosimilars entering around 2028-2029 are likely to drive a sharp decline. Merck's phase III pipeline has almost tripled since 2021, and the company expects to launch 20 new drugs by 2030, with newer products already emerging as growth drivers: pulmonary arterial hypertension drug Winrevair and 21-valent pneumococcal conjugate vaccine Capvaxive generated $1.1 billion and $325 million, respectively, in first-half 2026 sales, while cancer drug Welireg sales surged 57% year over year to $470 million. Merck expects more than $70 billion of potential non-risk-adjusted commercial opportunity for the current pipeline by the mid-2030s, more than double the peak consensus sales estimate for Keytruda of $35 billion in 2028, and has stepped up acquisitions ahead of the patent expiry with deals for Verona Pharma, Cidara Therapeutics and Terns Pharmaceuticals. Management expects the Keytruda LOE period to look like a shallow dip with a fast return back to growth, even as Keytruda faces competition from Bristol Myers' Opdivo, Roche's Tecentriq and AstraZeneca's Imfinzi.
Zacks Investment Research·7dRead more →
Biosimilars

Sandoz unveils Bio100 strategy to lead biosimilars by 2040

Sandoz has unveiled an ambitious growth strategy, dubbed Bio100, aiming to become the undisputed leader in the biosimilar industry by 2040, with a portfolio of more than 100 biosimilars. Announced at its Capital Markets Day on 8 September, the plan targets a 'golden decade' for biosimilars, leveraging the industry's patent cliff. CEO Richard Saynor said the window of opportunity is wide open, and the company plans to more than double net sales over the next decade. Chief commercial officer Rebecca Guntern highlighted an 'unparalleled opportunity' from loss of exclusivity, with over $300bn in originator sales not yet targeted. Key growth drivers include GLP-1 receptor agonists, monoclonal antibodies, and antibody drug conjugates, with a $322m partnership with China's Henlius and a $300m investment in a new facility in Slovenia supporting the strategy.
Pharmaceutical Technology·9dRead more →
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FDA Approves BeOne Medicines' TEVIMBRA Combo for HER2-Positive Cancer

BeOne Medicines (NASDAQ:ONC) received FDA approval for TEVIMBRA in combination with ZIIHERA and chemotherapy as a first-line treatment for HER2-positive gastroesophageal adenocarcinoma, a cancer affecting over 31,000 Americans annually. The approval is based on Phase 3 data showing a median overall survival of 26.4 months, the longest reported for an immunotherapy-based regimen in this setting. The company also reported second-quarter revenue of $1.7 billion, up 30% year over year, and raised its full-year revenue guidance to $6.6–$6.8 billion. However, the CELESTIAL 301 trial failed to show statistical superiority on its primary endpoint, and the company faces biosimilar competition for XGEVA. Shares trade at a forward P/E of 46.73, reflecting high growth expectations.
Insider Monkey·17dRead more →
Biosimilarsimpact 4

Trump Adds 9 Mid-Sized Drugmakers to MFN Pricing Deals

President Trump announced on Monday that his administration has signed separate drug-pricing agreements with nine mid-sized pharmaceutical companies, expanding his Most-Favored-Nation (MFN) pricing push beyond Big Pharma. The companies include Alcon, Astellas Pharma, BeOne Medicines, BridgeBio Pharma, CSL, Kyowa Kirin, Sun Pharma, Teva Pharmaceuticals, and UCB, which have agreed to reduce prescription drug prices to match those in comparable developed countries. In return, they receive a reprieve from import tariffs on pharmaceutical ingredients, contingent on expanding domestic manufacturing, with a collective commitment of at least $19.6 billion in U.S. manufacturing. Some companies also agreed to contribute active pharmaceutical ingredients to a government stockpile reserve, such as Teva supplying 45 metric tons of metronidazole and UCB providing 163 tons of levetiracetam. With these additions, the total number of drugmakers with MFN agreements has risen to 26, covering 89% of the branded drug market, and the administration has called on Congress to codify the policy through the Great Healthcare Plan.
Zacks Investment Research·17dRead more →
Biosimilars4

Trump unveils drug-pricing deals with CSL, Astellas, and other biotechs

President Donald Trump introduced a new set of drug-pricing deals with global pharmaceutical companies and smaller biotechs on Monday, advancing efforts to cut healthcare costs for American consumers. Deals were signed with Astellas, BeOne Medicines, CSL, BridgeBio, Sun Pharmaceutical, and UCB SA, Trump said in an Oval Office event with executives, according to Reuters. These companies have offered drugs to state Medicaid programs at most-favored-nation prices, which Trump described as a tremendous discount that should bring down medical costs. Israel's Teva, which also attended, said it is still in discussions with the administration on a potential agreement. The number of drugs covered and the discounts remain unclear, as the White House did not release details and some companies described terms as private. The deals follow earlier agreements with 17 of the world's largest drugmakers, including Pfizer, Eli Lilly, and Novo Nordisk, which agreed to cut prices for federal health programs and sell some medicines directly to patients through a Trump-branded website in return for tariff relief.
Seeking Alpha·18dRead more →
Biosimilars

Jianyou Subsidiary's Adalimumab Injection Gains US FDA Approval for Additional Manufacturing Site

Jianyou Co., Ltd. announced that its subsidiary Emerge recently received approval from the US FDA for an additional manufacturing site for its adalimumab injection, permitting production at the Nanjing Jianyou Biochemical Pharmaceutical Co., Ltd. facility. The injection is indicated for rheumatoid arthritis, polyarticular juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn's disease, ulcerative colitis, chronic plaque psoriasis, hidradenitis suppurativa, and non-infectious uveitis.
Jiemian·18dRead more →
Biosimilars

Teva and Trump Administration Agree to Lower Medicaid Drug Prices

Teva Pharmaceuticals and the Trump Administration have announced a shared commitment to lower the cost of select medicines for U.S. Medicaid patients, with a final agreement expected to support continued investment in innovation and manufacturing. The deal, if finalized, would align U.S. Medicaid pricing for certain drugs with leading developed markets through the GENEROUS framework, and include a Most-Favored-Nation commitment for future innovative launches. Teva has also offered a reserve of active pharmaceutical ingredients for public health needs and pledged further investment in U.S. manufacturing. Negotiations remain confidential, and the agreement is part of the administration's broader drug pricing priorities.
GlobeNewswire·18dRead more →
Biosimilars2

Alvotech's AVT80 BLA Accepted by FDA for Subcutaneous Entyvio Biosimilar

Alvotech announced that the U.S. Food and Drug Administration has accepted for review its Biologics License Application for AVT80, a proposed interchangeable biosimilar to Entyvio (vedolizumab) for subcutaneous administration via prefilled syringe and autoinjector. This acceptance follows the May acceptance of Alvotech's BLA for AVT16, the intravenous presentation, meaning the company's vedolizumab biosimilar program now covers both intravenous and subcutaneous forms. Under a partnership with Teva Pharmaceutical Industries, Alvotech handles development and manufacturing while Teva manages commercialization. The BLA is supported by analytical, pharmacokinetic, and immunogenicity data, and a pivotal pharmacokinetic study met all primary endpoints in February 2026. If approved, AVT80 would expand biosimilar options for patients with ulcerative colitis and Crohn's disease in the United States.
Yahoo Finance·18dRead more →
Biosimilars

Shanghai Pharmaceuticals Receives Production Approval for Ruxolitinib Phosphate Tablets

Shanghai Pharmaceuticals announced that its subsidiary Changzhou Pharmaceutical Factory has received a drug registration certificate for Ruxolitinib Phosphate Tablets from the National Medical Products Administration, with specifications of 5 mg, 15 mg, and 20 mg, classified as a Category 4 chemical drug. The drug is used to treat adult patients with intermediate or high-risk primary myelofibrosis and other myelofibrosis conditions, as well as graft-versus-host disease in patients aged 12 and older. It was jointly developed by Incyte and Novartis and launched in the United States in 2011. Changzhou Pharmaceutical Factory submitted its registration and marketing application in December 2024, with cumulative research and development investment of approximately 24.81 million yuan.
Jiemian·19dRead more →
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Mabwell Biotech's H1 revenue up 209%, loss narrows to 522 million yuan

Mabwell Biotech released its 2026 interim report, with first-half operating revenue of 313 million yuan, up 209.04% year on year. Net loss attributable to the parent company was 522 million yuan, narrowing from a loss of 551 million yuan in the same period last year. Second-quarter revenue was 185 million yuan, up 228.2% year on year, but net loss attributable to the parent company was 280 million yuan, widening from a loss of 260 million yuan a year earlier. As of the end of the second quarter, the company's total assets were 5.295 billion yuan, up 16.2% from the end of the previous year, and net assets attributable to the parent company were 873 million yuan, up 149.9%. The company maintained a high level of research and development spending, with R&D investment of 431 million yuan during the reporting period, up 10.03% year on year. It currently has 15 key products in clinical research or on the market, including 11 innovative drugs and 4 biosimilars. The company flagged risks including continued large-scale R&D investment, drug approval, and centralized procurement of biologics.
财中社·20dRead more →
Biosimilars

Alvotech Rises 11.7% on Expanded Lotus Biosimilar Deal

Alvotech's stock climbed 11.7% after the company announced an expanded licensing and commercialization agreement with Lotus Pharmaceutical for biosimilar candidates AVT34 (Imfinzi) and AVT87 (Hemlibra) across the United States and eight Asian markets, with potential consideration of up to approximately US$150 million plus ongoing supply revenues. This deal, announced in August 2026, broadens Alvotech's access to oncology and hematology markets while keeping it in control of development, regulatory approvals, and global product supply. The expansion could modestly support near-term milestones, but the key short-term catalyst remains timely FDA and EMA decisions on late-stage assets. Alvotech's 2026 revenue guidance of US$650 million to US$700 million already relies heavily on product and milestone flows, so any payments from Lotus would sit inside that ambitious framework. The company's recent swing back to a net loss in the first half of 2026 underscores its dependence on approval timing and partner ramp-up.
Simply Wall St·20dRead more →
Biosimilars

Henlius CEO Zhu Jun: Biosimilar Volume-Based Procurement May Be an Opportunity, Not a Challenge

Henlius Executive Director and CEO Zhu Jun said at the interim results briefing on August 24 that volume-based procurement of biosimilars may not be a challenge but could be an opportunity. In the first half of this year, Henlius achieved revenue of 3.588 billion yuan, up 27.3 percent year on year, and net profit of 430 million yuan, up 10.3 percent year on year. The company already has 10 products approved for marketing in more than 60 countries and regions worldwide. In the first half of 2026, global product sales revenue reached 2.9386 billion yuan, up 14.9 percent year on year, of which overseas product sales revenue surged 159.4 percent year on year to 105.3 million yuan. Zhu Jun said the company began actively preparing for biosimilar volume-based procurement several years ago, on the one hand continuously optimizing production processes to reduce manufacturing costs, and on the other hand seeking new sales growth, including stepping up innovative drugs and accelerating overseas expansion.
第一财经·26dRead more →
Biosimilars

Alvotech and Lotus Pharmaceutical sign biosimilar licensing deal

Alvotech announced a strategic licensing and commercialization agreement with Lotus Pharmaceutical covering two biosimilar candidates in the United States and selected Asian markets. The deal covers AVT34, a proposed biosimilar to Imfinzi, and AVT87, a proposed biosimilar to Hemlibra. Under a semi-exclusive U.S. agreement, Alvotech retains the right to commercialize both products directly alongside Lotus, while Lotus will commercialize through its U.S. subsidiary Alvogen. In Asia, Lotus gets exclusive rights in eight markets: South Korea, Taiwan, Thailand, Vietnam, the Philippines, Singapore, Hong Kong and Malaysia. The agreement has a potential value to Alvotech of up to approximately $150 million in upfront and milestone payments, plus ongoing supply revenues.
Alvotech·28dRead more →
Biosimilars2

Aoxiang Pharmaceutical's Wholly-Owned Subsidiary Receives Drug Registration Certificate for Ruxolitinib Phosphate Tablets

Aoxiang Pharmaceutical announced that its wholly-owned subsidiary Qizheng Pharmaceutical has received the Drug Registration Certificate for Ruxolitinib Phosphate Tablets issued by the National Medical Products Administration. The drug is indicated for the treatment of intermediate or high-risk primary myelofibrosis, among other indications. This approval is deemed equivalent to passing the generic drug consistency evaluation, which will have a positive impact on the company's future development.
Biosimilars

Bio-Thera Solutions' Bevacizumab Injection Approved for Additional Hepatocellular Carcinoma Indication

Bio-Thera Solutions announced that the company recently received a drug supplementary application approval notice from China's NMPA for its bevacizumab injection Pubeixi. The drug has been approved for an additional indication, hepatocellular carcinoma. With this approval, Pubeixi has now been approved for six indications in China. Commercial licensing partnerships for the drug now cover 104 countries and regions worldwide.
Biosimilars

Fuji Pharma obtains approval for generic drug Pomalidomide Capsules

Fuji Pharma announced on the 17th that it has obtained manufacturing and marketing approval for the anti-hematologic malignancy agent Pomalidomide Capsules 1 mg, 2 mg, 3 mg, and 4 mg F. The originator product is Pomalyst Capsules, indicated for relapsed or refractory multiple myeloma. Pomalidomide Capsules is the first generic version to receive approval, and the number of market entrants, including Fuji Pharma, will be two companies. The company already markets Filgrastim BS Injection Syringe F and Lenalidomide Capsules F in the hematology field, and aims to expand its hematology product lineup with this approval.
フィスコ·31dRead more →
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Sandoz and Henlius sign $322m biosimilar collaboration deal

Sandoz has entered a collaboration agreement with Shanghai Henlius Biotech to develop up to 10 biosimilars, with total milestone payments of up to $322 million. The deal includes near-term payments of up to $100.5 million for initial assets, and Henlius will develop and manufacture the products while Sandoz handles commercialization worldwide except China. The initial assets include biosimilars referencing Erbitux, Repatha, and Benlysta, as well as a recombinant human hyaluronidase in technical development. Sandoz's biosimilar pipeline now stands at 39 assets, with potential to reach 46, and the company says the agreement supports its strategy to capture a significant share of the biosimilar loss-of-exclusivity market over the next decade.
Pharmaceutical Technology·32dRead more →
Biosimilars

Generic Drugs Market to Reach $571.12 Billion by 2031

The global generic drugs market is projected to grow from $419.37 billion in 2025 to $571.12 billion by 2031, a compound annual growth rate of 5.11%. Patent expirations between 2026 and 2028 are expected to open approximately $40 billion in annual branded revenue to generic manufacturers, with key products including sitagliptin, apixaban, dabigatran and ticagrelor. Biosimilars are forecast to expand at a 6.89% CAGR, and eight adalimumab biosimilars have already captured about 45% of Humira's U.S. volume. Cardiovascular drugs accounted for 56.73% of market revenue in 2025, while oncology is projected to be the fastest-growing therapeutic area at a 7.34% CAGR. North America held 42.76% of global revenue in 2025, and Asia-Pacific is expected to register the fastest regional growth at 7.89% through 2031.
GlobeNewswire·39dRead more →
Biosimilars

Kyungdong Pharmaceutical and Asimov complete cell line development for biosimilar antibody

Kyungdong Pharmaceutical and Asimov have completed a cell line development campaign for a biosimilar antibody candidate. Kyungdong secured a high-performing production cell line using Asimov's CHO Edge System, which combines a GS knock-out CHO host, a hyperactive transposase, a genetic parts library, and the AI-driven genetic design software Kernel. The resulting cell line achieved a high titer, supporting downstream process development and future commercialization. Kyungdong CEO Ryu Gi-sung expressed satisfaction with the collaboration as the company expands its biopharmaceutical business.
GlobeNewswire·40dRead more →
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AbbVie raises full-year revenue guidance to $67.6 billion after strong Q2

AbbVie reported second-quarter 2026 total revenue of nearly $17 billion, reflecting 10.2% growth driven by its immunology and neuroscience portfolios, and raised its full-year revenue guidance by $300 million to approximately $67.6 billion. Adjusted earnings per share came in at $3.65, exceeding the guidance midpoint by $0.06 despite a $0.17 unfavorable impact from acquired IPR&D expense. SKYRIZI sales reached $5.5 billion, up 24% operationally, while RINVOQ sales surpassed $2.5 billion, a 23.7% operational increase. The company also announced the planned acquisition of Apogee Therapeutics, which is expected to contribute $0.14 of dilution to the 2026 adjusted EPS outlook.
The Motley Fool·46dRead more →
Biosimilars

Polpharma Biologics' Vedolizumab Biosimilar PB016 Accepted for Review by FDA and EMA

Polpharma Biologics International AG announced that the U.S. Food and Drug Administration and the European Medicines Agency have accepted for review the Biologics License Application and Marketing Authorisation Application, respectively, for PB016, a proposed vedolizumab biosimilar candidate to Takeda's Entyvio. The applications cover a lyophilized vial for intravenous administration for adults with moderately to severely active ulcerative colitis and Crohn's disease. PB016 was developed and will be manufactured by Polpharma Biologics, with Fresenius Kabi holding exclusive global commercialization rights outside the Middle East and North Africa pending regulatory approvals. The biosimilar development program included a Phase 1 trial in healthy volunteers and a Phase 3 trial in ulcerative colitis patients. Inflammatory bowel disease affects approximately 2.4 million patients in the US and 2.5 to 3 million in Europe.
Business Wire·49dRead more →
Biosimilars

SciSparc, Avantor, NeoGenomics Lead Biotech Gains on Milestones and Upgraded Outlooks

Several biotech stocks posted sharp gains on Wednesday, led by SciSparc after its subsidiary completed internal validation of a quantum sampling platform for clinical trial data. SciSparc closed at $9.09, up 70.54%, following the announcement that NeuroThera Labs successfully validated the platform being advanced by CliniQuantum, in which NeuroThera holds a 54.01% ownership interest. Avantor rose 15.78% to $14.38 after reporting second-quarter net sales of $1.69 billion and raising its full-year adjusted EPS guidance to $0.80 to $0.83 from $0.77 to $0.83. NeoGenomics gained 13.96% to $15.27 after second-quarter consolidated revenue increased 11% to $202 million and the company lifted its full-year revenue outlook to $802 million to $806 million from $797 million to $803 million. Alvotech climbed 13.87% to $3.53 after the FDA classified the inspection of its Reykjavik manufacturing facility as Voluntary Action Indicated, a step forward for its biosimilar applications. Sanara MedTech surged 13.55% to $30.25 after agreeing to be acquired by MiMedx Group in a cash-and-stock deal valued at $35 per share, or about $350 million in total enterprise value. LB Pharmaceuticals advanced 11.62% to $39.00 after securing a $150 million private placement and accelerating the timeline for topline results from its Phase 3 schizophrenia trial to the first half of 2027.
RTTNews·51dRead more →
Biosimilars2

Sandoz Wins Brazil Approval for New Semaglutide Diabetes Drug

Sandoz Group AG has received marketing authorization from Brazil's health regulator ANVISA for Owozy, a new semaglutide treatment for type-2 diabetes. The approval enables a launch in the second half of 2026, with the drug to be available in a pre-filled multi-dose disposable pen. Owozy was developed by Adalvo and is commercialized in Brazil by Sandoz, entering a market estimated at USD 1.8 billion. Sandoz stated the approval has no impact on its 2026 financial guidance, with commercial contribution expected after the launch later this year.
RTTNews·51dRead more →
Biosimilars

Alvotech Stock Rises After FDA Closes Reykjavik Facility Inspection

Alvotech announced that the U.S. FDA has successfully closed its inspection of the company's manufacturing facility in Reykjavik, Iceland, conducted in May 2026. The FDA classified the site as Voluntary Action Indicated, signaling that any observations identified during the inspection have been adequately addressed. CEO Lisa Graver said the closure reflects the company's ongoing commitment to strengthening its quality systems and manufacturing operations, adding that Alvotech continues to work with the FDA to advance recent Biologics License Applications toward approval. The company recently resubmitted BLAs for AVT05, a biosimilar to Simponi, and AVT06, a biosimilar to Eylea, and the FDA accepted the submission of AVT16, a proposed biosimilar to Entyvio, in June 2026. Alvotech has five biosimilars already approved and marketed globally, with a pipeline of 13 disclosed candidates. The stock is currently trading at $3.53, up 13.87 percent.
RTTNews·51dRead more →
Biosimilars5

Bio-Thera Solutions expects first-half 2026 loss to widen to between 230 million and 290 million yuan

Bio-Thera Solutions issued an announcement, projecting a net loss attributable to the parent company of between 230 million and 290 million yuan for the first half of 2026, an increase in loss of 105 million to 165 million yuan compared with the same period last year. After deducting non-recurring items, the net loss attributable to the parent is expected to be between 240 million and 300 million yuan, a year-on-year increase in loss of 68.8 million to 129 million yuan. The change in performance is mainly due to steady growth in sales of adalimumab injection and tocilizumab injection, with operating revenue rising by 60 million to 90 million yuan year-on-year, an increase of 13.58% to 20.37%, but research and development expenses are expected to increase by 100 million to 140 million yuan, a year-on-year rise of 28.67% to 40.14%, leading to a wider loss. In the first quarter of 2026, the company achieved revenue of 252 million yuan and a net loss attributable to the parent of 152 million yuan.
财中社·53dRead more →
Biosimilars2

Teva's duvakitug could drive another 50% surge as turnaround gains momentum

Teva Pharmaceutical Industries' shift from generic to branded drugs has driven an 85% share price surge over the past 12 months, and its pipeline candidate duvakitug could fuel another 50% rally. Branded drugs like Austedo, Ajovy, and Uzedy are growing sales at mid-double-digit rates, while generics now account for just over half of total revenue. Management expects 2026 earnings per share between $1.91 and $2.11, down from $2.65 in 2025 due to the dilutive impact of the Emalex Biosciences acquisition, but forecasts a 30% increase in operating profit and adjusted EBITDA starting next year. Duvakitug, co-developed with Sanofi for ulcerative colitis and Crohn's disease, is entering phase 3 trials after promising phase 2b results, with peak annual sales projected at $2 billion to $5 billion. With the stock trading at less than 10 times estimated 2027 earnings, further progress on duvakitug could trigger another major rally.
The Motley Fool·54dRead more →
Biosimilars2

Wall Street Analysts See Over 60% Upside for Teva as It Shifts to Branded Drugs

Wall Street analysts are unanimously bullish on Teva Pharmaceutical Industries, with price targets implying up to 60% upside from its current share price. Every analyst polled by CNN Business rates the stock a buy, and the median 12-month price target is $40. Teva is pivoting from low-margin generics toward higher-margin branded drugs, with top-seller Austedo growing 41% to $559 million in the first quarter of 2026. Management expects operating margins to reach 30% by 2027, up from 12.5% last year, as branded and biosimilar sales expand. The company recently acquired Emalex Biosciences for $700 million and filed a New Drug Application for ecopipam, a Tourette's syndrome treatment, following positive Phase 3 data.
The Motley Fool·54dRead more →
Biosimilars

J&J's Innovative Medicine unit posts 6.8% operational sales growth in Q2

Johnson & Johnson's Innovative Medicine segment delivered a 6.8% operational sales increase to $16.38 billion in the second quarter, driven by strong performances from Darzalex, Tremfya, and Erleada. Darzalex sales rose 18.9% to $4.21 billion, Tremfya surged 72.5% to $2.05 billion, and Erleada grew 9.5% to $995 million. These gains were partly offset by a 55.2% drop in Stelara sales to $740 million due to loss of exclusivity, which negatively impacted segment growth by 760 basis points. J&J expects the Innovative Medicine segment to remain its primary growth engine through the remainder of 2026, supported by new launches like Icotyde, Rybrevant, and Inlexzo, though generic competition for Simponi and Opsumit is anticipated to begin this year.
Zacks Investment Research·56dRead more →
Biosimilars

Roche Cuts Expected Generic Sales Hit to $736 Million, Shares Jump 3.2%

Roche Holding AG has reduced its estimate of revenue lost to generic competition this year to about 600 million Swiss francs, or $736 million, down from a previous forecast of 1 billion francs. The Swiss drugmaker also reported better-than-expected first-half earnings, though quarterly revenue matched analyst estimates and full-year guidance was unchanged. Chief Executive Officer Thomas Schinecker said the company was moving toward the upper end of its guidance but remained cautious about third-quarter performance. Roche shares rose as much as 3.2% in Zurich as investors weighed the lower generic impact against mixed product-level results, with blockbuster eye medicine Vabysmo showing weaker U.S. performance. The company is relying on new drugs and acquisitions to offset about 5.8 billion francs in revenue expected to be lost to copycat medicines by 2029, with experimental breast-cancer pill giredestrant seen as a key asset that Citi analysts estimate could generate $14.5 billion in annual peak sales.
GuruFocus·57dRead more →
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Trump announces 100% tariff on generic drug imports starting 2028

President Donald Trump announced that the United States will begin imposing a 100% tariff on generic drug imports starting in 2028, after a further two-year exemption, and said the tariff rate will rise to 200% in the next phase. The measure aims to bring generic drug manufacturing back to the US, with companies that fail to invest in building plants within the specified timeframe facing tax penalties. Trump also announced tariff exemptions for companies that invest in building drug manufacturing facilities in the US, and drug companies can receive tariff exemptions if they accept the most-favoured-nation policy, which requires charging US buyers the same price as charged to other countries. Earlier this year, Trump signed a proclamation imposing a 100% tariff on patented drugs and has also pushed for tariffs on other pharmaceutical products during his term.
InfoQuest·59dRead more →
Biosimilars

Sci-Tech Innovation Board Healthcare ETF Huaxia Hits 383 Million Yuan, a Near One-Year High

The Sci-Tech Innovation Board Healthcare ETF Huaxia has reached a latest scale of 383 million yuan, a near one-year high. As of 11:26 AM on July 22, 2026, the ETF was quoted at 1.05 yuan, with intraday turnover of 9.43 percent and trading volume of 36.5426 million yuan. The Shanghai Sci-Tech Innovation Board Biomedical Index it tracks rose 0.12 percent. In news, US President Trump announced zero tariffs on imported generic drugs for two years starting August 1, 2026, after which tariffs will gradually increase to 200 percent. Meanwhile, the National Essential Medicines List 2026 Edition included 16 innovative drugs in bulk for the first time, accelerating the penetration of innovative drugs into primary care markets. Great Wall Guorui Securities noted that total innovative drug business development deal value reached 110 billion US dollars in the first half of 2026, with collaboration models upgrading toward mature assets and technology platforms.
Jiemian·59dRead more →
Biosimilars2

Biotech IPOs Surge 55% as AI Listings Lose Momentum

Biotechnology and pharmaceutical IPOs have generated a weighted average return of 55% in the U.S. market this year, sharply outperforming the broader market's 4.4% weighted average loss, according to Bloomberg data through July 17. The strong performance is drawing more drug developers to go public, with at least six filing this month, led by Scribe Therapeutics, and the number of completed biotech IPOs in 2026 already surpassing last year's total while proceeds exceed $5 billion, roughly three times the prior year's amount. Parabilis Medicines raised $770.6 million in the largest biotech IPO on record, and Veradermics has gained more than 500% since its February debut, making it the best-performing U.S. IPO across all sectors. The sector's recovery is supported by a 13% gain in the Nasdaq Biotechnology Index, a stable regulatory environment, and renewed acquisition activity, including three deals valued at $10 billion or more announced in the past month involving AbbVie, GSK, and Vertex Pharmaceuticals. Investment bankers note that major fund groups are reallocating capital toward healthcare, though higher interest rates could pose a headwind.
GuruFocus·59dRead more →
Biosimilars7

Novartis returns to sales growth in Q2 as newer medicines offset generic pressure

Novartis reported higher second-quarter sales, returning to growth as strong demand for newer medicines offset the continued impact of generic competition. Net sales reached $14.41 billion, increasing 3% in US dollars and 1% at constant exchange rates, with volume growth contributing 18 percentage points while generic competition reduced sales by 14 percentage points. Sales of Kisqali rose 43% at constant currencies to $1.70 billion, Kesimpta climbed 32% to $1.42 billion, Scemblix generated $562 million after rising 89%, Pluvicto advanced 43% to $651 million, and Leqvio recorded 59% growth to $480 million, helping to compensate for declines in older medicines such as Entresto, which dropped 51% to $1.18 billion. Net income fell 19% to $3.26 billion, while core operating income remained unchanged at $5.94 billion. The company reaffirmed its full-year 2026 outlook, forecasting low single-digit growth in net sales and a low single-digit decline in core operating income at constant exchange rates.
Yahoo Finance·59dRead more →
Biosimilars

Roche Holding Could Be 7% Undervalued on Pipeline Momentum

Roche Holding could be 7% undervalued relative to a narrative fair value of CHF353.34, according to an analysis by Simply Wall St. The current share price of CHF330.2 reflects a 5.33% return over the past 90 days and a 32.83% total shareholder return over one year, driven by pipeline momentum including the US FDA granting Priority Review to a supplemental Biologics License Application for Gazyva/Gazyvaro in primary membranous nephropathy. The fair value estimate is based on Roche's strong fundamentals, including $80 billion in revenue, approximately $26 billion in EBITDA, and margins around 30%, along with a defensive profile and a dividend yield of about 3%. However, the valuation remains sensitive to late-stage pipeline delivery and biosimilar pressure.
Simply Wall St·64dRead more →
Biosimilars

Pfizer's Oncology Growth Story in Focus Ahead of Q2 Results

Pfizer's oncology segment, which accounts for about 27% of total revenues, is expected to show continued growth when the company reports second-quarter results on August 4. Oncology revenues rose 7% to $3.8 billion in the first quarter of 2026, driven by key drugs like Padcev, Lorbrena, and the Braftovi-Mektovi combination, which are likely to offset declining sales of Ibrance and Adcetris. The Zacks Consensus Estimate for Padcev is $661 million, while that for Ibrance is $1.05 billion. Pfizer's six oncology biosimilars are also expected to have made a significant contribution to sales growth in the quarter. On the pipeline front, several late-stage candidates such as atirmociclib and sigvotatug vedotin are advancing, and a regulatory application for sasanlimab is under review in the EU. Additionally, Pfizer plans to start four pivotal studies in 2026 for PF-08634404, a dual PD-1 and VEGF inhibitor in-licensed from China's 3SBio, with an update expected on the second-quarter conference call.
Zacks Investment Research·66dRead more →
Biosimilarsimpact 4

Germany passes healthcare cost reform despite strong pharma opposition

Germany's Bundestag has approved a major financial reform of the statutory health insurance system, aiming to cut costs by over €16 billion and prevent premium increases. The law raises mandatory rebates from pharmaceutical companies, limits hospital costs passed to insurers, adjusts reimbursement rates, and ties future spending growth to overall economic growth. The vote was 318 in favor and 284 against, reflecting deep controversy over which sector should bear the financial burden. Industry leaders, including Eli Lilly, Boehringer Ingelheim, Pfizer, and Merck KGaA, have warned the measures will harm investment and innovation, with Lilly's CEO stating the company will scale back manufacturing plans in Germany. The reform, a flagship agenda of Chancellor Friedrich Merz, comes as the US Trade Representative investigates Germany's drug pricing policies for alleged underpayment and discrimination against US commerce.
Pharmaceutical Technology·67dRead more →
Biosimilars

Bevacizumab Biosimilars Market to Reach USD 5.94 Billion by 2035

The global bevacizumab biosimilars market is projected to grow from USD 2.18 billion in 2025 to USD 5.94 billion by 2035, at a compound annual growth rate of 10.54 percent, according to a new report by SNS Insider. North America held the largest share in 2025 at 41.52 percent of revenue, while Asia-Pacific is the fastest-growing region with a CAGR of around 13.28 percent. Among products, Mvasi led with a 28.46 percent revenue share in 2025, and Zirabev is expected to register the fastest CAGR through 2035. Colorectal cancer was the dominant application segment with a 37.85 percent share, and hospital pharmacies accounted for 63.74 percent of distribution. Key players include Amgen, Pfizer, Mylan, Samsung Bioepis, and Celltrion Healthcare.
GlobeNewswire·70dRead more →