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

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.

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.

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.