Merck Faces Keytruda Biosimilar Threat Ahead of 2028 Patent Expiry

Regulation
โดย GuruFocus·US·Read original
Summary · why it matters

Merck received a warning on Thursday as Cipla's U.S. subsidiary secured exclusive American commercialization rights to Qilu Pharmaceutical's proposed pembrolizumab biosimilar, QL2107, ahead of Keytruda's expected 2028 core patent expiration. The biosimilar is not an immediate threat, as Qilu must still complete development, win regulatory approval, and prove manufacturing capability, with Cipla taking over only if QL2107 reaches the U.S. market. Merck's Keytruda franchise, which posted $8.4 billion in quarterly sales including $463 million from the newer subcutaneous version Qlex, faces increasing competition from lower-priced alternatives. Qlex already contributes about 5.5% of franchise revenue and is a key part of Merck's patent-cliff defense. Merck's stock trades at $151.07, 25.87% above its GF Value of $120.02, raising the stakes for the company to transition patients to Qlex and build its next growth engine before biosimilars arrive.

Impact on stocks 3

Biotech & Genomic Medicine▼ · 1 stocks
Merck & Company Inc
MRK
▼ NegativeCompetitionrelevance

Cipla's US unit secured exclusive US commercialization rights to Qilu's proposed pembrolizumab biosimilar, threatening Merck's Keytruda franchise ahead of its 2028 patent expiry.

Critical Materials & Supply Chain▲ · 1 stocks
Defense & Geopolitical Fragmentation▲ · 1 stocks

Off-coverage companies 2

CiplaPrivate▲ Positive
Demandrelevance

Cipla's US subsidiary secured exclusive American commercialization rights to Qilu's pembrolizumab biosimilar QL2107.

Qilu Pharmaceutical Co., Ltd.Private▲ Positive
Demandrelevance

Qilu Pharmaceutical's proposed pembrolizumab biosimilar QL2107 gained a US commercialization partner in Cipla, advancing its path to the US market.

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