Sandoz Defeat On Amgen’s Otezla Pushes US Generic Opportunity Back To 2028
Zydus Cadila Also On Receiving End Of Unfavorable Ruling
Amgen is set to enjoy its monopoly on the Otezla oral treatment for plaque psoriasis until late into the decade, after ANDA sponsors Sandoz and Zydus Cadila failed to find a way around the originator’s intellectual property, including a key patent expiring early in 2028.
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Amgen sees opportunity to grow Otezla sales through new indications and additional ex-US launches. The deal depends on Bristol closing its Celgene acquisition, pending FTC clearance.
Sandoz’ partnership with China’s Gan & Lee covering three biosimilar insulin products continues to make progress, with the conclusion of a pair of Phase III trials involving a proposed biosimilar to Lantus (insulin glargine).
Japan’s Sawai was cautioned by one analyst earlier this year that it lacked sufficient excess production capacity to handle the sharp expansion in demand for its products. Now the company has announced plans to build a new solid dosage form facility.