In the world of small-molecule generics, firms that move from developing off-patent medicines towards focusing on innovative drugs are sometimes described as “poacher turned gamekeeper,” reflecting the change in mindset that comes when moving from a position of targeting brands to defending them.
Amgen Calls For Balance To Support Biosimilars
US Firm Urges Science-Based Education And Policies That Facilitate Competition
A balanced policy environment that supports competition is needed to allow biosimilars to flourish in the US, according to Amgen, along with strong and transparent IP processes to underpin continuing innovation in the biologics space. Chad Pettit, the firm’s executive director of marketing and global biosimilars commercial lead, talks to Generics Bulletin about the firm’s “unique perspective” on biosimilars.
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Organon has swelled its immunology biosimilar portfolio after acquiring the US commercial rights to Bio-Thera’s tocilizumab biosimilar from Biogen, which last year decided to retain its interests in biosimilars following a lengthy strategic review.
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Alvotech has named two new key executives, while Biosimilars Canada has elected its 2025 leaders and the AAM has welcomed the new FDA commissioner in the US.
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Accord received positive opinions for its Prolia and Xgeva biosimilars at the latest meeting of the EMA’s CHMP. Meanwhile, Celltrion picked up a nod for another Stelara biosimilar, while Rechon Life Science withdrew an application for human insulin.
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The US FDA has deemed certain CRO Raptim Research’s in vitro bioequivalence studies as “not acceptable” and raised concerns over its in vivo study methods. Will other agencies follow suit?
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Teva should not be able to overturn European fines imposed over a historical “pay-for-delay” arrangement covering Cephalon’s Provigil (modafinil), an advocate general of the CJEU has recommended.