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Alvotech Sees Opportunities Open Up With US Approvals

Executives Discuss Humira And Stelara Rivals, Interchangeability, Partnerships And Pipeline

 
• By Dave Wallace

With long-awaited US approvals now rolling in and a growing pipeline of future biosimilars, further opportunities are opening up for Alvotech – including potentially launching a second interchangeable Stelara biosimilar in the US just a few months after market formation – chief commercial officer Anil Okay and chief strategy officer Ming Li tell Generics Bulletin.

US flag on globe pointing towards opportunity
US Opportunities Are Opening Up For Alvotech • Source: Shutterstock

Speaking to Alvotech chief commercial officer Anil Okay and chief strategy officer Ming Li, the significance to the biosimilars developer of its recent successful US Food and Drug Administration inspection and subsequent approval for a US Humira (adalimumab) biosimilar are immediately apparent.

With Alvotech having previously been knocked back by the FDA on adalimumab due to issues with its biosimilar production plant in Reykjavik, a green light from the agency for the facility in early 2024 paved the way for a February approval of not only its Simlandi (adalimumab-ryvk) biosimilar (see sidebar) but also a pending rival to Stelara (ustekinumab), for which FDA approval is expected in April

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