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FDA Approves Eli Lilly’s REZVOGLAR As the Second Interchangeable Insulin Glargine

On November 16, FDA approved Eli Lilly’s REZVOGLAR (insulin glargine-aglr) as the second interchangeable biosimilar to LANTUS (insulin glargine), joining SEMGLEE (insulin glargine-yfgn), which was previously approved as interchangeable to LANTUS.  Regarding REZVOGLAR’s approval as interchangeable, FDA stated: “This approval furthers FDA’s longstanding commitment to support a competitive marketplace for…

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Biosimilars Licensing Agreement Updates

Earlier this week, Biocon Biologics Ltd. announced that it has entered into a strategic out-licensing agreement with Yoshindo Inc. to commercialize ustekinumab and denosumab biosimilars for the Japanese market.  Pursuant to the agreement, Yoshindo gets exclusive commercialization rights for the biosimilars in Japan, with an estimated market opportunity of $700…

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AbbVie Inc. et al. v. Alvotech hf. Updates

We have previously reported on AbbVie’s first and second wave suits against Alvotech hf. (Alvotech) in the Northern District of Illinois regarding an adalimumab biosimilar.  In the second wave suit, on December 21, 2021, AbbVie filed a Second Amended Complaint.  On December 29, Alvotech filed a Renewed Motion to Dismiss…

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