April Breyer Menon, Author at Venable's BiologicsHQ

Biocon Launches Denosumab Biosimilars Bosaya™ / Aukelso™ in the United States

by April Breyer Menon | Apr 9, 2026

On April 7, 2026, Biocon announced the U.S. commercial launch of Bosaya™ / Aukelso™ (denosumab-kyqq), biosimilars of Amgen’s Prolia® / Xgeva® (denosumab). Both products were approved by the U.S. Food and Drug Administration in September 2025 and were...

Biocon Files PGR Petition Challenging Regeneron Eylea® Patent and Seeks Joinder with Alvotech Proceeding

by April Breyer Menon | Apr 4, 2026

On April 2, 2026, Biocon filed a petition for post-grant review (“PGR”) challenging Regeneron’s U.S. Patent No. 12,168,036 (“the ’036 patent”), which is directed to methods for treating angiogenic eye disorders using high doses of VEGF receptor fusion proteins. The...

Amgen Settles BPCIA Litigation Against Henlius Over Prolia® / Xgeva® (denosumab) Biosimilars

by April Breyer Menon | Apr 1, 2026

On March 31, 2026, Amgen reached a settlement with Shanghai Henlius Biotech, resolving BPCIA litigation No. 1:25-cv-12160 (D.N.J.) / 1:25-md-03138 (D.N.J.) concerning Prolia® / Xgeva® (denosumab) biosimilars Bildyos® / Bilprevda® (denosumab-nxxp). This is the eighth...

FDA and EMA Accept Teva’s Omalizumab Biosimilar Applications

by April Breyer Menon | Mar 31, 2026

On March 30, 2026, Teva announced that the FDA and the European Medicines Agency (EMA) accepted regulatory submissions for its proposed biosimilar to Xolair® (omalizumab), TEV-45779. The submissions include a Biologics License Application (BLA) to the FDA and a...

FDA Approves Teva’s Denosumab Biosimilar Ponlimsi™ (denosumab-adet)

by April Breyer Menon | Mar 31, 2026

On March 30, 2026, the FDA approved Teva’s biosimilar Ponlimsi™ (denosumab-adet), referencing Amgen’s Prolia® (denosumab), for all indications of the reference product. Ponlimsi™ is the tenth Prolia® / Xgeva® (denosumab) biosimilar approved by the FDA....

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Methodology

Information contained in the Venable BiologicsHQ database relates to FDA-approved drug products listed in the CDER Purple Book or on the FDA website (www.fda.gov). Information relating to FDA licensed products, FDA-approved indications, and aBLA and 505(b)(2) applications is obtained from public sources including the U.S. FDA website (www.fda.gov). Information relating to litigations is given only for cases active from January 31, 2010 onward. Information relating to foreign biosimilar / biologics follow-on products approved in Australia, Canada, the E.U., Japan and South Korea is from public sources. Statistics graphics are compiled from information contained in the Venable BiologicsHQ database.

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