April Breyer Menon, Author at Venable's BiologicsHQ

PTAB Grants Institution of Three PGRs related to Merck’s Keytruda Qlex™

by April Breyer Menon | Oct 10, 2025

Beginning in November 2024, Merck Sharp & Dohme, LLC (“Merck”) requested post-grant review (“PGR”) of 14 patents owned by Halozyme, Inc. (“Halozyme”), with claims directed to modified PH20 hyaluronidase polypeptides, including modified polypeptides that exhibit...

PTAB Grants Amgen’s Request for Adverse Judgment Prior to Institution of Trial in Opdivo® IPR2025-00603

by April Breyer Menon | Oct 5, 2025

On October 1, 2025, the PTAB granted Amgen’s request for adverse judgment based on Bristol-Myers Squibb’s (“BMS”) statutory disclaimer of all challenged claims prior to institution of trial. Amgen’s IPR2025-00603 challenged all the claims of BMS’s U.S. Patent...

Celltrion launches Actemra® Biosimilar Avtozma®

by April Breyer Menon | Oct 4, 2025

On October 2, 2025, Celltrion launched Avtozma® (tocilizumab-anoh), in intravenous and subcutaneous formulations, as the third biosimilar of Genentech’s Actemra® (tocilizumab). Avtozma® was approved by the FDA on January 24, 2025 (previously reported FDA Approves...

FDA Approves Prolia® / Xgeva® (denosumab) Biosimilars: Henlius’s Bildyos® / Bilprevda®, Biocon’s Bosaya™ / Aukelso™, and Gedeon Richter’s Enoby™ / Xtrenbo™

by April Breyer Menon | Oct 1, 2025

On October 1, 2025, the FDA approved Gedeon Richter / Hikma’s Enoby™ / Xtrenbo™ (denosumab-qbde), biosimilars of Amgen’s Prolia® / Xgeva® (denosumab). This is the seventh Prolia® / Xgeva® biosimilar approval, and follows Biocon’s Bosaya™ /...

Amgen and Biocon Reach Settlement in Prolia® / Xgeva® Biosimilar Litigation

by April Breyer Menon | Sep 30, 2025

On September 30, 2025, Amgen and Biocon Biologics reached a settlement in Case No. 1:25-cv-13358 (D.N.J.) / MDL 1:25-md-03138 (D.N.J.). The litigation related to Biocon’s Prolia® / Xgeva® (denosumab) provisionally interchangeable biosimilars Bosaya™ /...

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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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