April Breyer Menon, Author at Venable's BiologicsHQ

Fresenius Kabi and Celltrion Launch Prolia® / Xgeva® (denosumab) Biosimilars Conexxence™ / Bomyntra™ and Stoboclo® / Osenvelt®

by April Breyer Menon | Jul 15, 2025

On July 1, 2025, Fresenius Kabi announced the U.S. launch of Conexxence™ / Bomyntra™ (denosumab-bnht), biosimilars of Amgen’s Prolia® / Xgeva® (denosumab), pursuant to a settlement agreement between the parties ending BPCIA litigation No....

Amgen Files Three New Prolia® / Xgeva® BPCIA Litigations Against Hikma, Shanghai Henlius Biotech, and Biocon’s Proposed Biosimilars

by April Breyer Menon | Jul 3, 2025

On June 25, 2025, Amgen filed its sixth and seventh BPCIA lawsuits against proposed biosimilars of Prolia® / Xgeva® (denosumab), Case No. 1:25-cv-12152 (D.N.J.) against Hikma and Gedeon Richter’s RGB-14 and Case No. 1:25-cv-12160 (D.N.J.) against Shanghai...

Pembrolizumab Patent IPR Final Written Decision Issued and Director Review Requested

by April Breyer Menon | Jul 2, 2025

IPR Final Written Decision Finds Pembrolizumab Patent Claims Unpatentable On June 9, 2025, the Patent Trial and Appeal Board (“Board”) issued a Final Written Decision (“FWD”) in Merck’s IPR2024-00240 against The Johns Hopkins University’s (“JHU”) U.S. Patent No....

Sarepta Files Two IPRs Against Genzyme’s Patents Gene Therapy Elevidys® Allegedly Infringes

by April Breyer Menon | Jun 27, 2025

On June 26, 2025, Sarepta Therapeutics filed IPR2025-01194, challenging as obvious claims 3-6 of Genzyme’s U.S. Patent No. 9,051,542 (“the ’542 patent), and IPR2025-01195 challenging claims 1-4, 6-7 and 11 of U.S. Patent No. 7,704,721 (“the ’721 patent”) as...

Acting PTO Director Discretionarily Denies Celltrion’s IPR Against EYLEA® Patent

by April Breyer Menon | Jun 27, 2025

On June 25, 2025, Acting PTO Director Coke Morgan Stewart issued an opinion discretionarily denying Celltrion’s IPR2025-00456 against Regeneron’s U.S. Patent No. 11,084,865 (“the ’865 patent”). IPR2025-00456 relates to Celltrion’s proposed...

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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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