April Breyer Menon, Author at Venable's BiologicsHQ

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...

Samsung Bioepis and Formycon’s EYLEA® IPRs Discretionarily Denied Institution Among Wave of Fintiv Denials; Regeneron Files Second BPCIA Lawsuit Against Amgen’s Pavblu™

by April Breyer Menon | Jun 26, 2025

PTAB Denies Samsung Bioepis and Formycon’s IPR Petitions Under Fintiv On June 2, 2025, the Patent Trial and Appeal Board (“Board”) issued decisions denying institution of Samsung Bioepis’s IPR2025-00176 and Formycon’s IPR2025-00233 against claims...

Sandoz Launches Jubbonti® / Wyost® (denosumab-bbdz) as First Prolia® / Xgeva® Interchangeable Biosimilars

by April Breyer Menon | Jun 11, 2025

On June 2, 2025, Sandoz announced the launch of Jubbonti® / Wyost® (denosumab-bbdz), the first Prolia® / Xgeva® (denosumab) interchangeable biosimilars to launch in the U.S. Jubbonti® is indicated for increasing bone mass in patients with osteoporosis, prostate...

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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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