April Breyer Menon, Author at Venable's BiologicsHQ

Keytruda Qlex™ Updates: Final Written Decisions Find Two Halozyme PH20 Patents Unpatentable While Institution is Denied for Third Patent

by April Breyer Menon | May 22, 2026

On May 12, 2026, the Patent Trial and Appeal Board (“PTAB”) issued a Final Written Decision (“FWD”) in PGR2025-00003 finding all challenged claims of Halozyme’s U.S. Patent No. 11,952,600 (“the ’600 patent”) unpatentable. On May 15, 2026, the Director of the U.S....

PTAB Denies Institution of Two Elevidys® Gene Therapy IPRs

by April Breyer Menon | May 18, 2026

On May 15, 2026, the Director of the U.S. Patent and Trademark Office issued summary institution decisions denying institution on the merits of two additional inter partes review (“IPR”) proceedings, IPR2026-00167 and IPR2026-00168, filed by Sarepta Therapeutics, Inc....

Accord’s Immgolis™ / Immgolis Intri™ (golimumab-sldi) Approved as First Simponi® / Simponi Aria® (golimumab) Interchangeable Biosimilars

by April Breyer Menon | May 18, 2026

On May 15, 2026, the FDA approved the first biosimilars of Janssen’s Simponi® / Simponi Aria® (golimumab), Accord and Bio-Thera’s Immgolis™ / Immgolis Intri™ (golimumab-sldi). Both biosimilars were approved with skinny labels. Immgolis™ is...

PTAB Denies Institution of One Elevidys® IPR and Institutes Another

by April Breyer Menon | May 8, 2026

On May 6, 2026, the Director of the U.S. Patent and Trademark Office issued bulk order institution decisions in two inter partes review (“IPR”) proceedings filed by Sarepta Therapeutics, Inc. against Genzyme relating to patents associated with gene therapy products,...

FDA Approves Interchangeable Insulin Glargine Biosimilar Langlara™ (insulin glargine-aldy)

by April Breyer Menon | May 7, 2026

On April 29, 2026, the U.S. Food and Drug Administration (FDA) approved Sunshine Lake Pharma’s Langlara™ (insulin glargine-aldy) biosimilar to Sanofi’s Lantus® (insulin glargine), for the treatment of adult and pediatric patients with type 1 diabetes and adults...

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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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