April Breyer Menon, Author at Venable's BiologicsHQ

Tanvex Receives Third CRL for Proposed Herceptin® Biosimilar TX-05

by April Breyer Menon | Jun 27, 2026

On June 23, 2026, Tanvex received a Complete Response Letter (“CRL”) from the FDA for its proposed Herceptin® (trastuzumab) biosimilar TX-05 (trastuzumab), after resubmitting its application in December 2025. This is the third CRL Tanvex has received for TX-05. The...

Senate HELP Committee Advances Bills Addressing FDA / USPTO Disclosures and Biosimilar Interchangeability

by April Breyer Menon | Jun 23, 2026

On June 17, 2026, the U.S. Senate Committee on Health, Education, Labor and Pensions (“HELP”) voted to advance the Medication Affordability and Patent Integrity Act and the Biosimilar Red Tape Elimination Act. The Medication Affordability and Patent Integrity Act...

Janssen Files BPCIA Litigation Against Alvotech’s Proposed Simponi® / Simponi Aria® Biosimilar AVT05

by April Breyer Menon | Jun 23, 2026

On June 19, 2026, Janssen filed a BPCIA litigation, Case No. 1:26-cv-01754 (E.D. Va.) against Alvotech, alleging infringement of 14 of Janssen’s manufacturing patents by proposed Simponi® / Simponi Aria® (golimumab) biosimilar AVT05. Alvotech resubmitted its...

Alvotech Announces First FDA Acceptance of aBLA for Proposed Entyvio® Biosimilar – AVT16

by April Breyer Menon | Jun 11, 2026

On June 8, 2026, Alvotech announced that the FDA accepted for review its abbreviated Biologics License Application (“aBLA”) for AVT16, a proposed interchangeable biosimilar to Takeda’s Entyvio® (vedolizumab). AVT16 is the first publicly announced aBLA accepted by the...

Keytruda Qlex™ Updates: PTAB Finds Additional Halozyme PH20 Patent Unpatentable in Final Written Decision

by April Breyer Menon | Jun 11, 2026

On June 8, 2026, the Patent Trial and Appeal Board (“PTAB”) issued a Final Written Decision (“FWD”) in PGR2025-00004 finding all remaining challenged claims of Halozyme’s U.S. Patent No. 12,018,298 (“the ’298 patent”) unpatentable. The ’298 patent was challenged...

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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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