April Breyer Menon, Author at Venable's BiologicsHQ

Fresenius Kabi and Dr. Reddy’s Announce Rituxan® Biosimilar Zimrixby™ (rituximab-cdxx) FDA Approval

by April Breyer Menon | Aug 5, 2026

On August 3, 2026, Fresenius Kabi and Dr. Reddy’s announced the FDA-approval of Zimrixby™ (rituximab-cdxx), a biosimilar of Genentech’s Rituxan® (rituximab). Zimrixby™ is the fourth Rituxan® biosimilar approved in the U.S. Truxima® (rituximab-abbs) was...

Impact of USPTO Directors Stewart and Squires on Pharmaceutical Patent Challenges at the PTAB

by April Breyer Menon | Aug 3, 2026

Changes at the Patent Trial and Appeal Board (“PTAB”) since early 2025 have significantly altered the landscape for patent challenges in a more pro-patent direction, with control of proceedings increasingly centralized with the U.S. Patent and Trademark Office (“PTO”)...

Fresenius Kabi and Polpharma Submit aBLA for Proposed Entyvio® (vedolizumab) Biosimilar PB016

by April Breyer Menon | Aug 2, 2026

On July 31, 2026, Fresenius Kabi and Polpharma announced the FDA acceptance of their aBLA for PB016 (vedolizumab), a proposed intravenous biosimilar of Takeda’s Entyvio® (vedolizumab). They also announced the acceptance of their Marketing Authorisation Application...

Genentech Files BPCIA Litigation Against Biocon’s Proposed Perjeta® Biosimilar Bmab 1500

by April Breyer Menon | Jul 31, 2026

On July 29, 2026, Genentech filed BPCIA litigation No. 2:26-cv-09585 (D.N.J.) against Biocon’s proposed Perjeta® (pertuzumab) biosimilar Bmab 1500. Genentech asserted 28 patents, including 14 with manufacturing claims, 11 with method of treatment claims, four with...

Congressional Committees Advance Biosimilar Bills Addressing Clinical Study Requirements and Interchangeability

by April Breyer Menon | Jul 28, 2026

On July 22, 2026, the U.S. Senate Committee on Health, Education, Labor and Pensions (“HELP”) voted to advance the Expedited Access to Biosimilars Act (S. 1414). The Senate action followed the introduction of a House version of the bill (H. R. 9661) and consideration...

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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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