by April Breyer Menon | Sep 30, 2022
On September 19, 2022, the European Medicines Agency (EMA) and the Heads of Medicines’ Agencies (HMA) issued a joint statement explaining their scientific rationale for determining that biosimilars approved in the EU are interchangeable with their reference product...
by April Breyer Menon | Aug 31, 2022
Cimerli™ (ranibizumab-eqrn) was FDA approved on August 2, 2022 as interchangeable with Lucentis® (ranibizumab). Cimerli is the third interchangeable biosimilar approved in the US, following Semglee® (insulin glargine-yfgn), interchangeable with Lantus®...
by April Breyer Menon | Jul 19, 2022
Venable’s Ha Kung Wong and April Breyer Menon break down the issues that digital health and precision medicine face with IP and the history of case law that has created the current landscape for the Center for Biosimilars. Precision medicine is changing the...
by April Breyer Menon | May 29, 2022
Interim Director Hirshfeld’s Authority to Review Upheld On May 27, 2022, in Arthrex Inc. v. Smith & Nephew Inc., Case No. 18-2140, the Federal Circuit upheld the ability of Acting Director Drew Hirshfeld to issue Director review decisions, despite being a...
by April Breyer Menon | Feb 28, 2022
Download...
by April Breyer Menon | Feb 18, 2022
Venable’s Ha Kung Wong and April Breyer Menon delve into the practical implications of the US Supreme Court’s ruling in U.S. v. Arthrex, including the outcomes of requests for director review, time to decision on the requests, and potential future issues with...