On February 25, 2021, the U.S. Court of Appeals for the Seventh Circuit heard oral arguments in UFCW Local 1500 Welfare Fund v. AbbVie Inc. (Case No. 20-2402), a case appealed from the U.S. District Court for the Northern District
The Biosimilars Law Bulletin, published by Rothwell Figg, focuses on legal developments and regulatory issues related to biosimilar drugs. It covers topics such as FDA policies and guidance on biosimilar approval processes, patent litigation strategies involving biosimilars and branded biologics, legislative proposals affecting pharmaceutical patent law, and the impact of emerging technologies like AI on drug development and intellectual property. The blog also discusses market competition dynamics, interchangeability designations, and the evolving regulatory landscape influencing biosimilar entry and adoption in the pharmaceutical industry.
On February 23, 2021, a Federal Circuit panel of Chief Judge Prost, Judge Newman, and Judge Moore reheard oral argument in GlaxoSmithKline LLC v. Teva Pharms. USA, Inc. As discussed in our previous post, on February 9, 2021, the…
In a precedential opinion in Amgen Inc. et al. v. Sanofi, Aventisub LLC, et al., No. 20-1074 (Fed. Cir. 2021) issued on February 11, 2021, the Federal Circuit affirmed the decision of the United States District Court for the District…
On January 28, 2021, Bio-Thera Solutions, Ltd., a biopharmaceutical company based in China, announced that the U.S. Food and Drug Administration (FDA) accepted its Biologics License Application (BLA) for BAT1706, a proposed biosimilar to bevacizumab, referencing Genentech’s Avastin®, but excluding…
The COVID-19 relief and spending bill signed into law on December 27, 2020, includes a provision – Division BB, Title III, Subtitle C, Section 325[1] – that adds a new paragraph 9 to 42 U.S.C. §262(k) requiring the U.S. Food…