by April Breyer Menon | Oct 25, 2023
On October 23, 2023, Plaintiffs Genentech, Chugai, and Hoffmann-La Roche and Defendants Biogen and Bio-Thera filed a stipulation of dismissal in Case No. 1:23-cv-11573 (D. Mass.) due to settlement. The BPCIA litigation was filed in July 2023 (complaint), after the...
by April Breyer Menon | Oct 6, 2023
We are excited to announce Venable’s inaugural Life Sciences Webinar Series. This month-long series will explore the intricacies and latest developments that shape the life sciences industry. Join us as we hear from our seasoned attorneys across various practices who...
by April Breyer Menon | Oct 5, 2023
On September 18, 2023, the FDA issued a new draft guidance “Labeling for Biosimilar and Interchangeable Biosimilar Products,” updating the previous labeling guidance “Labeling for Biosimilar Products” from July 2018. According to the FDA, the significant changes from...
by April Breyer Menon | Sep 25, 2023
The Inflation Reduction Act (IRA), signed into law on August 16, 2022, allows the federal government to negotiate prices for some high-cost drugs covered under Medicare. Under the law, many small molecule and biologic drugs that do not have approved and marketed...
by April Breyer Menon | Aug 14, 2023
The Act’s Objectives USPTO data indicate that as many as 80% of instituted Patent Trial and Appeal Board (PTAB) proceedings that reach a final written decision (FWD) result in the invalidation of at least one challenged patent claim, with 65% of those proceedings...
by April Breyer Menon | Aug 7, 2023
At the beginning of July, seven additional Humira® (adalimumab) biosimilars, including one interchangeable, joined Amjevita™ (adalimumab-atto) in the US marketplace. Abrilada™ (adalimumab-afzb) is the only FDA-approved adalimumab biosimilar that has not...