by April Breyer Menon | Nov 22, 2023 | Focus, News
On November 8, 2023, Regeneron Pharmaceuticals Inc. filed a BPCIA Complaint against Celltrion Inc. in the district court for the northern district of West Virginia, asking the Court to block CT-P42 – Celltrion’s proposed biosimilar of Regeneron’s drug...
by April Breyer Menon | Nov 5, 2023 | Focus, News
On October 31, 2023, the FDA approved Amgen’s Wezlana™ (ustekinumab-auub) as the first biosimilar and interchangeable of Johnson & Johnson / Janssen’s Stelara® (ustekinumab). In May 2023, Amgen and Janssen settled their BPCIA lawsuit, with an agreement...
by April Breyer Menon | Oct 6, 2023 | Focus, News
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 | Focus, News
On September 18, 2023, the FDA issued a new draft guidance “Labeling for Biosimilar and Interchangeable Biosimilar Products,” updating the previous labeling guidance “Labeling for Biosimilar Products” from July 2018.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 | Focus, News
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 | Focus, News
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...