Join Michael Siekman, Allegra Padula, and Riley Wyberg as they open our webinar series with “The BPCIA Has Changed How Companies Should Be Protecting Innovative Biologics and Biosimilars—Has Your Company Changed Its Strategy?” on November 18th at 2:00 PM EST. The data regarding which patents are being asserted over 10…
Huiya Wu and Michael Siekman’s article, Are Reference Product Sponsors Asserting More Patents in BPCIA Litigation? was recently published in the IP Litigator’s February Issue. The IP Litigator is an online publication that provides regular updates on the latest strategies for handling intellectual property (IP) lawsuits and enforcement. Each issue includes…
On January 7, 2025, the FDA issued a draft guidance called Considerations for the Use of Artificial Intelligence to Support Regulatory Decision-Making for Drug and Biological Products. The document clarifies how sponsors, manufacturers, and other industry developers should approach artificial intelligence (AI) to support safe, effective development and marketing of AI-based…
As regular Big Molecule Watch readers know, the Biologics Price Competition and Innovation Act (“BPCIA”) was signed into law as part of the Affordable Care Act on March 23, 2010, creating an abbreviated licensure pathway for “biosimilar” and “interchangeable” biological products. The BPCIA also introduced a new scheme to resolve…