Developing and successfully commercializing a biosimilar is a complex and expensive process. On September 13, 2023, in the first webinar in Goodwin's 2023 Biosimilars Webinar Series, Goodwin IP Litigation partners and Big Molecule Watch editors, Naomi Birbach, Josh Weinger and Keith Zullow and, Goodwin IP Litigation associate and Big Molecule Watch editor, Alison Siedor will provide a broad overview of important strategic considerations that biosimilar makers should take into account before submitting an aBLA to increase the odds of a successful launch. Topics that will be covered include the 271(e) Safe Harbor, peremptory challenges, labelling and timing considerations, and competitive intelligence.
Click here to register for the webinar.
CLE credit will be offered for California, Minnesota, New Jersey, New York and Pennsylvania.
The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.