Biosimilars Webinar Series

In continuation of Goodwin’s previous webinar series concerning biosimilars, our 2023-2024 webinar series will dive deep into some of the key topics pertaining to this burgeoning industry and corresponding area of law.

Stay tuned for more details below, including registration information for upcoming webinars.

Please note that our webinar and event recordings are for informational purposes only. CLE credit is only available for our guests attending live webinars and other specified events.

September 13, 2023 | 12:00 PM – 1:00 PM EDT

Successfully developing and commercializing a biosimilar is a complex and expensive process. This webinar provided 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 covered include the 271(e) Safe Harbor, peremptory challenges, labelling and timing considerations, and competitive intelligence.

Speakers:
Naomi Birbach
Josh Weinger
Alison Siedor

October 12, 2023 | 12:00 PM – 1:00 PM EDT

The world of biosimilar litigation is back in full swing with several BPCIA lawsuits currently pending. This webinar covered strategies and considerations during pre-litigation disclosures under the BPCIA (the so-called “patent dance”) and in BPCIA litigation with a particular focus on what we have learned from the most recent wave of BPCIA litigations. We discussed considerations for the timing of filing an aBLA, strategies for disclosure during the patent dance and early litigation, and key issues during BPCIA litigation from a reference product sponsor and biosimilar applicant perspective.

Speakers:
Elaine Blais
Natasha Daughtrey
Alexandra Valenti

November 14, 2023 | 12:00 PM – 1:00 PM EDT

In an update to Goodwin’s May 2020 webinar regarding Biosimilar challenges at the PTAB, this webinar explored topics including:

Evolving trends of biologic patent challenges at the PTAB;
Strategic considerations for biosimilar manufacturers;
Lessons learned from recent filings.

Speakers:
Linnea Cipriano
James Breen
Christine Potkay

January 30, 2024 | 12:00 PM – 1:00 PM EDT

This webinar will provide an overview of the players, products, and regulatory and legal schemes of the biosimilars market, as well as an update on patent linkage litigation in China.

Speakers:
Huiya Wu
Yoko Bian

March 13, 2024 | 12:00 PM – 1:00 PM EDT

More details to come!

Speakers:
Matt Wetzel

More details to come!

Speakers:
Tiffany Mahmood
Kevin DeJong