Global Biosimilar Developments

Winston & Strawn hosted an eLunch titled “Global Biosimilar Developments” on Wednesday, February 13, 2013 at 12:15 – 1:30 p.m. (Central). 

The development and use of similar biological medicinal products (biosimilars) is expected to increase dramatically in upcoming years as national health funds seek ways to slash healthcare budgets and pharmaceutical companies look to diversify product portfolios to spread and reduce risk. Their development differs significantly from small molecule pharmaceuticals and creates unique challenges and uncertainty in the approval process. Regulators in the European Union have developed a regulatory framework to deal with these issues and the United States is not far behind.

Winston & Strawn led this practical, interactive webinar that provided an update on regulatory developments and other hot button issues facing biosimilars in the U.S. and EU. The discussion focused on:

• History of biosimilar use and regulatory framework in EU
• Proposed U.S. framework and current areas of development
• What to expect – How biosimilar litigation compares with Hatch-Waxman Paragraph IV litigation
• Where the EU is going next with biosimilars and the possibilities for global biosimilar product developments

An eLunch is a complimentary, interactive seminar where participants watch and listen to a presentation given by Winston & Strawn attorneys over the Internet.

Clients and friends of the firm are invited to attend seminars and events. We reserve the right to limit attendance at any firm event.

NOTE: CLE credit is not available for listening to our pre-recorded eLunch or webinar briefings.