Biosimilars 101: What are biosimilars and why should you care?

Presented by Dr. Richard Dolinar, MD

What are biosimilars
Why are biosimilars not generics
Manufacturing
The FDA’s “biosimilar pathway”
Policy Considerations

Latest News

ASBM Whitepaper: Lessons from European Biosimilar Markets

On March 25th, the Journal of the Generics and Biosimilars Initiative (GaBI Journal) published a whitepaper entitled Policy recommendations for a sustainable biosimilars market: lessons from Europe. The paper was authored by ASBM Executive Director Michael Reilly and Advisory Board Chair Philip Schneider. The biosimilar market in Europe is the largest in the world, representing approximately 60% of […]

ASBM Participates in DC Meetings on U.S. Biosimilar Market

On March 9th and 10th, two major meetings were held in the nation’s capitol to discuss the barriers to the success of biosimilars in the U.S. marketplace. The first meeting was a joint FDA/FTC Public Workshop held on March 9th at the FDA’s headquarters. The second was a half-day event sponsored by the Hatch Center, Pfizer, and the Biosimilars Forum […]

ASBM Leads Sessions at Festival of Biologics USA 2020

From March 2-4, ASBM representatives led multiple sessions at the World Biosimilar Congress USA, part of the Festival of Biologics USA 2020 held in San Diego, CA. ASBM Steering Committee Member Andy Spiegel, executive director of the Global Colon Cancer Association, participated in an opening “fireside chat” with Leah Christl, PhD. Dr. Christl formerly led the FDA’s […]