On April 6th, ASBM submitted comments on the FDA’s recently published draft guidance outlining its current thinking on presenting data and information in a truthful and non-misleading way about biosimilars and reference products in FDA-regulated promotional materials. It addresses questions companies may have when developing these kinds of materials and provides examples that can help with specific […]

Read More

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 […]

Read More

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 […]

Read More