Biosimilar Resources

Biosimilars are biologic medicines that are highly similar to already approved reference products, offering comparable safety, efficacy, and quality at a reduced cost. Our resources provide information on the use, benefits, and regulatory guidelines of biosimilars to help healthcare professionals improve patient access and manage treatment costs effectively. To learn more about biosimilars and biologics visit AMCP's Biologics and Biosimilars Collective Intelligence Consortium (BBCIC) at bbcic.org.

Featured Resources

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AMCP Podcast Series Featured Episode
Podcast

The Buzz Around Biosimilars: AMCP’s Actions for 2023

2023 will be a pivotal year for biosimilar success or failure. Health care expert Fred Goldstein sits down with Stanton Mehr of Biosimilars Review & Report, to discuss what lies in store for biosimilars and AMCP’s biosimilar initiatives this year.
AMCP Podcast Series Featured Episode
Podcast

Humira Biosimilars are Here! What Now?

Health care expert Fred Goldstein sits down with Melissa Andel, principal and founder of CommonHealth Solutions, to discuss the long-awaited launch of Humira biosimilars and what Amgen’s pricing strategy means for patients and payers.
Webinars

Bracing for the Impact of Biosimilars: Navigating Terrain in the U.S. Market Landscape

  • Tuesday, Jun. 11, 2024 at 2-3pm ET
Resource

AMCP Summary: FDA Definition of the Term “Biological Product”

On Dec 12, 2018, FDA issued a new proposal to amend its regulation that defines “biological product” to incorporate changes made by the Biologics Price Competition Act of 2009 (BPCI Act). The BPCI Act amended the definition of biological product to include a “protein (except any chemically synthesized polypeptide.” To clarify these terms, FDA is proposing to provide its interpretation of the terms “protein” and “chemically synthesized polypeptide" to reduce regulatory uncertainty over what products are regulated as drugs or biological products.
Biosimilars
Letters, Statements & Analysis

AMCP Signs on to Stakeholder Letter in Support of H.R. 6478 - the Biosimilars Competition Act

We are writing to express our support for the Biosimilars Competition Act of 2018 (H.R. 6478). The undersigned stakeholders share your commitment to promoting a biosimilars market that will help reduce prescription drug costs for patients, payers, and taxpayers. We commend you for introducing this important legislation and look forward to working with you to enact it into law.
Biosimilars