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

See All in Biosimilars
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
Letters, Statements & Analysis

AMCP Delivers Remarks on Biosimilars Position at FDA Oncologic Drug Advisory Committee Meeting

AMCP supports the implementation of a robust biosimilars pathway to ensure that Americans continue to receive access to safe, effective, and affordable biologics and biosimilars. AMCP has been working extensively with the Food and Drug Administration and other stakeholders on federal and state legislation and regulations that impact the biosimilars pathway.
Biosimilars
Letters, Statements & Analysis

AMCP Submits Comments to FDA on BsUFA II Reauthorization, Citing a Need for Robust Biosimilars Education, Expeditious and Harmonious Guidance Documents, and Post-Market Surveillance

The Academy of Managed Care Pharmacy (AMCP) thanks the Food and Drug Administration (FDA) for the opportunity to provide comments on the reauthorization of the Biosimilar User Fee Act (BsUFA) for fiscal years 2018 through 2022 as published in the Federal Register on September 13, 2016. These written comments are provided in addition to the oral comments AMCP will present at the public meeting on October 20, 2016.
Biosimilars
Press Releases

BBCIC Announces Major Milestone; Prepares for Comparative Effectiveness and Safety Studies of Biosimilars Coming to Market in 2017

Press Release: The Biologics & Biosimilars Collective Intelligence Consortium (BBCIC) this month reached a significant new phase of operation, posting research protocols that will lay the groundwork for comparative effectiveness and safety studies of biosimilars currently available or projected to enter the market next year.
Biosimilars
Letters, Statements & Analysis

AMCP Submits Comments to FDA on Biosimilars Labeling Draft Guidance Advocating for Changes to the Biosimilarity Statement and Biosimilar Product Identification & Naming Sections

The Academy of Managed Care Pharmacy (AMCP) thanks the Food and Drug Administration (FDA) for the opportunity to provide comments in response to the draft guidance document titled “Labeling for Biosimilar Products: Guidance for Industry” published in the Federal Register on April 4, 2016.
Biosimilars
Letters, Statements & Analysis

AMCP Joins Other Organizations Urging Senate not to Approve Legislative Provision to Remove Requirement for USP Monographs for Biologics and Biosimilars

AMCP is writing to express concern about proposals by the Food and Drug Administration (FDA) and a provision included in Section 11 of the “FDA and NIH Workforce Authorities Modernization Act” (S. 2700) that would exempt certain biological products, including biosimilars, from the requirement to adhere to U.S. Pharmacopeial (USP) public standards for quality, including the naming of biologic and biosimilar medicines.
Biosimilars
Letters, Statements & Analysis

AMCP Submits Comments to the Ohio Senate Health and Human Services Committee, Opposing Sub. HB No. 505, a Bill Concerning Biosimilars

The Academy of Managed Care Pharmacy (AMCP) appreciates the opportunity to comment on Sub. H.B. No. 505 regarding the regulation of biological products and the substitution of interchangeable biological products when dispensed by pharmacists. AMCP is opposed to this legislation as it places an undue burden on the dispensing of interchangeable biological products once approved by the FDA.
Biosimilars
Letters, Statements & Analysis

AMCP Submits Comments on Hawaii HB 254 Concerning Biosimilars

The Academy of Managed Care Pharmacy (AMCP) is writing to express its opposition to certain provisions of H.B. No. 254. AMCP opposes the practitioner notification requirements, which would place an unnecessary burden on the substitution of an interchangeable biological drug product. In addition, AMCP also opposes the new definition of “interchangeable biological product” included in the bill, which is not consistent with the Food and Drug Administration (FDA) definition.
Biosimilars