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.

AMCP Submits Comments on Draft CY2018 Medicare Part B Physician Fee Schedule Urging CMS to Critically Evaluate Coding & Reimbursement Options Under Part B to Ensure Patient Access and Affordability of Biologics and Biosimilars, Require Documentation of P

The Academy of Managed Care Pharmacy (AMCP) thanks the Centers for Medicare and Medicaid Services (CMS) for the opportunity to provide comments in response to the solicitation of public comments on biosimilars included in the proposed rule “Medicare Program; Revisions to Payment Policies under the Physician Fee Schedule and Other Revisions to Part B for CY 2018 [Docket No. CMS-1676-P]” as published in the Federal Register on July 21, 2017.
Biosimilars

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

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

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