According to a briefing document released by the U.S Food and Drug Administration (FDA) Arthritis Advisory Committee, a drug designed as a biosimilar to adalimumab (ADA) is “highly similar” to it its reference product Humira©, manufactured by AbbVie.1 This document was released ahead of a meeting of FDA advisors that will take place on July 12, 2016, where the decision to recommend approval of the new biosimilar, ABP 501, will be made.
Currently, AbbVie owns the biologics license application (BLA) for the ADA reference product (RP) Humira©, initially licensed by the FDA on December 31, 2002. Amgen, the manufacturer of ABP 501, intends to seek licensure for its product for all the currently approved indications of its RP, including rheumatoid arthritis (RA), psoriatic arthritis, and anyklosing spondylitis.
A biosimilar is a biological product that is approved based on showing that it is highly similar to the existing biological product, known as the RP. Differences in clinically inactive components, however, may still exist.
The Biologics Price Competition and Innovation Act of 2009 (BPCI Act) was enacted in the U.S. as part of a larger reform with the Affordable Care Act, designed to shorten the pathway to drug licensure for biological products that are shown to be “biosimilar” to an already FDA-licensed biological product.
Biosimilarity is defined by the BPCI act as “the biological product is highly similar to the RP notwithstanding minor differences in clinically inactive components” and that “there are no clinically meaningful differences between the biological product and the RP in terms of the safety, purity, and potency of the product.”2
Though Amgen intends to seek licensure for ABP 501 for all the indications for which US-licensed Humira© is licensed, the ABP 501 clinical program, however, provided clinical efficacy and safety data primarily from clinical studies including patients with RA and psoriasis.
Summary and Clinical Applicability
“The comparison of the structural and functional properties of the clinical and commercial product lots of ABP 501 and US-licensed Humira© supports a demonstration that they are highly similar, notwithstanding minor differences in clinically inactive components” the FDA arthritis committee briefing document concluded.1
The findings outlined in this briefing will be discussed by the Arthritis Advisory Committee on July 12, 2016. Rheumatology Advisor will report their findings.
The FDA background briefing document reflects recommendations written by individual FDA reviewers. Such conclusions and recommendations do not necessarily reflect the final position of the FDA.
1. U.S. Food and Drug Administration. FDA Briefing Document: Arthritis Advisory Committee Meeting. BLA 761024 ABP 501, a proposed biosimilar to Humira (adalimumab).
http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/ArthritisAdvisoryCommittee/UCM510293.pdf Released to public online on July 8, 2016. Accessed July 8, 2016.
2.U.S. Food and Drug Administration. Information for Healthcare Professionals (Biosimilars).
http://www.fda.gov/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/TherapeuticBiologicApplications/Biosimilars/ucm241719.htm Updated online May 10, 2016. Accessed July 8, 2016.