The US Food and Drug Administration’s (FDA) Arthritis Advisory Committee last month unanimously supported Amgen’s drug candidate ABP 501 as a biosimilar to Abbvie’s Humira (adalimumab). Amgen is seeking to license ABP 501 for the same indications as Humira: rheumatoid arthritis (RA) and plaque psoriasis (PsO); as well as ankylosing spondylitis, adult Crohn’s disease, and adult ulcerative colitis.
The FDA describes biosimilars in a regulatory context as biological products that are approved based on evidence showing they are highly similar to, and have no clinically meaningful differences, in terms of safety and effectiveness compared with a previously FDA-licensed biological product known as a ‘reference product’. Only minor differences in clinically inactive components are allowed in biosimilar products.
The active ingredient of ABP 501 is an anti-TNF- monoclonal antibody that has the same amino acid sequence as Humira, and the same pharmaceutical dosage form, strength, and route of administration. Humira was initially licensed by the FDA in 2002, and is among the world’s most profitable drug product, reportedly accounting for 60 percent of Abbvie’s total 2015 revenues. Amgen’s biosimilar ABP 501, if approved by the FDA as a biosimilar, could introduce price competition and save insurers, physicians and patients billions of dollars according to a Rand Corporation analysis.
At the FDA meeting, Amgen presented analytical, nonclinical, clinical, and pharmacokinetic data supporting ABP 501’s biosimilarity to Humira, including results from two Phase 3 studies investigating its performance in treating moderate-to-severe plaque psoriasis and moderate-to-severe rheumatoid arthritis respectively. Amgen said the Phase 3 studies met their primary endpoints showing ABP 501’s clinical comparability to Humira, and that its safety and immunogenicity characteristics were also shown to be comparable to the reference product. Data to support the transition of Humira patients to ABP 501 were included in Amgen’s submission. The committee’s vote to support ABP 501 biosimilars approval is non-binding, but helps smooth the way toward eventual approval.
“As a developer of innovative medicines and biosimilars, Amgen has worked diligently to apply our more than 35 years of experience in biotechnology to the development of biosimilars,” said Dr. Sean E. Harper, Amgen’s executive vice president of research and development in a press release prior to the vote. “If approved, ABP 501 has the potential to provide an additional treatment option for patients with chronic inflammatory diseases.”
According to the Competition and Innovation Act of 2009, passed as part of the Affordable Care Act signed into law by President Obama in 2010, the abbreviated licensure pathway for biological products shown to be biosimilar to, or interchangeable with, an FDA-licensed biological reference product permits reliance on certain existing scientific knowledge about the reference product’s safety and effectiveness. Licensure of a biosimilar product can be based on less than a complete program of nonclinical and clinical data that typically include animal studies and clinical trials.
According to the Amgen press release, the FDA could reveal its final decision by Sept. 25, 2016. If approved, the product will could be available by 2018.
Biosimilar products are different from generic drugs. Generics are copies of brand-name drugs on which proprietary patents have expired, that have the same active ingredient, and are similar to the brand name drugs in dosage form, safety, strength, route of administration, quality, performance characteristics and intended use, meaning that the brand-name and generic products are “bioequivalent.” Biosmilars are highly similar to the reference product but have allowable differences because they are made from living organisms.