FDA Staff Back Biosimilar to Compete With Blockbuster Humira

Competition for one of the world’s top-selling biologics – AbbVie’s Humira (adalimumab) – is likely to come in the near future, as staff at the US Food and Drug Administration (FDA) said Friday that Amgen’s biosimilar has “no clinically meaningful differences” with the US-licensed Humira, in terms of safety, purity and potency.

Amgen’s biosimilar will go before an FDA advisory committee next Tuesday, and if it is eventually approved (FDA has a deadline of 25 September 2016 to decide), it would be the third biosimilar approved in the US.

Amgen has been working on its biosimilar version of Humira since at least 2011 and has conducted two nonclinical studies to support its biologics license application (BLA), provided pharmacokinetic (PK) data from three studies and submitted clinical safety, immunogenicity and efficacy data from two clinical studies.

“Specifically, the results from the comparative clinical efficacy, safety, and PK studies,…adequately supports a demonstration that there are no clinically meaningful differences between ABP 501 and US-licensed Humira in RA [rheumatoid arthritis] and PsO [plaque psoriasis],” according to briefing documents released ahead of the committee meeting.

“In considering the totality of the evidence, the data submitted by the Applicant support a demonstration that ABP 501 is highly similar to US-licensed Humira, notwithstanding minor differences in clinically inactive components, and support a demonstration that there are no clinically meaningful differences between ABP 501 and US-licensed Humira in terms of the safety, purity, and potency of the product,” agency staff noted.

FDA also noted that Amgen provided “an extensive data package to address the scientific considerations for extrapolation of data to support biosimilarity to other conditions of use to support their request that ABP 501 should receive licensure for the indications for which US-licensed Humira is currently licensed and for which Amgen is seeking licensure.”

Tuesday’s committee of outside experts will discuss whether the evidence supports a demonstration that there are no clinically meaningful differences between ABP 501 and US-licensed Humira in the studied conditions of use – rheumatoid arthritis (RA) and plaque psoriasis (PsO), as well as whether the data can support a demonstration of no clinically meaningful differences between ABP 501 and US-licensed Humira for the additional indications for which Humira is licensed:  

• Juvenile idiopathic arthritis in patients 4 years of age and older
• Psoriatic arthritis
• Ankylosing spondylitis
• Adult Crohn’s disease
• Adult ulcerative colitis

FDA Briefing Document: Arthritis Advisory Committee Meeting, July 12, 2016

Advisory Committee Draft Questions

Other Meeting Materials