USFDA says Amgen’s Humira biosimilar meets ‘highly similar’ threshold

With billions at stake, Amgen’s biosimilar of AbbVie megablockbuster Humira won the unanimous backing of an FDA panel Tuesday, putting the company just an FDA approval away from a potentially huge sales haul and placing AbbVie on the edge of steep patent cliff.

For the second time this week, a biosimilar has won the backing of the FDA’s arthritis advisory panel.

During the meeting, some members of the FDA’s Arthritis Advisory Committee expressed some concern about data presented by Amgen about ABP 501’s safety.

Some analysts expect the biosimilar drug to be available well before 2022 and foresee sales of adalimumab falling by as much as 18% in 2019.

The AdComm rec means Amgen-which is both threatening a blockbuster with its biosim and under attack from a Sandoz Enbrel biosim-could see its biosimilar approved by a September 25 BsUFA date.

“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 Sean E. Harper, M.D., executive vice president of research and development at Amgen. “We look forward to continuing to work with the FDA as they complete their review of Amgen’s BLA for ABP 501”. At the same time, Credit Suisse analyst Vamil Divan expects AbbVie’s “broad patent estate” to protect Humira from cheaper competitors in the United States until 2021.

Amgen is seeking FDA approval for ABP 501 for indications for which Humira is approved including rheumatoid arthritis (RA), juvenile idiopathic arthritis (JIA), psoriatic arthritis (PsA), ankylosing spondylitis (AS), adult Crohn’s disease (CD), ulcerative colitis (UC), plaque psoriasis (PsO) – all in specific patient populations.

Enbrel was approved in 1998 and generated more than $5 billion in US sales a year ago.

This is one of the greatest sources of controversy in the sector, and why ongoing court actions between Amgen and Abbvie will be closely watched – in part, because the case law that emerges could define the terms of biosimilar entry for years to come. The data is backed by analytical, nonclinical, clinical and pharmacokinetic parameters in two Phase 3 studies, carried out with patients inflicted with moderate-to-severe plaque psoriasis, and moderate-to-severe rheumatoid arthritis. Sales of the drug were $14 billion past year. Novartis’ Zarxio sells for 15 percent less than the original Neupogen.