Amgen have moved a step closer to bringing a biosimilar competitor to AbbVie’s Humira to the US market after the FDA approved its copycat version of the $14bn-a-year brand.
The approval is however just the first step in what is likely to be a long journey before the biosimilar – called Amjevita (adalimumab-atto; formerly ABP 501) – can be prescribed to patients.
As with all biosimilars there is an automatic 180-day pre-marketing notice period before Amgen can launch. Meanwhile AbbVie has already filed a lawsuit against Amgen claiming that Amjevita infringes patents on Humira (adalimumab).
Amgen could feasibly launch its biosimilar before that dispute is resolved but could put itself at risk of punitive damages if the case did not ultimately go its way. AbbVie is claiming patent protection for Humira in the US out to 2022 and has sought an injunction in its lawsuit to keep Amjevita off the market even after it has been approved by the FDA.
AbbVie will no doubt fight tooth and nail to keep Humira clear of competition, as the product still accounts for 60% of its revenues despite efforts to diversify into new areas such as hepatitis C.
Amjevita has been approved for all seven of Humira’s uses – rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, psoriasis, Crohn’s disease and ulcerative colitis – and is the first biosimilar in Amgen’s portfolio to reach the registration stage.
The biosimilar won the unanimous backing of an FDA advisory committee in July and is only the fourth biosimilar to be approved by the US regulator.
“The biosimilar pathway is still a new frontier and one that we expect will enhance access to treatment for patients with serious medical conditions,” said Janet Woodcock, director of the FDA’s Center for Drug Evaluation and Research (CDER).
The green light “marks a new chapter in Amgen’s story of being a leader in biotechnology,” said Sean Harper, the company’s head of R&D.
Other biosimilars in the company’s late-stage pipeline include versions of Roche’s breast cancer drug Herceptin (trastuzumab) and colorectal and lung cancer therapy Avastin (bevacizumab).