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Amgen's Humira biosimilar moves closer to US approval

FDA committee backs company's version of AbbVie's blockbuster

Amgen's version of AbbVie's big-selling Humira has moved a step closer to US approval with a unanimous vote in favour of the new drug by one of the FDA's influential committees.

Amgen put in a Biologics License Application (BLA) for ABP 501 with the FDA's Arthritis Advisory Committee and will now be looking forward to a green light - even though the regulator is not bound to follow its committees' advice.

AbbVie will be wary of the competition, which could see millions being knocked off its sales in the next few years: a hugely successful blockbuster, Humira (adalimumab) is responsible for 60% of its revenues.

Humira is an anti-tumor necrosis factor-alpha (TNF-α) monoclonal antibody, approved in many countries for the treatment of several inflammatory diseases.

Amgen said it was presenting “analytical, nonclinical, clinical and pharmacokinetic data” to the FDA, which included results from two phase III studies of ABP 501 in moderate-to-severe plaque psoriasis and moderate-to-severe rheumatoid arthritis.

These studies met their primary endpoints showing clinical comparability to adalimumab. Safety and immunogenicity were also comparable to adalimumab.

Sean Harper, Amgen's executive vice president of R&D, said: “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.

“If approved, ABP 501 has the potential to provide an additional treatment option for patients with chronic inflammatory diseases, as well as play a key role in long-term disease management.”

The FDA has set a Biosimilar User Fee Act (BsUFA) target action date of September 25 for ABP 501.

Some analysts believe that Humira may be showing its age in sales terms - but its performance is still impressively robust, with annual sales of over $14bn making it the world's biggest-selling brand.

As well as competition from biosimilars such as ABP 501, Humira could also face increasing competition from new molecular entities (NMEs) including Lilly and Incyte's baricitinib, which could be available for prescribing later this year. In trials, baricitinib outperformed Humira on some outcome measures in rheumatoid arthritis patients. 

Article by
Adam Hill

13th July 2016

From: Regulatory



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