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FDA gives the green light to the first Humira biosimilar

Published on 26/09/16 at 09:17am

Amgen’s Amjevita has been given the go ahead for all eligible indications of its reference product, including moderate-to-severe rheumatoid arthritis, moderate-to-severe polyarticular juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, moderate-to-severe chronic plaque psoriasis, adult moderate-to-severe Crohn's disease and moderate-to-severe ulcerative colitis.

The approval comes on the back of analytical, nonclinical, pharmacokinetic and clinical data that displays a biosimilarity between Amjevita and Humira. This includes the results from two Phase III studies conducted in moderate-to-severe plaque psoriasis and moderate-to-severe rheumatoid arthritis, where the patients met their primary endpoint showing clinical and safety equivalence.

Humira, which is an anti-TNF monoclonal antibody, draws annual sales of close to $15 billion across its range of indications for inflammatory diseases. Amgen has not yet indicated pricing data but their offering is expected to reach the market at a significantly cheaper price and healthcare providers, therefore, stand to make substantial savings.

The major stumbling block for Amgen is that there is the potential that they will not be able to launch the drug until 2022. This is due to AbbVie’s claim that Amjevita infringes patent protection on Humira, which is valid until 2022. The case is currently going through the US court for the District of Delaware.

AbbVie is quoted as arguing that “whereas [we] have spent decades of research and vast resources on the development of Humira [adalimumab], Amgen seeks to copy AbbVie’s work and ignore AbbVie’s patents”, and “while the Biosimilar Price Competition and Innovation Act gives Amgen an abbreviated regulatory pathway for its biosimilar version of Humira, it does not give Amgen license to infringe AbbVie’s patents.” AbbVie’s lawsuit claims that Amgen’s product infringes upon 10 of Humira’s patents, and with more legal action expected to follow, it could be a long road before Amjevita reaches the market.

Ben Hargreaves

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