Roman Sinichkin /
26 September 2016Americas

FDA approves fourth biosimilar in US

The US Food and Drug Administration (FDA) has approved a biosimilar application by pharmaceutical company Amgen, the fourth such product to be rubberstamped in the country.

Called Amjevita (adalimumab-atto), it is a biosimilar of AbbVie’s drug Humira (adalimumab) and is approved for seven inflammatory diseases such as rheumatoid arthritis, ulcerative colitis and Crohn’s disease.

Janet Woodcock, director of the FDA’s center for drug evaluation and research, said: “This is the fourth FDA-approved biosimilar. The biosimilar pathway is still a new frontier and one that we expect will enhance access to treatment for patients with serious medical conditions.”

Amjevita’s approval was based on a review of evidence that included “structural and functional characterisation, animal study data, human pharmacokinetic and pharmacodynamics data, clinical immunogenicity data, and other clinical safety and effectiveness data that demonstrates Amjevita is biosimilar to Humira”, the FDA said.

Sean Harper, executive vice president of research and development at Amgen, said: “Approval of Amjevita is an exciting accomplishment as it marks a new chapter in Amgen’s story of being a leader in biotechnology.

“In addition, Amjevita holds the potential to offer patients with chronic inflammatory diseases an additional treatment option. This milestone exemplifies our ongoing dedication to the development of high-quality biologic medicines.”

Amgen’s biosimilar is also undergoing review by the European Medicines Agency, following a regulatory application submitted in December 2015.

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