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FDA approves first Remicade biosimilar

Pfizer-Celltrion's Inflectra becomes the second biosimilar to be licensed in the US

Janssen's Remicade (infliximab) is set for a new type of competition after US regulators approved the first biosimilar version of its blockbuster arthritis treatment.

The FDA license for Inflectra makes the Celltrion-manufactured drug the second biosimilar to be approved in the US, and the first one based on a monocolonal antibody.

Janet Woodcock, director of FDA's Center for Drug Evaluation and Research, said: “Biosimilars can provide access to important treatment options for patients who need them.

“Patients and the health care community can be confident that biosimilar products are high quality and meet the agency's rigorous scientific standards.”

Remicade was the third biggest selling drug in the world in 2014 - bringing in $10.2bn - and will now face US pressure across all of its main indications, with Inflectra expected to be priced 20-30% lower than its originator.

HyoungKi Kim, chief executive officer at Celltrion, added: “Our experience with biosimilars outside the US suggests that Inflectra provides patients with both therapeutic and financial benefits, and we hope to see the same value provided in the US.”

Biosimilar versions of Remicade from Celltrion were launched in Europe last year. These included Inflectra from Hospira, which was subsequently acquired by Pfizer.

That company is now gearing up to market Inflectra in its six newly-licensed indications, including moderately to severely active rheumatoid arthritis.

Its approval from the FDA also includes moderately to severely active Crohn's disease in adults and children; adults with moderately to severely active ulcerative colitis; active ankylosing spondylitis; active psoriatic arthritis; and chronic severe plaque psoriasis.

Jenny Alltoft, head of global biosimilars at Pfizer, said: “We are committed to bringing these important medicines to patients in the US as quickly as possible.

“While launch timing for Inflectra will ultimately depend on a number of factors such as marketplace dynamics and intellectual property considerations, we are continuing with the preparation of our launch plans for 2016.”

The company will want to make the most of having the only anti-TNF, monoclonal antibody biosimilar on the US market given that the class of accounts for three of the four biggest selling medicines in the world. 

Chief among those is AbbVie's Humira (adalaimumab) and waiting in the wings is Amgen, which late last year submitted its biosimilar of that anti-TNF blockbuster to the FDA for US approval.

If all goes according to plan the biosimilar - known as ABP 501 - could be approved by the third quarter of this year. But Amgen - like Pfizer - will also have some intellectual property hurdles to vault. In Amgen's case AbbVie maintains Humira has patent protection in the US until 2022.

Ahead of that Amgen's own TNF blockbuster Enbrel (etanercept) is itself set for competition, with an FDA decision on Novartis' biosimilar version due in August.

Article by
Dominic Tyer

6th April 2016

From: Regulatory



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