FDA approves Remicade biosimilar, uncertainty over launch date

The US Food and Drug Administration has approved Celltrion’s biosimilar of Johnson & Johnson’s Remicade (infliximab) – but the launch date of the blockbuster’s cheaper rival remains uncertain.

This is only the second drug to be approved via the FDA’s biosimilar pathway and is the first time the regulator has approved a near-copy of a complex monoclonal antibody.

Sales of the treatment for rheumatoid arthritis and other inflammatory diseases have already been hit by biosimilar competition in Europe. Remicade is marketed here by MSD, and it has seen sales fall from $2.37 billion in 2014 to $1.8 billion in 2015.

But in the US, Remicade generated sales of just under $4.5 billion last year, an increase of 7.2% compared with 2014. However it is unclear when Pfizer will be able to market the Remicade rival under the brand name Inflectra, as part of a deal struck with Celltrion by its Hospira unit in 2009.

The originator’s composition patent expires in 2018 and last year J&J sued Celltrion, saying the biosimilar would infringe a series of patents, one of which runs until 2027.

Pfizer said that it plans to launch the biosimilar this year, but said the date depends “on a number of factors such as marketplace dynamics and intellectual property considerations.”

Celltrion’s chief executive, Kim Hyoung-ki said yesterday in a briefing with reporters that the biosimilar will be priced around 20%-30% lower than Remicade in the US, where it will be marketed by Pfizer.

A final price will be decided after discussions with Pfizer, he said.

Known by the generic name of infliximab-dyyb because of the FDA’s naming conventions, the biosimilar has been approved for all the uses of the reference product, which was first approved in 1998 in the US.

These are paediatric and adult Crohn’s disease in second line, adults with severe ulcerative colitis in second line, moderate-to-severe rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis and adult chronic severe plaque psoriasis.

The FDA decision follows a recommendation from its Arthritis Advisory Committee to approve the biosimilar in all the originator’s indications, by a vote of 21-3.

A decision on the biosimilar had been delayed by more than a year after the FDA asked for more information. A second Remicade biosimilar, Samsung Bioepis’ Flixabi, was recommended by Europe’s CHMP last week.

Related articles:

European regulators back Samsung’s Remicade biosimilar

Biosimilars could save US and EU $110 bn by 2020-report

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