Remsima is the first biosimilar the Kosdaq-listed Celltrion has developed and commercialized. Raymond said more than 60 other anti-TNF biosimilars are in development and could commoditize the drug class much sooner than thought. Humira already competes with Remicade for patients, and a cheaper version would be bad news for its sales prospects.
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By a 21-3 vote, the advisory committee favored approval of the biosimilar of Johnson & Johnson’s Remicade – a move that could threaten sales of the branded Remicade drug. Remicade is J&J’s top seller – reaching $6.5 billion in sales a year ago – and is one of the best-selling drugs in the world.
J&J told Biopharma-Reporter it did not agree with data extrapolation, citing Celltrion’s biosimilar’s minor differences in clinically inactive components.
The follow-on biologic, known as CT-P13, would be the second biosimilar cleared for marketing in the United States after Sandoz’s Zarxio (filgrastim) was approved last March.
The FDA panel of outside experts agreed that Celltrion’s version of the drug was highly similar to original Remicade, the standard set by the FDA for approval.
Two big unanswered questionsThe introduction of biosimilars raises two big questions that we really don’t have the answers to yet. CT-P13 was licensed by the European Commission in September 2013 as Remsima/Inflectra for all indications of its reference product, Remicade, including moderately to severely active adult and pediatric Crohn’s disease (CD), moderately to severely active adult and pediatric ulcerative colitis (UC), moderately to severely active rheumatoid arthritis (RA), severe active ankylosing spondylitis (AS), active psoriatic arthritis (PsA), and moderate to severe plaque psoriasis (PsO). Merck in its year-end earnings reported Remicade sales were $1.79 billion, down 10% on an exchange-adjusted basis for the year.
“The biggest potential damage could be to J&J, which has US rights to Remicade”, said Conover. Many believe that this week’s vote signals the FDA’s willingness to adopt more lenient criteria for biosimilars, which could have a detrimental effect on biotechs’ bottom lines.
Infliximab is a treatment for many autoimmune diseases, with more than 18 years of clinical data and experience since its FDA approval in U.S.in 1998. “I have someone in my office who’s tracking 250 different patents or patent applications for Humira”, Denny Lanfear, chief executive of biosimilar developer Coherus BioSciences Inc., said at an investor conference in January. They also would “lose their rebates if they prefer the biosimilar for part of the market”, Gal said.
The patent litigation surrounding biosimilars is likely to be costly and complicated.
Companies like Johnson & Johnson that develop drugs to treat specialized diseases typically take out a wide variety of patents in order to protect their interests and keep other companies from introducing generic versions.
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Jeanne Whalen contributed to this article.
