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First Monoclonal Antibody Submitted to EMA for Biosimilar Approval

Not surprisingly, a biosimilar version of Remicade® (infliximab) is the first regulatory application for a biosimilar monoclonal antibody (mAb) submitted to the EMA this month. Remicade®, marketed in the EU by Janssen Biotech (a subsidiary of Johnson and Johnson), is a mAb against tumor necrosis factor (TNF) alpha and is approved for a whopping 16 indications. While the name of the company submitting the application wasn’t disclosed by the EMA, it is widely acknowledged to be Celltrion’s submission.

Celltrion’s infliximab clinical trials were conducted with a total of 874 rheumatoid arthritis patients at 100 sites in 19 different countries throughout 2010 and 2011. It is unknown at this point if Celltrion is requesting approval for other indications in addition to rheumatoid arthritis as EMA Guidance allows for extrapolation of clinical efficacy and safety data to other indications for which the reference mAb has been approved. It is not necessary that these indications be specifically studied during the clinical development of the biosimilar as long as there is evidence of overall biosimilarity provided by the comparability exercise with adequate justification.

Approval from the EMA to extrapolate to multiple indications will be important for Celltrion to capture a meaningful portion of the $21 billion TNF-a antagonist market. While Remicade is forecasted to be one of the top three selling drugs in 2012, it was also one of the earliest mAbs to receive regulatory approval, and as a chimeric mAb (containing both human and murine sequences), it has some safety limitations associated with immunogenicity. Over the past decade, these older products are being supplanted with newer, humanized or fully human mAb versions such as Humira®. While biosimilar competition remains a concern, the verdict is still out as to whether Remicade’s $8 billion market is more likely to be cannibalized by biosimilars or by biobetter and next generation products, such as Janssen’s own Simponi product.

Now it is a waiting game for Celltrion as the earliest patents for Remicade do not expire until 2014 in the EU. However, Celltrion isn’t taking a ‘sit and wait’ approach – the company is preparing to file for Korean Food and Drug Administration approval this year. After that, the company plans to register their biosimilar infliximab product in emerging markets in Asia and Central/South America, where Remicade does not have patent protection.

While Celltrion was the first to file for approval of a biosimilar mAb, there are sure to be many more companies submitting biosimilar mAb applications in the near future. The first-mover advantage could be short-lived for Celltrion as more companies seek biosimilar market authorization, and branded products continue their strong market performance. This is further compounded by the fact that overall adoption of the early biosimilar products in Europe has not been as strong as anticipated or hoped even with price discounts up to 40% for some products from the branded product’s price. Samsung, clearly positioning itself to be a dominant player in the biosimilar market, predicts it will be a stronger overall competitor by selling its biosimilar portfolio at up to 50% off the innovator drug price. We believe that such price drops are achievable and will lead to significant gains in market share by Samsung and other biosimilar companies able to actually deliver on this promise. However, before steep price discounts can become a reality, products must be approved. So the questions remain – What hurdles will Celltrion face in the approval process? How easily will they be able to access other indications after approval? And of course, what kind of market penetration will Celltrion’s infliximab really achieve?


Blog article by: Patti Seymour