This week, the FDA released a Form 483 noting observations made when inspecting Celltrion’s manufacturing facility in May and June 2017. The heavily redacted form notes 12 observations.
This week, the FDA released a Form 483 noting observations made when inspecting Celltrion’s manufacturing facility in May and June 2017.
The heavily redacted form notes 12 observations:
Some analysts have suggested that the FDA’s observations could explain the slow uptake of Celltrion and Pfizer’s infliximab biosimilar, Inflectra, in the United States. Speaking with the Regulatory Affairs Professionals Society, biotechnology analyst Ronny Gal said that problems noted in the form could be why Pfizer “did not push Inflectra more broadly. Now with competitor [Samsung Bioepis and Merck] launching [Renflexis], the latter has an advantage.”
Celltrion and Pfizer’s Inflectra, which launched at a 15% discount to the list price of the reference Remicade, has only gained a 2% market share for infliximab. Pfizer has recently adjusted its average sales price for the drug in an effort to be more competitive with the originator product.
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