Celltrion to Expand Presence in US With FDA's New Guidance - (The Korea Bizwire via NewsPoints Desk)

  • Celltrion will seek to grow its presence in the US after the FDA issued draft guidance regarding the interchangeability of biosimilars, Korea Bizwire reported Thursday.

  • Under the guidance, the FDA recommends that company seeking to win approval of biosimilars as interchangeable with their reference products conduct switching studies. 

  • Once a biosimilar is deemed interchangeable, the FDA will permit pharmacists to substitute a biosimilar without intervention from the manufacturer of the reference product.

  • At present, biosimilars, including Celltrion's Remsima, a biosimilar of Johnson & Johnson's Remicade, are not considered interchangeable by the FDA.

  • "The FDA guidance will bring positive effect to the company's market share in the U.S., as Remsima will be administered to existing patients," a Celltrion official remarked.

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