Celltrion will seek to grow its presence in the US after the FDA issued draft guidance regarding the interchangeability of biosimilars, Korea Bizwire reported Thursday.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