SEOUL, Jan 19 (Korea Bizwire) – The U.S. Food and Drug Administration (FDA) has released its draft guidance on biosimilar interchangeability, a move that will allow South Korean bio-pharmaceutical firm Celltrion Inc. to increase its presence in the U.S. market, company officials said Thursday.
The FDA unveiled the guidance Tuesday (local time) that recommends that bio-pharmaceutical firms seeking to get a biosimilar approved as interchangeable with its reference product conduct switching studies.
Biosimilars, such as Celltrion’s Remsima, have so far not been classified as an “interchangeable” product after being approved by the FDA for use in the United States.
The FDA’s decision will allow pharmacists to substitute a biosimilar without intervention from a manufacturer of a reference product, giving more options to U.S. patients, they said.
The draft guidance, which will be finalized in 60 days after a public hearing, will help Celltrion speed up exports of its Remsima, also known as Inflectra, company officials said.
Celltrion said its product will be judged as “interchangeable” with its reference biologic as its product has show the same clinical result.
“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,” said a Celltrion official asking not to be named
Remsima, is a biosimilar to Janssen Biotech, Inc.’s Remicade, effective for various diseases from rheumatoid arthritis to Crohn’s disease.