The U.S. Food and Drug Administration issued a warning letter to Celltrion Inc., noting concern at the South Korean company's manufacturing plant in Incheon.
Pfizer Inc.'s Inflectra is produced at the plant which the regulator said had certain issues related to manufacturing processes. Celltrion said the letter will not impact its production of Inflectra and that it will issue a full response within 15 days.
Inflectra is a biosimilar version of Johnson & Johnson's Remicade, which is used to treat autoimmune diseases including Crohn's disease, rheumatoid arthritis and plaque psoriasis.
