FDA staff sounds encouraging note on Celltrion's biosim of J&J blockbuster Remicade
- During a meeting at the FDA, regulators responded positively to data for Celltrion's CT-P13, which is a biosimilar version of Johnson & Johnson's Remicade (infliximab).
- Remicade (infliximab) is a monoclonal antibody used to treat anti-inflammatory diseases and generated $4.45 billion in sales in 2015 for J&J. But sales are declining in the E.U. and Korea, where a biosimilar version of the drug is already available.
- If CT-P13 is approved, it will be the second approved biosimilar in the U.S. after Zarxio, a biosimilar of Amgen's Neupogen.
Celltrion has successfully demonstrated "no clinically meaningful differences" between its biosimilar version of Remicade and Johnson & Johnson's branded biologic, according to FDA staff. While Celltrion focused on two of the five indications for Remicade—rheumatoid arthritis and ankylosing spondylitis—it has also provided the FDA with information which can be used to extrapolate data to gain approval for the remaining indications.
Biosimilar Remicade was approved in the E.U. in 2013 as Remsima and subsequently launched in that market by Celltrion partner Hospira in early 2015. Johnson & Johnson has been feeling the pain on Remicade sales thanks to that biosimilar competition—but that pain could get a whole lot worse with a U.S. biosimilar approval.
But Remicade discounts may not be as steep in the U.S. as they are in other markets, where discounts can run as high as 30% to 50%. Zarxio, for instance, entered the American market at a relatively low 15% discount.