Celltrion Extends Remsima SC Indications

Subcutaneous Infliximab Gets Nod Covering IBD And Ankylosing Spondylitis

29 Jun 2020

Celltrion has received a positive opinion from the CHMP for five additional indications for its Remsima SC biosimilar, expanding the scope of the subcutaneous infliximab product that was launched earlier this year.

Voting — The EMA’s CHMP has endorsed the indications across Europe • Source: Shutterstock

Celltrion will be able to expand the scope of treatment for its innovative subcutaneous formulation of biosimilar infliximab after the European Medicines Agency’s Committee for Medicinal Products for Human Use issued a positive opinion recommending an additional five indications for Remsima SC, including for use in inflammatory bowel disease and ankylosing spondylitis.

The European Commission typically acts to convert CHMP recommendations into formal approvals within 67 days.