FDA Reviewers Support Biosimilar of Remicade

If approved, treatment would be second biosimilar in U.S.

In a report issued ahead of a meeting scheduled for February 9, FDA staff members have supported a biosimilar version of Janssen Biotech’s best-selling arthritis drug Remicade (infliximab). The product, called CT-P13, was developed by a Korean company, Celltrion, in partnership with Pfizer. If approved by the FDA, CT-P13 would be the second biosimilar available in the U.S.

In their report, the reviewers noted that CT-P13 is “highly similar” to Remicade, aside from minor differences in clinically inactive components. They concluded that the clinical data supplied by Celltrion “would meet the requirement for a demonstration of ‘no clinically meaningful differences’ between CT-P13 and the U.S.-licensed reference product in terms of safety, purity, and potency in the indications studied.”

At the upcoming FDA meeting, the agency’s Arthritis Advisory Committee will consider whether to recommend approval of CT-P13 to treat rheumatoid arthritis (RA) and inflammatory bowel disorders, such as Crohn’s disease (CD).

In its biologics license application, Celltrion sought licensure of CTP13 for the same indications as Remicade, i.e., RA, CD, pediatric CD, ulcerative colitis (UC), pediatric UC, ankylosing spondylitis, psoriatic arthritis, and plaque psoriasis.

Infliximab is an immunoglobulin G1 (IgG1) kappa monoclonal antibody with a high affinity for both soluble and membrane-bound tumor necrosis factor (TNF)-alpha. It functions primarily by binding, neutralizing, and sequestering excess TNF-alpha produced at sites of inflammatory disease.

CT-P13 was developed as a lyophilized powder with the same strength, dosage form, and route of administration (100 mg in a 20-mL vial for intravenous infusion) for use in the treatment of the same indications as those approved for Remicade. The CT-P13 formulation has the same inactive ingredients as Remicade. Outside the U.S., CT-P13 is marketed under the trade names Inflectra and Remsima.

In 2010, the FDA was given the authority to approve biosimilar products, with the goal of reducing drug costs. Since then, the agency has cleared only one biosimilar for sale––Novartis’ copy of Neupogen (filgrastim, Amgen). Amgen, meanwhile, has applied to the FDA for approval of a biosimilar version of Humira (adalimumab, AbbVie).

Sources: FDA Brief; February 5, 2016; Reuters; February 5, 2016; and BloombergBusiness; February 5, 2016.