FDA Approves Infliximab Biosimilar

The United States Food and Drug Administration today announced the approval of infliximab-abda, a biosimilar to infliximab. The drug is called Renflexis and property of Samsung Bioepis, a collaboration between Biogen and Samsung Biologics. It has been approved for use in South Korea since 2015, where Merck handles its commercialization.

Infliximab (Remicade/Janssen) is a widely approved monoclonal antibody used in the treatment of a host of gastroenterological, rheumatoid, and dermatologic immune conditions. It has approvals for the treatment of Crohn’s disease and ulcerative colitis in both children and adults, as well as rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, and plaque psoriasis. A tumor necrosis factor alpha (TNF-a) inhibitor, it has also been studied for use against uveitis.

Infliximab received its first approval in 1998 for use against Crohn’s disease.

A year ago, another South Korean company, Celltrion, received FDA approval for their own infliximab biosimilar, infliximab-dyyb (Remsima). In August of last year, a court ruled against Janssen’s efforts to block that drug on patent grounds. That biosimilar, much like the new one from Samsung Bioepis, is also approved for all of the same treatments as Janssen’s original.

Also like the other biosimilar and the original infliximab, the injectable drug will carry the same box warning of a heightened risk of infection and malignancy, a common accompaniment for TNF inhibitors. The class of drug is effective because it can suppress the body’s inflammatory immune responses that lead to pain in conditions such as rheumatoid arthritis.

The announcement was first made on Twitter by the FDA earlier this afternoon:

FDA approves Renflexis (infliximab-abda), biosimilar to Remicade: https://t.co/SqQilAp1tJ. View PI @: https://t.co/CEooDrgPC0. pic.twitter.com/kor86cEpEy

— FDA Drug Information (@FDA_Drug_Info) April 21, 2017

For pediatric and adult Crohn’s disease, ulcerative colitis, psoriatic arthritis, and plaque psoriasis, the FDA’s recommended dosing regimens are the same: 5 mg/kg given as an intravenous induction regimen at 0, 2, and 6 weeks followed by a maintenance regimen of 5 mg/kg every 8 weeks thereafter.

For ankylosing spondylitis, a 5 mg/kg dose at 0, 2, and 6 weeks with a 5 mg/kg maintenance dose is also recommended, but the maintenance frequency is 6 weeks.

For rheumatoid arthritis, 3 mg/kg given as an intravenous induction regimen at 0, 2, and 6 weeks followed by a maintenance regimen of 3 mg/kg every 8 weeks is recommended. The drug is meant to be taken alongside methotrexate for RA patients, and the FDA writes that “for patients who have an incomplete response, consideration may be given to adjusting the dose up to 10 mg/kg or treating as often as every 4 weeks bearing in mind that risk of serious infections is increased at higher doses.”