The FDA on Tuesday, in its press release, approved Inflectra, a first biosimilar monocolonal antibody, made by Hospira, for multiple indications. This is the second time FDA has ever approved another biosimilar drug. The first one was from Sandoz. Inflectra will be used for the treatment of rheumatic disease, rheumatoid arthritis and psoriatic arthritis.
Biosimilar Treatment For Rheumatoid Arthritis
Inflectra is a biosimilar to Janssen Biotech, Inc.’s ‘Remicade’ (infliximab), which was originally licensed in 1998. “Biosimilars can provide access to important treatment options for patients who need them,” said Janet Woodcock, M.D., Director of FDA’s Center for Drug Evaluation and Research. “Patients and the health care community can be confident that biosimilar products are high quality and meet the agency’s rigorous scientific standards.”
Health care professionals are advised to review the prescribing information for detailed information about the approved uses.
Biosimilars were allowed to be produced under ‘Biologics Price Competition and Innovation Act’ of 2009 (BPCI Act), signed by Obama in 2010 into a law. This act was passed as part of the Affordable Care Act. This act allows the ‘reference product’ to have licensure pathway to get biological products called as biosimilars and interchangeables. The section 351 (k) of this act controls the quality of the product by compelling the companies to give specific pre-clinical and clinical data similar to the reference product. The BPCI Act was passed to cut down the resources for R&D. A new analysis finds that United States will save $44 billion over the next decade.
A biosimilar product can only be approved by FDA. It is a biological product that is approved on the basis of its similarity to an already approved reference product. The biosimilar must also demonstrate that it has no significant differences in terms of safety, purity, potency and effectiveness from the reference product. Only minor differences in clinically inactive components are allowable in biosimilar products. Inflectra has undergone all the standardized rules of FDA to get an approval.
American College of Rheumatology (ACR) has applauded the decision because it will outnumber the access of patients to life changing therapies.
Inflectra can be prescribed by a health care professional for treating patients with moderate to severe Crohn’s disease and ulcerative colitis which respond inadequately to the conventional therapy. It can also be used in patients with rheumatoid arthritis in combination with methotrexate and in patients with active ankylosing spondylitis (arthritis of the spine), psoriatic arthritis and chronic severe plaque psoriasis. Inflectra is administered as an intravenous infusion. However, the side effects can be mainly respiratory infections and the infusion reactions that can occur two hours after the administration.
All newly approved prescription drug products, including biosimilars, must follow the general labeling regulations approved in 2006 and updated in 2014 by FDA. For biosimilar labels the biosimilarity statement should be added with the label.