FDA Approves Celltrion’s Remicade Biosimilar

Celltrion’s Inflectra – a biosimilar to Janssen Biotech’s Remicade – is the second biosimilar to be approved by the US Food and Drug Administration (FDA). Inflectra is prescribed for most – but not all – of the same indications as Remicade.

The drug has been approved to treat some types of Crohn’s disease and ulcerative colitis, along with multiple forms of arthritis and psoriasis. The majority of these indications are limited to the most severe forms of disease in patients who have failed to respond to first-line therapies.

“Biosimilars can provide access to important treatment options for patients who need them,” said Dr. Janet Woodcock, 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.”

The regulatory agency requires that biosimilars demonstrate a high level of similarity to an already-approved biological product, referred to as the reference product. No clinically meaningful differences between the biosimilar and reference product are accepted by the FDA.

According to the FDA, the approval is based on extensive data demonstrating that Inflectra is indeed a biosimilar to Remicade. The agency reviewed data relating to the drug’s structure and function, along with safety and effectiveness information garnered from animal and human clinical trials.

Inflectra does carry a boxed warning denoting that patients taking the drug could face an increased risk of serious infections such as tuberculosis and bacterial sepsis. In addition, the agency will require physicians to dispense the product along with a Medication Guide to educate patients on potential risks and side effects.

Like Remicade, Inflectra is administered to the patient via an intravenous injection. Inflectra is manufactured by South Korea-based Celltrion for the American pharmaceutical company, Hospira. Inflectra has already received marketing authorization in other countries, including Canada and those in the EU.