The FDA has approved Celltrion’s infliximab-dyyb, a biosimilar to infliximab, for multiple indications, including rheumatoid arthritis in combination with methotrexate, ankylosing spondylitis, psoriatic arthritis, plaque psoriasis, Crohn’s disease in adults and children older than 6 years, and patients with moderate to severe ulcerative colitis who inadequately responded to conventional treatment.
Infliximab-dyyb (Inflectra, Celltrion) is the second biosimilar to be approved in the United States, and the first biosimilar to infliximab (Remicade, Janssen).
“Biosimilars can provide access to important treatment options for patients who need them,” Janet Woodcock, MD, director of the FDA’s Center for Drug Evaluation and Research, said in the FDA announcement. “Patients and the health care community can be confident that biosimilar products are high quality and meet the agency’s rigorous scientific standards.”
The decision is based on data from a review of evidence of functional and structural data, animal studies, human pharmacodynamics, pharmacokinetics and immunogenicity investigational data, and clinical safety and efficacy data from approved studies.
“As one of the first companies to navigate the biosimilar approval pathway with the FDA, we believe this approval will be an essential step in helping to clarify the application process for these critical medicines,” HyoungKi Kim, chief executive officer of Celltrion, said in a press release from the company. “Our experience with biosimilars outside the [United States] U.S. suggests that Inflectra provides patients with both therapeutic and financial benefits, and we hope to see the same value provided in the U.S.”
Some researchers agree.
“The FDA approval of Inflectra, just the second biosimilar to be approved in the U.S., is significant for the medical community as this therapy has conclusively demonstrated comparable safety and efficacy to the reference product, and will provide the medical community with an alternative, more affordable treatment option,” Vibeke Strand, MD, adjunct clinical professor in the Division of Immunology/Rheumatology at Stanford University School of Medicine and researcher, said in a press release. “This approval will help to remove barriers for the many health care professionals and their patients where cost and access to treatment for these chronic autoimmune diseases has been a challenge.”
The Biologics Price Competition Act of 2009 was passed as part of the Affordable Care Act and allows an abbreviated licensure pathway for large molecule biologic medications that are biosimilar to existing biologics to create market competition after demonstrating biosimilarity to the reference product. Infliximab-dyyb has been designated as biosimilar to, but not interchangeable with, the originator infliximab.
A representative from Janssen’s parent company, Johnson & Johnson, responded to the news.
“Celltrion’s infliximab-dyyb is a biosimilar, but not identical to Remicade,” Jay Siegel, MD, chief biotechnology officer and head, Scientific Strategy and Policy at Johnson & Johnson, said in a statement emailed to Healio.com/Rheumatology. “It is important to note that the FDA has not approved Celltrion’s infliximab-dyyb as being interchangeable with Remicade. For FDA to determine a biosimilar is interchangeable with its reference product, a manufacturer must demonstrate that the biosimilar is expected to produce the same clinical result as the reference product in any given patient. In addition, the manufacturer must demonstrate the risk of alternating or switching between the reference product and biosimilar is no greater than the risk of using the reference product.”
Additional background information in the statement noted patents for Remicade remain valid until September 2018 and that the company intends to “defend our intellectual property rights.”