Pfizer announced Inflectra, a biosimilar to Janssen’s Remicade, will ship to wholesalers in the United States in late November of this year, according to a press release. In response to the news, Janssen has released a statement.
“Biologics have revolutionized the treatment of many life-threatening and chronic diseases,” Diem Nguyen, regional president of the North America Pfizer Essential Health Business, said in the release. “By introducing Inflectra to the U.S. marketplace, Pfizer is helping customers access an additional high-quality treatment option that promises greater savings for the health care system.”
Inflectra (infliximab-dyyb, Celltrion) will become the first biosimilar monoclonal antibody to be made available in the United States and the second biosimilar available in the country, according to the release. The FDA approved Inflectra as a second-line treatment for Crohn’s disease and ulcerative colitis and as a first-line combination therapy with methotrexate for rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis and plaque psoriasis. According to the release, Inflectra will be introduced at a 15% discount to the current cost of Remicade.
In response to the news, Janssen has released a statement.
“We will continue to defend our intellectual property rights relating to our innovative medicines, and consider this commercial launch of the infliximab biosimilar to be an at-risk launch,” Andrew Greenspan, MD, vice president of medical affairs at Janssen Biotech Inc., said in the statement. “It is important to note that the infliximab biosimilar is not approved for interchangeability, which is a higher FDA standard. To be deemed interchangeable, a biosimilar must demonstrate it can be expected to produce the same clinical result as the innovator product in any given patient, and prove that the risk of alternating or switching between the products (in terms of safety or diminished efficacy) is no greater than the risk of using the innovator product without alternating or switching.”
In addition, Janssen will try to make Remicade more affordable.
“We intend to compete through a variety of innovative contracting options, discounts and rebates to payers, providers and pharmacy benefit managers to ensure Remicade remains an affordable option for patients and physicians,” Greenspan said. “We remain confident in the strength of our business.”