Pfizer’s Remicade Biosimilar Gets FDA Go-Ahead

US pharmaceutical giant Pfizer has received regulatory approval for its second biosimilar to Johnson & Johnson’s Remicade, but the company says it has no plans to commercialize the drug in the near future. Ixifi was solely developed by Pfizer prior to its acquisition of Hospira in 2015 when it acquired the first Remicade biosimilar to market, Inflectra, which was co-developed by Celltrion.

In addition to Inflectra and Ixifi, a third biosimilar version of Remicade, Samsung Bioepis’ Renflexis, has been approved for all eligible indications of the reference product. The antibody drug is approved to treat rheumatoid arthritis, Crohn’s disease and ulcerative colitis, among other autoimmune diseases.

While it’s unclear why Pfizer would pursue FDA approval for a product it doesn’t intend to launch, it’s likely they have a good reason for getting the biosimilar passed. According to Regulatory Focus, Pfizer could chose to commercialize Ixifi in countries where the company’s Inflectra biosimilar was never launched.

While biosimilars of Remicade are priced lower than the branded biologic, sales of Inflectra have failed to take much of Johnson & Johnson’s market share. Pfizer has sought interchangeability status with Remicade from the FDA in an attempt to boost sales, however the regulator has yet to grant that to any biosimilar manufacturer.

In September, Pfizer filed a lawsuit against Johnson & Johnson over the company’s exclusionary contracts with payors preventing them from covering the biosimilar. Despite competition from two biosimilars, Remicade has retained 96 percent market share, bringing in $1.65 billion in global sales in the third quarter of 2017.