Celltrion Inc. said the FDA’s Arthritis Advisory Committee recommended by a vote of 21-3 the approval of all requested indications for CT-P13, the first biosimilar monoclonal antibody to be considered by the FDA. CT-P13 is a proposed biosimilar to Janssen Biotech Inc.’s Remicade (infliximab), which the FDA approved in 1998. Janssen is a division of Johnson & Johnson.

Celltrion is seeking U.S. approval of CT-P13 as a treatment for Crohn's disease, ulcerative colitis, rheumatoid arthritis and other autoimmune diseases; the biosimilar is already approved in 67 countries. An FDA decision on the biologics license application for CT-P13 is expected in April.

If the agency approves the biosimilar, Pfizer Inc. will have commercialization rights in the United States under the proposed brand name Inflectra™. The FDA committee did not vote on the pediatric ulcerative colitis indication, as it is protected under orphan drug exclusivity until September 2018.

Leah Christl, an associate director with the FDA’s Office of New Drugs, said if CT-P13 is approved, it would be indicated for treatment-naïve patients or for a one-time switch from Remicade, but it would not be considered interchangeable with Remicade. She noted, however, that the FDA does not have authority to regulate payer substitutions.

Our Take: Remicade has about $6.5 billion in worldwide sales, of which $4.5 billion is in the U.S. Several sources, citing analysts, said the biosimilar could be priced at a 25% discount to Remicade. Other sources suggested that Janssen could lose half of its U.S. Remicade sales by 2020. 

The reality of that actually happening is less clear. J&J, AbbVie (Humira) and Amgen (Enbrel) have all filed late patents on their drugs that could protect them from biosimilar competition for years. As Morningstar reported, the patent litigation surrounding biosimilars is expensive and complicated, much more so than for traditional generics.

“Many of the newer patents cover drug-manufacturing processes and methods of using the drug to treat certain diseases, rather than the composition of the drug itself, which is covered by the original patents,” Morningstar said. The additional patents “could delay the entry of competing knockoffs well beyond when the FDA clears them for sale, and beyond the expirations of the branded drugs' original patents, which are due in coming months and years.”

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