J&J drops suit against Remicade biosimilar maker
- Johnson & Johnson Services Inc.'s drug development unit Janssen Biotech Inc. has dropped a patent lawsuit against South Korean biotech Samsung Bioepis, according to a court filing dated Nov. 10.
- The lawsuit concerned Samsung’s biosimilar version of J&J's blockbuster rheumatoid arthritis drug Remicade, and the manufacturing process related to the drug.
- According to the court document, J&J voluntarily dismissed any claims related to alleged infringements of three patents, which referred to cell culture and downstream purification processes.
Court documents surfaced this week showing Janssen dropped its lawsuit against the South Korean biotech. In a statement to BioPharma Dive, Janssen said it brought the suit against Samsung Bioepis "to investigate whether their biosimilar infliximab infringes on our manufacturing process patents for Remicade," and after review of its abbreviated Biologics License Application and manufacturing information, J&J determined there was no cause for a suit.
Bioepis and its partner, Merck & Co., secured a green light from the Food and Drug Administration for Renflexis (infliximab-abda) in late-April of this year, the second approval for a biosimilar of Remicade (infliximab) in the U.S.
Pfizer Inc. and its partner Celltrion began shipping their Remicade biosimilar, Inflectra (infliximab-dyyb), at the end of October 2016.
So far, however, biosimilar competition has not cut into U.S. sales of Remicade in any significant way. The drug beat analysts' expectations by 6% in the third quarter, despite sales declining 1% in the U.S. and 8% overall. Revenues from the product totaled $1.65 billion over the three-month period.
Maintaining relatively stable sales in the U.S. is no small task, considering the drug faces two cheaper copycats as well as a number of newer drugs to treat rheumatoid arthritis. (Inflectra and Renflexis are priced at about a 20% and 35% discount, respectively, to Remicade on a list price basis.)
Stagnant sales have so frustrated Pfizer that the pharma sued J&J, accusing the multinational drugmaker of unfair marketing practices and restrictive contracting.
So far, lawsuits have actually been a major limiting factor to biosimilar adoption in the U.S. Most recently, AbbVie Inc. and Amgen agreed to a settlement outside of court regarding Amgen's biosimilar version of AbbVie's uber-blockbuster Humira (adalimumab). While terms of the agreement weren't readily disclosed, the settlement only allows for sales of Amgen's copy until next year in Europe and not until 2023 in the U.S.
The agreement also gave AbbVie rights to collect royalties on the Humira biosimilar.
While biosimilars took hold in Europe several years ago, they are still relatively new to the U.S. market. Physician awareness is still not at the same level as with generics and some remain hesitant to prescribe the knock-off biologics.
Convincing doctors may also be more difficult when biosimilars are priced at the 80% to 90% discounts typically seen in mature generic markets.
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