FDAnews Drug Daily Bulletin
Pharmaceuticals / Regulatory Affairs

AAM: Exclusionary Biologics Contracts Will Hurt Emerging Biosimilars Market

Feb. 5, 2018

The Association for Accessible Medicines’ Biosimilars Council submitted an amicus brief supporting Pfizer in its antitrust lawsuit against Johnson & Johnson, arguing the company’s practices will keep biologics prices high and limit competition from biosimilars.

Pfizer sued J&J last September arguing its exclusionary contracts and rebate arrangements with insurers and hospitals block sales of biosimilars for its blockbuster immunosuppressive drug Remicade. These policies, the lawsuit claimed, have kept Pfizer from competing for at least 70 percent of insured patients even though Inflectra, its Remicade biosimilar, carries a lower list price.

In its amicus brief, filed against a J&J motion to dismiss the suit, the Biosimilar Council notes that biosimilars have only recently begun to gain momentum since a series of 2015 FDA guidances and anticompetitive practices such as J&J’s will hurt this progress.

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