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Regulatory News | 30 January 2018 | By Zachary Brennan
The Association for Accessible Medicines' Biosimilars Council says Johnson & Johnson's (J&J) methods for blocking Pfizer's Remicade biosimilar could "serve as a blueprint for every brand name biologic drug maker seeking to maintain monopoly power and profits indefinitely in the face of competition from a lower-priced biosimilar," according to a brief submitted to the US District Court for the Eastern District of Pennsylvania.
At issue is a complaint filed by Pfizer last September arguing that its Remicade biosimilar, known as Inflectra (infliximab-dyyb), has gained just a tiny fraction of market share because of exclusionary contracts that J&J employs to stifle competition.
The Biosimilar Council's brief, which is in opposition to J&J's motion to dismiss Pfizer's complaint, explains how insurers have an economic incentive to accept the type of exclusionary contracts that J&J has used to maintain its dominance in the Remicade market despite these less-expensive biosimilar competitors on the market.
"J&J and other brand companies can leverage their patient bases for other products that enjoy strong brand loyalty by denying rebates to insurance companies for those products unless the insurers agree not to cover the relevant biosimilar," the Council says.
While noting the harm caused by J&J's exclusionary strategy on bringing down the prices of biologics for consumers even after enjoying its years of monopoly, the Council notes that it "is critical at this pivotal time for the fledgling biosimilars industry, and consistent with the overarching purposes of the BPCIA [Biologics Price Competition and Innovation Act], that incentives to develop and market biosimilars remain strong to improve patient access to more affordable prescription drugs."
The brief also notes that this case will be an important precedent to set, especially as Avalere Health has predicted that, "by 2025, seven blockbuster branded biologics that taken together account for 30% of U.S. biologic sales will all be outside the 12-year exclusivity window."
BRIEF OF THE BIOSIMILARS COUNCIL AS AMICUS CURIAE IN OPPOSITION TO DEFENDANTS' MOTION TO DISMISS