Biosimilars Council Backs Pfizer With Amicus Brief in Ongoing Infliximab Case

On January 26, the Biosimilars Council (a division of the Association for Accessible Medicines) filed an amicus brief opposing Johnson & Johnson’s motion to dismiss a complaint brought by Pfizer over its biosimilar infliximab, Inflectra, which references Johnson & Johnson’s innovator product, Remicade.

Pfizer alleged in its lawsuit, filed in the Eastern District of Pennsylvania in September 2017, that Johnson & Johnson has engaged in exclusionary contracting and anti-competitive practices that have effectively denied patients access to biosimilar therapies. Pfizer’s complaint says that the Remicade maker threatened to withhold rebates from both insurers and physicians unless they agreed to exclude biosimilars from formularies or impose fail-first preconditions for biosimilars (an arrangement sometimes referred to as a “rebate trap”). At the same time, according to the complaint, Johnson & Johnson raised Remicade’s price.

In its amicus brief supporting Pfizer’s position, the Biosimilars Council claims that Johnson & Johnson’s attempts to keep its market share of the blockbuster reference product were intended to “prevent Inflectra from competing” with Remicade. It also argues that, if the court sides with Johnson & Johnson, it would effectively provide a roadmap for other innovator product sponsors to follow suit in quashing biosimilar competition for high-cost biologics.

The brief lays out 5 key points:

• There is a need for competition in the market for biologics
• Congress sought to facilitate price competition through the Biologics Price Competition and Innovation Act (BPCIA)
• Biosimilars have the potential to produce savings and increase patient access
• Biosimilars are costly to develop and market
• The market for biosimilars is in its infancy, and incentives to produce biosimilars must be protected and reinforced

The brief also argues that, as a result of Johnson & Johnson’s strategies, Inflectra’s market share has remained artificially small at a mere 4% of the infliximab market, which will deliver a low return on investment and diminish economic incentives needed to spur greater biosimilar development.

“Replication of these tactics across biologics markets will dramatically diminish incentives for developing future biosimilars, and competition in this critical, growing sector of the healthcare industry will suffer,” writes the Biosimilars Council. “In short, this case will help define the scope of antitrust protections for biosimilars for years to come and determine the viability of the industry that Congress sought to create through the BPCIA.”