Comments on Competitive Biosimilar Marketplace Workshop
The United States Pharmacopeia (USP) says it supports efforts to foster access to biosimilars and to pursue initiatives that facilitate increased competition for biological products. Commenting on an FDA/Federal Trade Commission 3/9 workshop on a competitive marketplace for biosimilars, USP says its public quality standards “serve an important role in fostering a competitive marketplace for medicines.” The letter says the USP public standards for insulin have been used by manufacturers for decades to meet quality expectations.
Pharmaceutical Research and Manufacturers of America (PhRMA) says it “supports FDA’s efforts to implement a science-based regulatory approach in a timely manner that will ensure patient safety while facilitating a robust biosimilars market….” The association says it is critically important to ensure the long-term stability of the Biosimilar User Fee Act program through financial transparency, efficiency, and accountability. It says it supports many aspects of the FDA Biosimilar Action Plan, and particularly the need for physician education and experience with biosimilars to foster biosimilar uptake.
In its comment letter, Boehringer Ingelheim says it “applauds the agencies’ coordination in ensuring a competitive biologics and biosimilar marketplace in the U.S. Both agencies play equally critical roles in the future of this marketplace — FDA’s facilitation of access by driving efficient review of applications for biosimilar and interchangeable products, and FTC’s continued mission to ensure truthful and not misleading promotion of products as well as ensuring a fair and competitive landscape.”
In its letter, Lilly concentrated on the issue of rebate walls or traps that it says are engaged in by some manufacturers to foreclose competition from both biosimilars and lower-cost branded therapies. It says that rebate walls block competition by coupling volume-based discounts across multiple indications with retaliatory measures, such as the clawback of rebates by a market leader. “This contracting practice is especially problematic in the biosimilars market and the immunology market where established medicines control considerable market share,” Lilly says.
Finally, Janssen urges FDA and FTC to (1) take a patient-centric approach in policy decisions, prioritizing the patient-doctor relationship and supporting continuity of care; (2) ensure that interchangeability status is prominently disclosed, and (3) safeguard the competitive market dynamics that it says are dramatically bringing costs down.