Premier Testifies During FDA Biological Products Marketplace Hearing

Premier testified during the Food and Drug Administration’s (FDA’s) public hearing to facilitate competition and innovation in the biological products marketplace on Sept. 4, 2018. Soumi Saha, PharmD, JD, Senior Director of Advocacy at Premier, provided comments on the FDA's approach to enhancing the biological products marketplace, including by facilitating greater availability of biosimilar and interchangeable products. The full testimony is below.

Food and Drug Administration Public Hearing: Facilitating Competition and Innovation in the Biological Products Marketplace

Docket No. FDA-2018-N-2689

Remarks By: Soumi Saha, PharmD, JD, Senior Director of Advocacy, Premier

Premier healthcare alliance thanks the FDA for the opportunity to provide comments on the FDA's approach to enhancing competition and innovation in the biological products marketplace, including by facilitating greater availability of biosimilar and interchangeable products. My name is Soumi Saha, and I am the Senior Director of Advocacy at Premier.

Premier is a leading healthcare improvement company, uniting an alliance of more than 4,000 U.S. hospitals and health systems and approximately 165,000 other providers and organizations to transform healthcare. With integrated data and analytics, collaboratives, supply chain solutions, and consulting and other services, Premier enables better care and outcomes at a lower cost. Premier plays a critical role in the rapidly evolving healthcare industry, collaborating with members to co-develop long-term innovations that reinvent and improve the way care is delivered to patients nationwide. A key component of our alliance is the Premier Pharmacy Program, which combines essential clinical data with purchasing power to deliver reduced costs, improved quality and safety and increased knowledge-sharing with other healthcare professionals.

Premier views the accessibility of biosimilars as a key element in creating a more competitive drug marketplace in the United States and has been a leader in promoting a competitive biosimilars marketplace through our supply chain, clinical support, education, advocacy, and thought leadership efforts. Premier currently has all marketed biosimilars on contract and employs a dedicated biosimilars team that works with biosimilars manufacturers through a product’s lifecycle, from pre- to post-launch, to ensure continued access to biosimilars. Clinically, Premier develops value analysis toolkits, provides product-specific information including clinical and financial considerations, and supports its members with reimbursement considerations for biosimilars within the Medicare and 340B programs. In regard to education, Premier maintains a dedicated website on biosimilars for health system pharmacy members that provides factual and un-biased information on biologics and biosimilars. In addition, Premier has developed several continuing education programs for health care providers on biosimilars and outreaches to health system stakeholders to educate and promote the adoption of biosimilars. From an advocacy perspective, Premier has been actively engaged in ongoing efforts with Congress, FDA, CMS, and other stakeholders to ensure that the pathway to market for biosimilars prioritizes patient access and safety and encourages development of these cost-saving medicines. Finally, Premier has authored several peer-reviewed journal articles, white papers, and blog posts discussing the current biosimilars landscape and encouraging adoption, and also serves on the Advisory Board for The Center for Biosimilars.

Premier applauds the FDA for recognizing the value of biosimilars and its important role in minimizing the time and cost to develop biosimilars and in promoting effective competition. Premier further applauds the FDA for releasing the Biosimilars Action Plan to outline the agencies approach to striking the appropriate balance between innovation, access, and competition for biosimilars. Premier offers the following comments on elements of the Biosimilars Action Plan that it believes can be enhanced to further promote a robust biosimilars marketplace.

To improve the efficiency of biosimilar and interchangeable product development and approval, as an overarching principle, FDA should permit a designation of biosimilarity parallel to granting an interchangeability designation if the applicant seeks both. The FDA has previously advised that applicants should seek designation of biosimilarity first and then subsequently seek interchangeability designation, a bifurcated process that creates procedural inefficiencies and potentially delays the introduction of interchangeable biosimilars to the marketplace. Therefore, Premier recommends that FDA create a parallel review process to permit applicants to seek a simultaneous designation of biosimilarity and interchangeability to create procedural efficiencies and improve access to interchangeable biosimilars.

To maximize scientific and regulatory clarity for biosimilar manufacturers, Premier supports FDA’s intent to improve regulatory predictability for manufacturers, harmonize international regulation of biosimilars and the acceptance of s non-US comparator products, and the use of real world evidence in supporting regulatory decision-making. One area to note, however, regarding harmonization and the acceptance of non-US comparator products, is that the FDA’s draft interchangeability guidance released in January 2017 states that use of a US-licensed reference product is required. Therefore, Premier urges the FDA to revise this requirement when issuing final interchangeability guidance to permit the use of non-US comparators when seeking interchangeability designation.

To improve the understanding of biosimilars, Premier agrees that it is critical to educate health care professionals and other stakeholders and applauds the FDA on their efforts thus far with the Biosimilar Education and Outreach Campaign, and the FDA’s commitment to creating additional innovative educational materials to explain biosimilars and interchangeability. As the FDA looks to develop these innovative educational materials, Premier suggests that FDA work with private partners who have already created these types of materials to adapt existing, factual, and un-biased educational materials to help speed the availability of these educational materials.

To support market competition, Premier agrees that it is necessary to reduce the gaming of FDA requirements or other attempts to unfairly delay competition. Premier offers two specific recommendations to help improve market competition:

• First, some manufacturers restrict access to samples for biosimilar manufacturers by citing compliance with limited distribution or REMS requirements. This practice inhibits the ability of biosimilar manufacturers to demonstrate bioequivalence and thereby delays the availability of biosimilars in the marketplace. The FDA has acted in this area by highlighting manufacturers they are aware of who are abusing REMS requirements to deny samples by listing these manufacturers on the FDA website, however more needs to be done to prevent these practices from occurring. Therefore, Premier recommends that FDA work with Congress to prevent access restrictions to product samples needed for bioequivalence testing for biosimilar development.
• Second, there has been an increase in patent disputes and settlements between biologic and biosimilar manufacturers delaying the availability of biosimilars in the marketplace beyond market-exclusivity granted under the BPCIA. Currently, this process is not transparent as biologic manufacturers do not have to report patent settlements to the Federal Trade Commission in the same manner that brand manufacturers must, a process that is considered a deterrent for brand manufacturers to enter into a patent settlement. Premier recommends that FDA work with Congress and the FTC to require biologic and biosimilar manufacturers to report patent settlements to the FTC.

Finally, one additional area not included in the Biosimilars Action Plan that Premier would like to raise is the naming convention for biosimilars. The current naming convention finalized by the FDA in January 2017 adds complexity to the healthcare system, which could lead to errors in prescribing medications and pose a risk to patients’ safety; hampers clinical decision making and the ability to identify lower-cost therapeutic alternatives; and causes unnecessary confusion among patients and providers – all issues that do not lend themselves to increasing the adoption of biosimilars. Premier urges the FDA to rescind the current naming guidance and reissue guidance that uses the same international non-proprietary name (INN) for biosimilars as the biologic reference product.

In summary, Premier encourages the FDA to:

• Permit a designation of biosimilarity parallel to an interchangeability designation, if the applicant seeks both;
• Harmonize international regulation of biosimilars and the acceptance of non-US comparator products, including for demonstration of interchangeability;
• Work with private partners to adapt existing, factual, and un-biased educational materials;
• Work with Congress and the Federal Trade Commission to address anticompetitive practices; and
• Revise the naming guidance to use the same INN for biosimilars as the reference product.

Again, I thank the FDA for the opportunity to provide these comments and I am happy to take any questions.