Last month, I presented at the U.S. Food and Drug Administration’s (FDA) Public Hearing on Facilitating Competition and Innovation in the Biological Products Marketplace. The hearing was part of an ongoing dialogue with health care stakeholders and the FDA on the Agency’s efforts to promote innovation and competition in the biologics marketplace. PhRMA is dedicated to helping achieve that balance, which is reflected in our comments on the Biosimilars Action Plan and other related topics submitted to the Agency.
If implemented, the Biosimilars Action Plan would foster scientifically rigorous policies that would increase public confidence in biosimilars and help bring these medicines to patients. As part of my presentation last month and our written comments, I highlighted several key areas.
I touched on the importance of applying umbrella exclusivity for biologics, just as the FDA does for small molecules. Importantly, an umbrella policy would not extend exclusivity for any new product or use beyond the original period. Instead, a supplement or new application for a biologic that has been approved will be subject to any remaining portion of the same 12-year exclusivity period applicable to the original product. Application of umbrella exclusivity prevents the illogical result of allowing a biosimilar applicant to immediately obtain approval for a changed product or new use, even before it could obtain approval of a biosimilar of the original reference product.
We support the FDA’s application of this policy to biologics to incentivize the necessary R&D investment needed to maintain continued innovation in biologics.
I also provided feedback on the FDA’s efforts to develop its policy for implementing the transition provisions of the Biologics Price Competition and Innovation Act. Starting in March 2020, new drug applications (NDAs) for products meeting the definition of biologic products will be deemed approved biologics license applications (BLAs). I reiterated concerns we have about the impact FDA’s proposed policy could have for transitioning NDAs with unexpired Hatch-Waxman and pediatric exclusivity. We suggest the FDA allow granted exclusivity to remain in place and the Hatch-Waxman patent provisions to apply to transitioning products through the term of the last-expiring Orange Book-listed patent for a medicine.
At the same time, we propose that sponsors of transitional NDAs or supplements that are pending on March 23, 2020, should be allowed to retain their status until final approval, when they will be deemed BLAs, BLA supplements or biosimilar applications. This approach would streamline the transition and avoid necessitating withdrawal and resubmission of existing applications or supplements as BLAs.
Another important element of the Biosimilars Action Plan I commented on is the FDA’s proposed use of data-sharing agreements to expedite drug and biologic development, including biosimilars. We support appropriate data-sharing agreements that facilitate cooperation between regulators in different jurisdictions. PhRMA also supports the FDA’s adoption of analogous bridging study standards when non-U.S.-licensed comparators are used in development programs for reference products and for biosimilar products. However, we are concerned by suggestions that FDA could waive bridging study requirements solely on the basis of non-public information about the relationships between non-U.S.-licensed comparators and reference products.
Finally, PhRMA provided input on how we can make meaningful enhancements to the Purple Book in order to provide clearer information to all stakeholders and voiced our support of the FDA’s ongoing education efforts in order to support a viable biosimilars market.
As America’s health care system continues to evolve, biosimilars will play an increasingly critical role in bringing new options to patients and decreasing prescription drug spending. Recent studies project that biosimilars could reduce spending on biologics by $25 billion to $150 billion over the next 10 years. PhRMA commends the FDA on its dedication to improving competition and encouraging innovation in the biologics market and looks forward to continuing to work with the FDA on science-based regulations that ensure patient safety.
David Korn David Korn is Vice President, Intellectual Property (IP) and Law, for the Pharmaceutical Research and Manufacturers of America (PhRMA). He focuses on IP issues in Congress, the Patent and Trademark Office and other agencies, as well as in amicus briefs in cases of interest to PhRMA. He has degrees in biomedical engineering from Duke and Northwestern and a J.D. from Harvard Law School. Prior to joining PhRMA, he worked in private practice and clerked in the U.S. District Court for the District of Delaware.