Six groups representing a broad spectrum of biologic prescribers are commending the bipartisan sponsorship of Section 11 of S. 2700, a provision of the 21st Century Cures Act that assures full U.S. Food and Drug Administration (FDA) authority over the identity (name) and quality standards for biologic products, including biosimilars.
The groups – Alliance for Patient Access, American Association of Clinical Endocrinologists, American College of Rheumatology, Biologics Prescribers Collaborative, Coalition of State Rheumatology Organizations, and Endocrine Society – on Monday sent a letter to Health, Education, Labor and Pensions (HELP) Committee Chairman Senator Lamar Alexander (R-TN) and Ranking Member Senator Patty Murray (D-WA).
In 2010, the Biologics Price Competition and Innovation Act (BPCIA), established a biosimilar regulatory framework, highlighting the need for a unique regulatory pathway due to the very significant differences between large-molecule biologics produced by living cells and small-molecule, chemically made drugs. Historically, the United States Pharmacopia (USP) has been responsible for the official nomenclature and common quality standards of small-molecule drugs, however due to complexity of large-molecule drugs, Section 11 would ensure FDA obtains the authority over biologics and biosimilars.
FDA has worked to establish the appropriate regulatory framework for what is likely to be a $50-100 billionmarket in biosimilars. FDA has proceeded cautiously, declaring that it will make decisions on a case-by-case basis until it has gained the experience needed to impose a comprehensive regulatory framework for the approval and safe use of biosimilars. Counteracting FDA’s efforts, applying USP’s compendium requirements to biologics and biosimilars may create patient access barriers by applying traditional standard requirements to innovative and complex medicines.
As such, the Biologics Prescribers Collaborative, along with the other stakeholder organizations support Section 11 of S. 2700, which reinforces FDA’s efforts to ensure a safe and robust biosimilar market and acknowledges the disparities between biologics and traditional drugs, both scientifically and legislatively. – USNewswire