WASHINGTON, June 13, 2016 – On Monday, June 13, 2016, six groups representing a broad spectrum of biologic prescribers – Alliance for Patient Access, American Association of Clinical Endocrinologists, American College of Rheumatology, Biologics Prescribers Collaborative, Coalition of State Rheumatology Organizations, and Endocrine Society – 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), 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.
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 billion market 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.
The letter can be found below.
June 13, 2016
Dear Chairman Alexander and Ranking Member Murray:
Commending your bipartisan sponsorship of Section 11 of S. 2700, the undersigned organizations strongly support the provisions of S. 2700 (as amended) that assure full FDA authority over the identity (name) and quality standards for biologic products, including biosimilars. Absent this assurance, the unique regulatory framework Congress designed exclusively for the approval and safe use of biosimilars could be severely undermined.
Our nation’s biosimilar regulatory framework – as set forth in the Biologics Price Competition and Innovation Act (BPCIA) – accounts for the very significant differences between large-molecule biologics produced by living cells and small-molecule, chemically made drugs. Incompatible with these differences are the official compendia standards for identity and quality, which are configured for small-molecule drugs.
Section 11 will ensure official compendia standards are not applied to biologics, including biosimilars, thereby making explicit Congress’ intent when it passed BPCIA as part of the Patient Protection and Affordable Care Act in 2010.
Since then, FDA has worked to establish the appropriate regulatory framework for what is likely to be a $50-100 billion market in biosimilars.1 FDA has proceeded cautiously, declaring that it will make decisions on a case-by-case basis until it has the knowledge to impose a comprehensive regulatory framework for the approval and safe use of biosimilars.
Now, after considerable, specialized work and the approval of two biosimilars, the agency feels ready to propose, and soon finalize, guidance that will set the course for biosimilars. Potentially interfering with this biologics-based approach is the traditional, small-molecule drug role granted to official compendia, specifically that of the United States Pharmacopeia (USP), to define the official nomenclature and common quality standards.
This involvement of the USP has made sense for small molecule drug products. However, it is not appropriate for biosimilars, where each product relies on a unique cell line and manufacturing process and requires unique specifications. Section 11 will ensure that FDA sets biosimilars policy, not USP.
Along with many other stakeholders, we believe that Section 11 of S. 2700 is the right step to usher in the era of biosimilars. We thank you for introducing and actively supporting it.
Alliance for Patient Access
American Association of Clinical Endocrinologists
American College of Rheumatology
Biologics Prescribers Collaborative
Coalition of State Rheumatology Organizations
 Rader, R. A. (2013). An analysis of the US biosimilars development pipeline and likely market evolution. BioProcess Int, 11(6).