UPPER NYACK, N.Y.--(BUSINESS WIRE)--The Global Healthy Living Foundation, working with the Coalition of State Rheumatology Organizations (CRSO) and the Arthritis Foundation, in cooperation with the Congressional Arthritis Caucus, will host a congressional briefing titled, “Biosimilars for Arthritis Patients: Challenges and Opportunities” on Monday, July 13 from 12-1:00pm EDT at B340 Rayburn. Panelists will address the implementation of the Biologics Price Competition and Innovation Act (BPCIA), which was passed in 2010 as part of the Affordable Care Act, in light of the U.S. Food and Drug Administration (FDA) not providing final guidance on the approval of biosimilars and interchangeable biological products when it comes to naming, substitution, interchangeability and labeling.
“Arthritis, cancer, and other chronic disease patients who benefit from biologics have reason to look forward to biosimilars coming to market because they may represent new treatment options with the added benefit of yielding cost savings,“ said Louis Tharp, Executive Director of Global Healthy Living Foundation. “However, despite numerous stakeholders, including the Senate HELP Committee, requesting that the FDA finalize its protocol for reviewing, approving, and naming biosimilars, the final policy remains unseen with no opportunity for public comment. During the July 13 briefing, our diverse group of speakers will provide context and rationale for approving biosimilars under specific conditions that protect patient safety and promote transparency among the treatment team.”
Industry and Advocacy Come Together
Scheduled to speak and available for interview in advance of the briefing are:
- Dr. Harry Gewanter, Pediatric Rheumatologist, Pediatric & Adolescent HealthPartners; Clinical Associate Professor of Pediatrics, Virginia Commonwealth University School of Medicine
- Kim Greco, Director, Global Regulatory and R&D Policy, Amgen
- Katherine Macfarlane, Patient Advocate, Global Healthy Living Foundation
- TBD Sandoz (a Novartis Company)
- Dr. Gregory Schimizzi, Cofounder, Carolina Arthritis; Treasurer, Coalition of State Rheumatology Organizations
Biosimilars: Five Years in the Making
In March 2010, the BPCIA was signed into law as part of the Affordable Care Act (ACA). The law states that a biological product may be demonstrated to be “biosimilar” if data show that, among other things, the product is “highly similar” and interchangeable with an FDA-licensed product. In February 2012, FDA issued three draft guidance documents on biosimilar product development to assist the industry in developing them, but they have never been finalized.
Biosimilars, by definition and scientifically, are not the same as their parent biologic compound because they cannot be copied exactly, like a generic medication. The first biosimilar, Zarxio (filgrastim-sndz), was approved by the FDA in March 2015, but it is not yet commercially available. It was not approved as an interchangeable biosimilar, but, notably, it was given a distinct reference name. Several other biosimilars are under FDA review. Important to chronic disease patient communities is the need for unique, distinguishable names to ensure timely detection, assessment, and prevention of any adverse effects from a product. Patients, physicians and pharmacists need to be able to communicate effectively about what medications are being prescribed and taken.
About the Global Healthy Living Foundation:
The Global Healthy Living Foundation is a 501(c)(3) non-profit organization whose mission is to improve the quality of life for people living with chronic illnesses by advocating for improved access to care at the community, state, and federal levels, and amplifying education and awareness efforts within its social media framework. The Global Healthy Living Foundation is the parent organization of CreakyJoints, the online, non-profit, arthritis patient support community with more than 80,000 members and their families in all 50 states, Western Europe, South America and Australia, and the recently launched Arthritis Power, the first ever patient-led, patient-generated, patient-centered research registry for arthritis.