STAKEHOLDERS CALL FOR CLARITY ON BIOSIMILAR POLICY ISSUES
Global Healthy Living Foundation Supports the Issuing of Additional FDA Guidance on Biosimilars
(Upper Nyack, NY) Yesterday, 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, co-hosted a congressional briefing to address the forthcoming availability of biosimilars 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. Following lively presentations from speakers representing patient advocacy groups, professional physician groups and the pharmaceutical industry, the panel recommended unanimously that FDA provide greater clarity on biosimilars by finalizing the much needed guidance documents.
“Chronic disease patients – those with arthritis, cancer, MS and many other conditions – who benefit from biologics are eager to add biosimilars to the arsenal of treatment options, particularly if anticipated cost reductions trickle down to their wallets. But five years after the Biologics Price Competition and Innovation Act (BPCIA) was enacted as part of the Affordable Care Act, patients, physicians and industry still wait for the U.S. Food and Drug Administration to specifically define how biosimilars will be evaluated and named,” said Louis Tharp, Executive Director of Global Healthy Living Foundation. “As we heard in today’s briefing our hope is that the Senate HELP committee or House Energy and Commerce committee will schedule a hearing to provide FDA the platform to share their perspective on why some of the most fundamental policy questions under the BPCIA remain unanswered.”
Diverse Speakers Advocate Together for FDA Guidance
Open to the public and also targeting Congress and congressional staff, the briefing, titled ““Biosimilars for Arthritis Patients: Challenges and Opportunities,” featured five panelists including:
- 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
- Jim McKay, PhD, Director, Clinical Development and Medical Affairs Sandoz Biopharmaceuticals (a Novartis Company)
- Gregory Schimizzi, Cofounder, Carolina Arthritis; Treasurer, Coalition of State Rheumatology Organizations
Panelists reviewed the importance of biologics and biosimilars for patients dealing with many diseases including rheumatoid arthritis. Katherine Macfarlane shared the success she’s had using biological products to treat her rheumatoid arthritis noting, however, that patients develop resistance to these medications. Therefore, eventually, she will be required to switch to a new treatment. Her hope lies in the development of biosimilars to significantly increase the number of treatment options that she will have available to her over her lifetime. Jim McKay of Sandoz and Kim Greco of Amgen relayed the pros and cons of various stances FDA could take on naming, substitution, interchangeability, and labeling of biosimilars emphasizing that clear regulatory frameworks are needed to encourage companies to continue investing in these expensive products. Drs. Harry Gewanter and Gregory Schimizzi shared their perspectives on the importance of tracking patient response to medications. Schimizzi noted that decisions about naming and interchangeability made on the federal level will ultimately affect how states dispense medications and how doctors will be able to track which medication a patient responds poorly to. Panelists had all eyes on FDA hoping that decisions will be made sooner than later so that next steps can be taken to fully incorporate biosimilars as viable options for patients like Macfarlane.
“Our organization always puts the needs of patients first and what was particularly impactful during the meeting was to see how industry, physicians, and patients can come together to educate external audiences about the potential of biosimilars,” added Tharp. “Biosimilars have been on the market in Europe for approximately five years. European patients have benefited dramatically from their expanded access and cost savings. As a world leader in health care, surely we can do better than a five year delay in making these products available to Americans.”
The Potential of Biosimilars
A biologic medicine is a large molecule typically made from living cells and used in the treatment, diagnosis or prevention of disease. Biologic medicines include therapeutic proteins, DNA vaccines, monoclonal antibodies and fusion proteins, and are often 200 to 1,000 times the size of widely used small molecule drugs and are far more complex structurally. They are also highly sensitive, making them more difficult to characterize and produce.
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.
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