Patient Groups Call on FDA to Provide More Complete and Robust Biosimilars Educational Materials for Prescribers

National Coalition Offers FDA More Collaboration on Biosimilars Educational Effort

WASHINGTON, DC – February 15, 2018 – Patients for Biologics Safety & Access (PBSA), a national coalition of more than 20 patient advocacy organizations, today announced that it has submitted comments to the U.S. Food and Drug Administration (FDA) recommending changes to their online educational effort on biosimilars targeted to prescriber audiences. In October 2017, the FDA launched a new section on their main FDA.gov website dedicated to biosimilars.

“The FDA plays a critical role in educating stakeholders and the public about biosimilars and has made a much needed start with its introduction of educational materials for prescribers,” said Larry LaMotte, Vice President of Public Policy at the Immune Deficiency Foundation and lead coordinator of PBSA. “PBSA believes that our suggested changes will help provide more complete and robust policy and clinical elements and better assure that prescribers can effectively talk to their patients about the complex world of biosimilars.”

The current FDA Biosimilars website includes information about how biosimilars are developed, reviewed, approved and how they are prescribed. In addition, the website has educational materials, including online courses, webinars, and presentations. Among their recommendations, PBSA encourages the FDA to:

  • More clearly define and differentiate biosimilars and biologics;
  • Define key terms like bioequivalence, approval process, and similarity throughout the website;
  • Provide more examples in plain language of meaning of terms in the biosimilar process;
  • Provide more information on the FDA approval processes for biosimilars and interchangeable products;
  • Emphasize the importance of the patient-doctor relationship as it relates to prescribing a biologic vs. a biosimilar.

“PBSA looks forward to working with the FDA as they continue to develop educational resources for prescriber and patient communities,” said Tiffany Westrich-Robertson, CEO and Director of Patient Engagement at the International Foundation for Autoimmune & Autoinflammatory Arthritis (IFAA) and PBSA member. “As more biosimilars come to market, we need to make sure we’re educating consumers, especially those managing autoimmune diseases, about the safety and efficacy of these products.”

If you have any questions, please contact Larry LaMotte, Vice President, Public Policy at the Immune Deficiency Foundation (IDF) llamotte@primaryimmune.org or 443-632-2552.

About Patients for Biologics Safety & Access

Patients for Biologics Safety & Access (PBSA) brings together a variety of patient advocacy groups with a common interest in ensuring that patients have access to safe and effective biologic medicines.

Members include: American Autoimmune Related Diseases Association, Arthritis Foundation, Committee of Ten Thousand, Crohn’s & Colitis Foundation of America, Dystonia Medical Research Foundation, GBS/CIDP Foundation International, Hemophilia Federation of America, Hepatitis Foundation International, Immune Deficiency Foundation, International Foundation for Autoimmune & Autoinflammatory Arthritis, Jeffrey Modell Foundation, Lupus and Allied Diseases Association, Lupus Foundation of America, National Alliance on Mental Illness, National Organization for Rare Disorders, National Psoriasis Foundation, Platelet Disorder Support Association, Pulmonary Hypertension Association, RetireSafe, Scleroderma Foundation, Spondylitis Association of America, United Spinal Association, US Hereditary Angioedema Association, U.S. Pain Foundation. For more information, visit www.BiosimSafety.org or @BiosimSafety on Twitter.

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