FDA should provide better education about biosimilar drugs on the agency’s web site dedicated to biosimilars, a patient advocacy group said.
Patients for Biologics Safety & Access (PBSA), a national coalition of more than 20 patient advocacy organizations, recommended several changes to the site, in comments to FDA. The coalition includes the American Autoimmune Related Diseases Association, Arthritis Foundation, Crohn’s & Colitis Foundation of America, Hepatitis Foundation International, and several other groups.
“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, in a statement from he group. “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.”
PBSA is encouraging FDA to make the following changes to the biosimilars web site:
- 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 versus a biosimilar.
“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,” said Tiffany Westrich-Robertson, CEO and director of Patient Engagement at the International Foundation for Autoimmune & Autoinflammatory Arthritis (IFAA), and a PBSA member, in the statement.
“Biosimilars have an important role to play in increasing both the quality and affordability of treatment and healthcare in the United States,” said Juliana M. Reed, president of the Biosimilars Forum, in a statement. “There are more than 700 million patient days of data worldwide that demonstrates biosimilars are as safe and effective as their reference products. Europe has benefited from biosimilars for over 10 years, and biosimilars have lowered drug costs and increased patient access in over 80 countries. Key to the success of biosimilars is stakeholder education, since there is a great deal of incorrect or misleading information about biosimilars that is confusing to both patients and clinicians. The Forum supports the efforts by the FDA to help healthcare providers gain a better understanding of these important products and the approval process they undergo, and plans to continue our work in this area with multiple stakeholders.”
The Global Healthy Living Foundation, and its arthritis community, CreakyJoints, which represents people with arthritis, said that it disagrees with the Patients for Biologics Safety & Access for chiding the FDA for its efforts to educate providers about biosimilars.
“Publicly admonishing the FDA over biosimilar issues that do not affect patient safety or efficacy, and do not focus on lowering drug costs for patients," said GHLF Executive Director Louis Tharp.
This article was updated on February 21, 2018.