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IFAA Clarification on Biosimilars Statement

Washington, DC, February 23, 2018 --( The International Foundation for Autoimmune & Autoinflammatory Arthritis (IFAA) applauds the FDA for developing patient and provider education materials on their website in order to promote a better understanding of biosimilars and interchangeable products. IFAA is thrilled that the FDA invited stakeholder feedback on the initiative, encouraging transparency, and enabling patient advocacy groups like IFAA to weigh in on this important project. Their enthusiasm, however, was overshadowed recently when a quote from IFAA was misinterpreted and taken out of context.

The original quote, “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,” was construed by some to mean that IFAA was questioning the safety and efficacy of biosimilars. Tiffany Westrich-Robertson, IFAA CEO responded, “We were disheartened to learn that the interpretation of our statement did not match our intent to emphasize the importance of having a reputable agency, such as the FDA facilitating education to equip patients with accurate information about safety and efficacy, which in turn, will help alleviate fears that may otherwise hinder biosimilar use.”

Westrich-Robertson added, “IFAA has a unique position in the community, as we are not only led by persons living with these diseases, but many of us – including myself – are also educators. When we learned that the FDA was welcoming input to enhance their patient education materials, we were honored to have the opportunity to be included.”

IFAA supports patient access to the most appropriate treatment options as determined by the patient and their healthcare provider, whether a biosimilar or reference biological product, and is committed to working with the FDA to ensure that relevant information is accurate, consumable, and readily accessible for patients and providers.

Learn more about IFAA’s position on biosimilars

IFAA works to eliminate the adversity associated with autoimmune and autoinflammatory diseases with arthritis as a major component. They use their roles as patients to identify the problems, and their backgrounds in education, business, and research – in conjunction with a global network of collaborators – to develop and implement solutions.
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Tiffany Westrich-Robertson

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