Pharmacy groups submit recommendations to FDA as agency finalizes draft guidance for biosimilars

WASHINGTON — As the Food and Drug Administration works to finalize draft guidance related to the development of biosimilar products, pharmacy groups recently weighed in with recommendations to facilitate the entry of lower-cost products into the biologic and specialty pharmaceutical markets.

The FDA is working to implement the Biologics Price Competition and Innovation Act — which was enacted as part of the Affordable Care Act — and is "designed to create an approval pathway for biosimilar and interchangeable biological products while preserving the incentives that have fueled the development of these medicines."

The American Pharmacists Association, National Association of Chain Drug Stores and the National Community Pharmacists Association sent a joint letter to the FDA, requesting the agency to consider the following recommendations:

  • Biosimilar products should maintain the same name as their reference biologic counterparts to help prevent confusion. The use of suffixes should be avoided as well;

  • Pharmacists should be able to automatically substitute biosimilar products for their biologic reference product, assuming the FDA deems interchangeability between products;

  • The FDA should provide further guidance regarding whether biosimilar medicines will be determined to be interchangeable with their reference products, how pharmacists can assess appropriateness of substitution for individual patients, labeling provisions for manufacturers, and prescribing standards for physicians; and

  • An interchangeability reference list should be developed by the FDA, something similar to the current Orange Book for generics, to assist health care providers in managing these prescription orders.

“Pharmacists are the most accessible healthcare professionals and recommending generic alternatives is a standard pharmacy practice,” the APhA, NACDS and NCPA said in their letter to the FDA. “Allowing pharmacists to perform fully within their scope of practice by permitting automatic substitution of cost-effective biologic and specialty medications increases availability, thereby greatly benefitting the entire healthcare system and the patients it serves. Our organizations recognize the need for education and training of health care providers on biosimilars. Our organizations are willing to work with FDA and other stakeholders to help develop and provide education to pharmacists."

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- 4:19 PM says

Good article, interesting. ISR recently authored a report on what US Pharmacists think about several topics regarding Biosimilars, including pharmacy-level substitution. Most pharmacists did not have a very solid understanding of Biosimilars and many did not agree with Pharmacy-level substitution. For more, please visit:

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