The American Pharmacists Association (APhA), National Association of Chain Drug Stores (NACDS) and the National Community Pharmacists Association (NCPA) recently weighed in with the Food and Drug Administration (FDA) with recommendations to facilitate the entry of lower-cost products into the biologic and specialty pharmaceutical markets.
The pharmacy organizations have sent a joint letter to FDA as the agency works to finalize draft guidance related to the development of biosimilar products – less-expensive versions of complex biologic medicines that are determined to be highly similar or interchangeable. The FDA is working to implement the Biologics Price Competition and Innovation Act, which was enacted as part of the Affordable Care Act (P.L. 111-138).
“Pharmacists are the most accessible healthcare professionals and recommending generic alternatives is a standard pharmacy practice,” the groups said in their letter to 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 health care system and the patients it serves.”
The joint letter offered the following recommendations for the FDA to consider:
- 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.
- 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.
“Our organizations recognize the need for education and training of healthcare providers on biosimilars,” APhA, NACDS and NCPA added in their letter. “Our organizations are willing to work with FDA and other stakeholders to help develop and provide education to pharmacists.”