Pharmacy groups advise FDA on maximizing benefits of biosimilars

May 31, 2012

Three major pharmacy associations have sent recommendations to FDA for maximizing the health benefit and costs savings of generic biologic products.

Three major pharmacy associations have sent recommendations to FDA for maximizing the health benefit and costs savings of biosimilars.

The American Pharmacists Association, National Association of Chain Drug Stores, and the National Community Pharmacists Association sent a joint letter to FDA as the agency works to finalize draft guidance related to the development of biosimilars.

FDA is working on the Biologics Price Competition and Innovation Act, which was enacted as part of the Affordable Care Act.

“Pharmacists are the most accessible healthcare professionals and recommending generic alternatives is a standard pharmacy practice,” the groups said in their letter. “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 letter offered the following recommendations:

• Biosimilar products should maintain the same name as their reference biologic counterparts to help prevent confusion.

• Pharmacists should be able to substitute biosimilar products for their biologic reference product, if FDA deems interchangeability between products.

• FDA should provide more 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 FDA to assist health care providers in managing these prescription orders.

"Our organizations recognize the need for education and training of health care providers on biosimilars,” the associations added in the letter. “Our organizations are willing to work with FDA and other stakeholders to help develop and provide education to pharmacists.”