The National Association of Chain Drug Stores, National Community Pharmacists Association and American Pharmacists Association (APhA), have made recommendations to the Food and Drug Administration aimed at facilitating the entry of lower-cost products into the biologic and specialty pharmaceutical markets.


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Rx groups call on FDA to ease entry of biosimilars

May 31st, 2012

ALEXANDRIA, Va. – The National Association of Chain Drug Stores, National Community Pharmacists Association and American Pharmacists Association (APhA), have made recommendations to the Food and Drug Administration aimed at facilitating the entry of lower-cost products into the biologic and specialty pharmaceutical markets.

The pharmacy organizations said Thursday have sent a joint letter with their suggestions to FDA as the agency works to finalize draft guidance on the development of biosimilar products, which are less-expensive versions of complex biologic medicines determined to be highly similar or interchangeable.

The FDA is readying to implement the Biologics Price Competition and Innovation Act, enacted as part of the Affordable Care Act health reform law.

"Pharmacists are the most accessible health care professionals, and recommending generic alternatives is a standard pharmacy practice," the groups noted in the 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."

In the letter, NACDS, NCPA and APhA submitted the following recommendations to the FDA:

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

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

• The FDA should provide further guidance on 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 — similar to the current Orange Book for generics — to aid health care providers in managing these prescription orders.

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

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