Pharmacy Times (03/08/16) Ross, Meghan

Participants at the recent at the American Pharmacists Association 2016 Annual Meeting & Exposition heard about several advances in the biosimilar field. Edward C. Li, of the University of New England College of Pharmacy, and James G. Stevenson, of the University of Michigan College of Pharmacy, highlighted several points that pharmacists should know about biosimilars. They noted that it has been a year since the first and only biosimilar was approved in the United States, but the Food and Drug Administration (FDA) has been busy developing policy related to biosimilars. The agency received 17 biosimilar initial advisory meeting requests between 2013 and 2015, and up to 51 FDA staff members are involved in each 351(k) biologic licensing application. The speakers suggested the agency may be going slowly in its review and approval of biosimilars, so as not to "poison the well" and prompt undue concerns about the safety. In addition, they said that because there is not yet FDA guidance on interchangeability, pharmacists should be alert for information on how substitutions can be made. Stevenson pointed out, meanwhile, that biologic and specialty pharmaceuticals make up the fastest-growing pharmaceutical expense in the United States, with The Economist predicting that biologics could account for a third of total pharmaceutical sales by 2023. He also discussed issues involved with naming biosimilars. One side believes that biosimilars should have the same international nonproprietary name (INN) as the reference products, while the other believes they should have a separate INN to distinguish them from the reference products and other biosimilars. FDA has suggested using an INN with a random four-letter suffix, including the reference products; however, there are concerns that such a complicated name could increase the risk of errors and lead to confusion.

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