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BPC Statement on FDA Approval of Etanercept Biosimilar

August 31, 2016

The Biologics Prescribers Collaborative (BPC) welcomes the U.S. Food and Drug Administration (FDA)'s decision yesterday to approve the third biosimilar in the United States, Sandoz biosimilar to Amgen’s Enbrel (etanercept). This approval represents an important step towards realizing the promise of biosimilars to expand patient access to these lifesaving therapies.

BPC appreciates FDA's continuing careful deliberation on biosimilar-related issues, however the decision approve a third biosimilar without FDA finalizing their decisions on naming, labeling or interchangeability policies for biologics does cause concern and creates confusion.

Patient safety must be prioritized to ensure prescriber confidence in, and the safe use of, biosimilars. BPC believes that pharmacovigilence is best achieved through the use of memorable and distinguishable non-proprietary names for all biologics. For this approval, FDA has provided a nonproprietary name for the product as "etanercept-szzs”  In October of 2015, FDA released the "Nonproprietary Naming for Biologic Products" draft guidance, calling for each biological product to be a assigned a distinguishable name through the use of a four letter randomized suffix. However, a randomized four-letter code may complicate the achievement of FDA's goal to improve pharmacovigilance and prevent inadvertent substitution. A memorable suffix, such as one that reflects the manufacturer, is immediately recognizable and will facilitate prompt, accurate adverse event reporting by patients and physicians to the correct manufacturer, and that manufacturer's mandated reporting to FDA. As such, the BPC strongly encourages FDA to issue a final naming guidance and adopt a naming suffix format that is memorable and reflective of the manufacturer name - as originally illustrated by the first biosimilar approval of filgrastim-sndz.

The product label is a critical tool for physicians to make the best prescribing decisions. We request the Agency finalize its current draft guidance to support fully transparent and clear labels for biosimilars. We appreciate the biosimilarity statement included, however this newly approved biosimilar was issued labeling and prescribing information that is lacking important information. Notably, this label fails to include a statement of whether the biosimilar is interchangeable with the reference product and/or other biosimilars on the market. Additionally, the label does not include a summary of the full clinical data submitted in support of biosimilar approval or a hyperlink to the FDA’s summary basis of approval.

BPC applauds FDA for taking the actions needed to approve biosimilar medicines and urges FDA to adopt naming and labeling policies that reflect the patient safety concerns identifies by prescriber and patient organizations.