Generics and Biosimilars Initiative (GaBI) (01/22/2016)

In the biosimilars arena, the most important milestone achieved last year was the U.S. Food and Drug Administration's (FDA) decision on March 6 to approve Sandoz's filgrastim biosimilar, Zarxio, for all five indications of the originator product (Neupogen). The agency is reviewing applications for epoetin alfa, infliximab, etanercept, filgrastim, and pegfilgrastim biosimilars as well. The European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use recommended approval of Benepali (SB4) in November 2015, and it is currently reviewing biosimilar applications for enoxaparin sodium, etanercept, infliximab, pegfilgrastim and rituximab. In the area of naming biosimilars, the World Health Organization said nearly half of the comments it received praised its proposed biological qualifier (BQ) approach, while the Generic Pharmaceutical Association backed the International Nonproprietary Name (INN) approach. The FDA has proposed that all biologicals and biosimilars have non-proprietary names and that a four-letter suffix be added to the names to distinguish them from each other. In January 2015, consensus was achieved on a compromise requiring dispensing pharmacists to "communicate to the prescriber the specific product provided to the patient, including the name of the product and the manufacturer" "within a reasonable time." Thirteen states--including California, Massachusetts, and Texas--have passed or are considering legislation allowing substitution of a biosimilar for an originator biological. The FDA issued four final biosimilars guidance documents in 2015, and the EMA released its finalized guideline on the non-clinical and clinical development of insulin biosimilars in March 2015.

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