Biosimilar: Coming to a pharmacy near you
After brisk sales through specialty pharmacy, biosimilars are moving toward community pharmacy. Basaglar (insulin glargine injection; Lilly, Boehringer Ingelheim), the first FDA-approved follow-on recombinant insulin, could hit pharmacy shelves in December.
Manufacturers have been prepping for years. About half of the states have enacted statutory or regulatory frameworks for biosimilar substitution. Nearly all were written and sponsored by industry, with little or no input from pharmacy.
Pharmacy benefit managers and payers have been positioning biologics, such as Lantus (insulin glargine injection, Sanofi-Aventis), Neupogen (filgrastim, Amgen), and Remicade (infliximab, Johnson & Johnson), to take advantage of biosimilar competition from Basaglar, Zarxio (filgrastim-sndz, Novartis), and Inflectra (infliximab-dyyb, Celltrion). Industry observers count another 50-plus biosimilars in the FDA approval process.
“Biosimilars are the future of pharmacy,” said Jillanne Schulte, director of federal regulatory affairs for the American Society of Health-System Pharmacists. “We are seeing the forefront of the coming wave of innovation in health care. When biosimilars hit community pharmacy, issues like interchangeability that have been important in specialty settings are going to explode. Biosimilars are the frontier of medicine.”
Biosimilar, not generic
Biosimilars have been a staple in European healthcare for a decade. The European Medicines Agency (EMA) created its biosimilars pathway in 2005 and has approved at least 19 biosimilars in six product categories: epoetins, filgrastims, follitropins, growth hormones, insulins, and monoclonal antibodies.
EMA-approved biosimilars are priced about 30% below the reference product, according to Express Scripts. The PBM projects US savings of nearly $22.7 billion by 2024 from the approval of Zarxio and Inflectra and $250 billion from a basket of 11 biosimilars currently awaiting FDA approval.