What the new biosimilar means for U.S. healthcare

Generic drug manufacturers–along with physicians and pharmacists– welcomed FDA’s recent approval of etanercept-szzs (Erelzi), a biosimilar to Amgen’s top-selling Enbrel for rheumatoid arthritis, plaque psoriasis, and other inflammatory conditions.

Enbrel netted sales of $5.1 million in the United States last year, and the new biosimilar stands to save the healthcare system millions of dollars annually. Savings to the U.S. healthcare system from all biosimilars are projected to reach between $57 and $110 billion from 2015 through 2020, according to the IMS Institute for Healthcare Informatics

“Gaining product approval is just one part of system-wide efforts to realize the promise of biosimilars. Regulators, policymakers, and others must ensure that today’s decisions on reimbursement, interchangeability, and other issues foster tomorrow’s development of a robust biosimilars marketplace,” said Christine Simmon, executive director of the Biosimilars Council and senior vice president of policy and strategic alliances for the Generic Pharmaceutical Association (GPhA). “These considerations will be critical, so that biosimilars, safe, effective, and more affordable alternatives to costly brand biologics, can deliver cost savings for patients and America’s healthcare system.”

This is the third biosimilar approval by the FDA. The agency first approved filgrastim-sndz (Zarxio), the biosimilar to Amgen’s Neupogen for patients with certain cancers undergoing chemotherapy, in March, 2015. Then, this April, FDA approved infliximab-dyyb (Inflectra), a biosimilar to Janssen Biotech, Inc.’s Remicade (infliximab), also for RA and other inflammatory conditions.

 “The biosimilar pathway is an important mechanism to improve access to treatment for patients with rheumatic and autoimmune diseases,” said Janet Woodcock, MD, director of the FDA’s Center for Drug Evaluation and Research. “We carefully evaluate the structural and functional characteristics of these complex molecules. Patients and providers can have confidence that there are no clinically meaningful differences in safety and efficacy from the reference product.”

FDA’s approval follows a unanimous vote by FDA's Arthritis Advisory Committee (AAC) in July to recommend use in all indications of the reference product. The approval is based on a comprehensive package of analytical, nonclinical, and clinical data confirming that Erelzi is highly similar to the reference product.

Clinical studies included four comparative pharmacokinetic (PK) studies in 216 healthy volunteers and a confirmatory efficacy and safety similarity study in 531 patients with chronic plaque psoriasis. “Extrapolation to all indications approved for use on the reference product label is on the basis that the Sandoz biosimilar etanercept and the reference product are essentially the same,” Sandoz said.

In addition, application for Sandoz’s biosimilar etanercept is under review by the European Medicines Agency.

However, it is not clear when Erelzi will make it market in the U.S. This spring, Amgen sued Sandoz over Erelzi, claiming Sandoz was “piggybacking on the fruits” of its “trailblazing efforts” with Enbrel, according to FiercePharma. Amgen asked a U.S. District Court judge for an injunction to block sales of Sandoz’s biosimilar.

However, the overall market for biosimilars remains strong, with an active pipeline of 55 new products in clinical development, according to the IMS Institute. Plus, by 2020, eight major biologic medicines are expected to lose exclusivity protection, including treatments for auto-immune disorders and diabetes.

“By opening markets to biosimilar competition, healthcare systems could realize a 30 percent reduction in price per treatment day compared to originator biologics,” said IMS Institute in a statement.