FDA Committee Recommends First Biosimilar Approval

Pharmaceutical manufacturing in the United States inched a step closer to a historic milestone today when the FDA Oncologic Drugs Advisory Committee (ODAC) recommended approval of the investigational biosimilar, filgrastim (Zarzio).

On July 24, 2014, Sandoz, a Novartis Group company, became the first company to file for approval of a biosimilar in the United States through the pathway created by the Biologics Price Competition and Innovation Act of 2009. Filgrastim is a biosimilar of the reference product Neupogen by Amgen, which is indicated to decrease the incidence of infection in patients with non-myeloid malignancies who also are receiving myelosuppressive anti-cancer drugs.

"We are pleased with the ODAC's recommendation to approve our biosimilar filgrastim and we look forward to continuing to work with FDA as it completes its review of our filing," said Mark McCamish, MD, PhD, head of Global Biopharmaceutical and Oncology Injectables Development at Sandoz, in a press release. "We are proud to lead the way in biosimilars globally and believe this positive recommendation brings us one step closer to delivering high-quality biosimilars to patients in the US."

ODAC also recommended the approval of filgrastim for use in all indications included on Neupogen’s label.

The recommendation followed the presentation of a comprehensive package of nonclinical, clinical, and post-marketing pharmacovigilance data that showed filgrastim is highly similar to Neupogen. The package included a pharmacokinetic and pharmacodynamics study that established bioequivalence, and a clinical efficacy and safety study in which the drug exhibited the same clinical performance and safety as Neupogen in the treatment of breast cancer patients.

Filgrastim has already been sold in more than 40 countries outside the United States, with nearly 6 million patient-exposure days of experience, according to Novartis. Sandoz maintains more than 50% share of all biosimilars approved in Canada, Europe, Japan, and Australia, with 3 biosimilars presently marketed outside the United States.

Sandoz biosimilars have been sold in more than 60 countries with more than 200 million patient-exposure days of experience, according to the press release. A recent report by Moody’s Investors Service estimated that biosimilars were at least 3 years away from hitting the US market.

While estimates for the potential savings from biosimilars vary, a paper published in February 2014 on the Social Science Research Network indicates that over the next 10 years, American consumers could save more than $250 billion from biosimilar competition for just 11 biologic drugs if they were approved by the FDA.

In an interview with Specialty Pharmacy Times, Javier Coindreau, MD, vice president of global medical affairs for the Pfizer Biosimilars Business Unit, was less optimistic, as he believes the innovator compounds will try to protect their market share as much as possible. He did, however, emphasize the importance of biosimilars to mitigate skyrocketing drug prices.

“One of the things biosimilars provide is competition, and with that the potential for increased access,” Dr. Coindreau said. “One of the most important reasons biosimilars should be available is the need for these drugs are huge and in most cases, in these therapeutic areas, access is not easy. So by increasing competition, biosimilars increase access for patients requiring these drugs but who currently don’t have access.”