FDA Accepts First Application in US for Biosimilar

Biologics License Application filed for filgrastim by Sandoz.

A landmark in American pharmaceutical manufacturing was reached on July 24, 2014, as 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.

The company filed for the approval of filgrastim (ZARZIO), 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.

"This filing acceptance represents a significant step toward making high-quality biologics more accessible in the US and we applaud FDA for its progress in making this a reality," said Mark McCamish, MD, PhD, head of Sandoz Global Biopharmaceutical and Oncology Injectables Development in a press release.

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. ZARZIO is the number one filgrastim biosimilar in the world and is the leading daily G-CSF in Europe with 30% volume market share, Novartis said.

Sandoz maintains over 50% share of all biosimilars approved in Canada, Europe, Japan, and Australia, with 3 biosimilars presently marketed outside the US. Sandoz biosimilars have been sold in more than 60 countries with over 200 million patient-exposure days of experience, according to the press release.

A recent report by Moody’s Investors Service estimated 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.”

Avalere Health released a statement projecting the approval of ZARZIO to come as soon as the first quarter of 2015. It still remains unclear how patients, health care providers, and physicians will react to biosimilars hitting the US market. A recent survey found that more than 90% of senior citizens did not even know what biosimilars are.

Dr. Coindreau noted that manufacturers must step up education efforts to inform the medical community and the general public as to the general concept of biosimilarity.

“We speak with physicians all the time,” he said. “We speak with patient associations, with medical associations, advocacy groups, and we really see the need for education around biosimilars and biosimilarity. We need to find a way to communicate the importance of biosimilars and the high potential they have, especially the quality behind the molecules and how the entire concept of biosimilarity is based on the molecular structure of the candidate drug. It is a big challenge.”

Avalere projected that the first biosimilars to be approved in the United States will most likely be those previously approved in Europe, however the adoption of biosimilars will follow different patterns due to the US health care system.

"As they've done in Europe and other highly-regulated markets around the world, biosimilars are poised to increase US patient access to affordable, high-quality biologics, while reducing the financial burden on payers and the overall healthcare system,” Dr. McCamish said.