FDA Panel Recommends Approval of Sandoz’s Biosimilar Version of Neupogen

A panel of advisors for the US Food and Drug Administration (FDA) has recommended approval of Novartis’ investigational biosimilar version of Amgen’s Neupogen (filgrastim).

The agency’s independent Oncologic Drugs Advisory Committee (ODAC) voted 14-0 in favor of approving Novartis’ biosimilar version of Amgen’s cancer drug Neupogen, which boosts white blood cell production. Although the FDA is not required to follow the recommendation made by the group, it often does.

The committee’s decision has paved the way for the introduction of the first ever biosimilar in the US market. It came two days after an FDA staff review determined that Novartis’ biosimilar should be approved for all the five indications Neupogen is currently approved for. The FDA is expected to make a final decision on its approval in the coming months.

Novartis’ generic arm Sandoz plans to launch the drug under the name Zarzio, which is currently marketed under the brand name Zarzio in more than 40 countries outside the US, generating nearly 7.5 million patient-exposure days of experience.

“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 & Oncology Injectables Development at Sandoz. “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.”

Amgen’s Neupogen generated an estimated $1.2 billion in sales in 2014. It is a part of the growing class of biologic medicines that are more complex and generally more expensive than chemical drugs. Biosimilars are not expected to reduce drug prices to the extent that chemical generics do. Novartis may charge the same price for Zarxio as Neupogen in some indications, but the cost to insurers and consumers will be lower.

Source: Sandoz


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