FDA Approves First Biosimilar Product Zarxio

(RTTNews) - US Food and Drug Administration or FDA, announced Friday the approval for Swiss drug maker Novartis AG's (NVS) white blood cell growth hormone Zarxio TM (filgrastim-sndz) as first biosimilar product approved in the U.S. Zarxio is biosimilar to Amgen Inc.'s (AMGN) Neupogen (filgrastim), which was originally licensed in 1991.

"Biosimilars will provide access to important therapies for patients who need them. Patients and the health care community can be confident that biosimilar products approved by the FDA meet the agency's rigorous safety, efficacy and quality standards," said FDA Commissioner Margaret Hamburg.

Biological products are generally derived from a living organism such as humans, animals, microorganisms or yeast.

A biosimilar product is a biological product that is approved based on a showing that it is highly similar to an already-approved biological product, known as a reference product, for all indications included in the reference product's label.

A biosimilar product can also only be approved by the FDA if it has the same mechanism of action, route) of administration, dosage form and strength as the reference product.

Zarxio is approved for the same indications as Neupogen. These include indications for patients with cancer receiving myelosuppressive chemotherapy, and patients with cancer undergoing bone marrow transplantation.

It is also indicated for patients undergoing autologous peripheral blood progenitor cell collection and therapy as well as patients with severe chronic neutropenia.

The approval was based on a comprehensive package of analytical, nonclinical, and clinical data, which confirmed that Zarxio is highly similar to the US-licensed reference product.

The approval comes after Zarxio received the unanimous positive vote in January by the Oncologic Drugs Advisory Committee (ODAC) based on data from Sandoz's pivotal head-to-head PIONEER study.

For this approval, the FDA has designated a placeholder nonproprietary name for this product as "filgrastim-sndz."

Zarxio is a product of Princeton, New Jersey-based Sandoz, the generic pharmaceuticals division of Novartis. Sandoz is the world's second largest generic drug maker, trailing only Israel-based Teva pharmaceutical Industries Ltd. (TEVA).

Sandoz is the first company to receive approval of a biosimilar in the U.S. through the new FDA biosimilars pathway established under the Biologics Price Competition and Innovation Act of 2009 (BPCIA), which was signed into law in March 2010 by President Obama. The act paved the way for less expensive alternatives to an entire class of complex and costly drugs.

"As the global leader in biosimilars, we are honored to be the first company to successfully work with FDA to navigate the US biosimilar pathway and we look forward to making this high-quality biosimilar available to patients in the US," said Carol Lynch, Global Head of Biopharmaceuticals & Oncology Injectables at Sandoz.

NVS closed Friday's regular trading session at $97.46, down $1.49 or 1.51% on a volume of 1.22 million shares.