Novartis AG's Sandoz Bags Approval for First Biosimilar to be Sold in the U.S.
March 6, 2015
By Riley McDermid, BioSpace.com Breaking News Sr. Editor
Swiss drugmaker Novartis AG won approval from the U.S. Food and Drug Administration (FDA)for the nation’s first biosimilar drug Friday, after the FDA said the company could now sell its white blood cell drug Zarxio, a knockoff of Amgen ’s blockbuster treatment Neupogen, or filgrastim.
“Biosimilars will provide access to important therapies for patients who need them,” said FDA Commissioner Margaret Hamburg. “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.”
Biosimilars, which are made inside a living cell, are always uniquely different in composition, which differentiates them from generic drugs, which are exact replicas of other drugs. They have been widely available in Europe since 2006, but the FDA was only granted the right to review and approve them when Obamacare was passed in 2010.
"The FDA approval of Zarxio marks a significant milestone for the United States healthcare system and for patients who might suffer from neutropenia," said Carol Lynch, global head of biopharmaceuticals and oncology injectables at Sandoz, in a statement. "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."
Neupogen raked in $1.2 billion for Amgen last year, a lucrative market that Novartis, and its Sandoz unit that makes Zarxio, are now eyeing eagerly. The FDA said in January that an internal panel seemed inclined to give Zarxio the green light to treat the same five conditions Neupogen does. Sandoz declined to issue a price target for Zarxio
The company also still faces legal challenges from Amgen, and Sandoz has a district court hearing on the matter March 13. In the meantime, it has agreed to delay its U.S. launch until a ruling is made on a preliminary injunction, or until April 10, whichever comes first.
The FDA granted approval after parsing a Sandoz pivotal head-to-head PIONEER study that showed high similarity between the two drugs. During that study, Zarxio and the reference product both produced the expected reduction in the duration of severe neutropenia in cancer patients undergoing myelosuppressive chemotherapy (1.17 and 1.20 days for Zarxio and the reference product, respectively). The mean time to absolute neutrophil count recovery in cycle 1 was also similar (1.8 days ± 0.97 in ZARXIO arm vs 1.7 days ± 0.81 in reference product arm). No immunogenicity or antibodies against rhG-CSF were detected throughout the study.
That data was enough for the FDA to issue the historic decision, opening the floodgates for the biosimilar market to begin flooding American markets, a move that has long been sought by U.S. health insurers and other large health cost payers. With cheaper biosimilar drugs, health costs will come down for patients everywhere, they’ve argued, particularly as expensive patented drugs lose their protection.
Marketed as Zarzio outside of the US, the Sandoz biosimilar filgrastim is available in more than 60 countries worldwide.
Neutropenia, the condition both drugs treat, happens when common white blood cells, neutrophils, dip below healthy levels, most commonly due to cancer treatment or advanced HIV/AIDS.
"Filgrastim has proven clinical value in treating patients at increased risk of neutropenia, but it is underused in the US for a variety of reasons, including price" said Louis Weiner, chairman of the department of oncology and director of the Lombardi Comprehensive Cancer Center at Georgetown University. "Biosimilars have the potential to increase access and the approval of Zarxio may reduce costs to the healthcare system. The comprehensive data set supports its use in clinical practice."
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