Novartis biosimilar set to be first approved in US

A US FDA committee has voted unanimously in favour of Novartis’ biosimilar of Amgen’s Neupogen, paving the way for its approval as the first copycat biologic drug in the US.

The 14-strong Oncologic Drugs Advisory Committee recommended Novartis’ version of the drug filgrastim, named Zarxio, which promotes white blood cell production, in all five indications currently approved for the Amgen original.

The committee operates independently and the FDA is not obliged to follow its advisers’ recommendations, although it generally does. A final decision is expected in March.

Novartis’ drug has been marketed in Europe since 2009 under the brand name Zarzio, so that safety and efficacy data was available to the US committee.

Last year, Neupogen reportedly achieved sales of around $1.2 billion for Amgen. Biologic drugs are more complex than chemical formulations and often more expensive and Novartis will be hoping for a share of this market.

With tightening healthcare budgets, new biosimilar versions of biologics look set to be popular substitutions and could save the US $44 billion in the next 10 years, according to analysts.

The FDA gained the power to approve biosimilars in the 2010 Patient Protection and Affordable Care Act, commonly known as Obamacare.

Other biosimilars in the pipeline for FDA consideration include Celltrion’s application for a drug mimicking Johnson & Johnson’s arthritis treatment Remicade, which was filed in August 2014, and Apotex’s version of Amgen’s Neulasta in oncology, which was submitted in December.


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