Sandoz files biosimilar application

Sandoz has had its Biologics Licence Application for filgrastim accepted by the US FDA.

The application was filed under the new biosimilar pathway created in the Biologics Price Competition and Innovation Act of 2009 (BPCIA).

The reference product – Amgen’s Neupogen – is indicated to decrease the incidence of infection, as manifested by febrile neutropenia, in patients with nonmyeloid malignancies receiving myelosuppressive anticancer drugs associated with a significant incidence of severe neutropenia with fever.

The biosimilars market is highly lucrative, with more than 100 deals completed in the past seven years, valued at well in excess of $10 billion. Analysts at GlobalData state that biosimilars will have a noticeable negative impact on the biologics market beyond 2019, capturing the market share from biologics as a result of patent expirations and the introduction of clearer regulatory frameworks for biosimilars.

“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 Dr Mark McCamish, head of global biopharmaceutical and oncology injectables development at Sandoz. “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.”

Under the brand name Zarzio, the Sandoz biosimilar filgrastim has been marketed in more than 40 countries outside the US, generating nearly six million patient-exposure days of experience. ZARZIO is the number one biosimilar filgrastim globally and is the leading daily G-CSF in Europe with 30 per cent volume market share.

Sandoz, part of the Novartis Group, is a pioneer in biosimilars and the global market leader. It has six molecules in phase III clinical trials/filing preparation. It had sales of $9.2 billion in 2013.

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