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Sandoz begins two phase III trials of Amgen biosimilars

Novartis generics division to trial biosimilar versions of Neupogen and Neulasta

Novartis’ generics business Sandoz has moved its biosimilar versions of two Amgen products into phase III trials.

The two studies will evaluate the efficacy and safety of biosimilars of Neupogen (filgrastim) and Neulasta (pegfilgrastim), both of which are used to treat side effects of chemotherapy.

Biosimilar filgrastim, marketed as Zarzio in more than 30 countries, is being studied in breast cancer patients eligible for myelosuppressive chemotherapy treatment to back its US marketing application.

Sandoz’s biosimilar pegfilgrastim is also being studied in breast cancer patients eligible for myelosuppressive chemotherapy, and the trial’s results will be used support that drug’s global commercialisation prospects.

Sandoz already has two biosimilar products available outside the US – growth hormone Omnitrope (somatropin) and the anaemia treatment Binocrit (epoetin alfa).

Omnitrope is also available in the US, but was approved by the Food and Drug Administration (FDA) as a follow-on protein product, rather than a biosimilar, allowing the regulator to rely on clinical data regarding the safety and effectiveness of the approved protein product Genotropin.

Division head of Sandoz Jeff George described the company as the “clear global leader” in biosimilars, citing the success of their three current products and further eight to 10 molecules in development.

He added: "These two development milestones demonstrate that we also continue our efforts to make good on the longer-term promise of our leading pipeline."

Further biosimilar products under investigation by Sandoz include a version of Roche's Rituxan for non-hodgkins lymphoma.

Biosimilar regulation

Sandoz’s new biosimilar trials follow the FDA's recent move to introduce a biosimilar user-fee programme.

This gives more details to the Biologics Price Competition and Innovation Act (BPCI), would allocate resources to the FDA to help biosimilar developers bring products to market and should also help build a biosimilar approval pathway in the US.

Meanwhile, European biosimilar regulations are also due to be updated. In December 2011 the European Medicines Agency (EMA) announced plans to update its 2005 guidelines to clarify the definition of biosimilars as well as their legal basis. The new guidelines are due to be published in March or April this year.

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