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Sandoz earns historic first FDA biosimilar vote

Published on 08/01/15 at 11:01am
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Sandoz has taken a huge step forward in the race to be the first company to market a biosimilar in the US, after the FDA’s oncologic drugs advisory committee recommended its biosimilar version of Amgen’s Neupogen.

The committee recommended Zarxio (filgrastim) should be approved for use in all indications for which the original product is approved. The drug is prescribed to decrease the chance of infection in people receiving chemotherapy for some cancers.

Regulatory approval for biosimilars is based on a manufacturer showing that its biosimilar is highly similar and has the same quality as the original product, and that they are as safe and as effective as the original medicine.

Sandoz provided the FDA with non-clinical and clinical data in healthy volunteers and breast cancer patients, and post-marketing pharmacovigilance data gathered from more than 40 countries where the drug is already available (under the name Zarzio).

The FDA panel voted unanimously – 14 votes to 0 – in favour or recommended Zarxio, after concluding there were ‘no clinically meaningful differences’ between Zarxio and Neupogen.

Dr Mark McCamish, head of global biopharmaceutical and oncology injectables development at Sandoz, says: "We are pleased with the ODAC's recommendation to approve our biosimilar filgrastim and we look forward to continuing to work with FDA as it completes its review of our filing.

"We are proud to lead the way in biosimilars globally, and believe this positive recommendation brings us one step closer to delivering high-quality biosimilars to patients in the US."

Biosimilars can offer in the region of a 30% discount on the price of their original products, although they still require substantial R&D investment to replicate large and complex biological molecules.

Analysts have predicted that the global market for biosimilars will be substantial. A recent report from Allied Marketing Research estimates that worldwide sales for copycat biologicals will reach $35 billion by 2020, as blockbusters like AbbVie's Humira (adalimumab) and Janssen's Remicade (infliximab) come off patent.

The US is far behind the UK and the rest of the world in taking up biosimilars. NICE anticipates that “it is likely that their availability and use will become more widespread over the next few years.”

On the same day the FDA vote was announced, the healthcare watchdog updated its position on how it will review biosimilars for cost-effectiveness.

NICE will review biosimilars in parallel with their reference products in the indication under consideration. The Department of Health in England has also confirmed that NICE will be able to decide to apply the same guidance as original products to “relevant licensed biosimilar products which subsequently appear on the market”.

Lilian Anekwe

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