Sandoz launches first US biosimilar

pharmafile | September 3, 2015 | News story | Manufacturing and Production, Sales and Marketing Amgen, Neupogen, Novartis, Sandoz, Zarxio, biosimilar, biosimilars, filgrastim 

Sandoz, the generics arm of the pharma giants Novartis, has become the first company to launch a biosimilar product in the US.

After a lengthy court battle with Amgen, the manufacturer of the original Neupogen (filgrastim), Sandoz has become the first company to launch a biosimilar in the US – which is further behind Europe in the adoption of biosimilar drugs.

These medicines are a type of biological product that are licensed and approved because they are highly similar to an already approved biological product, known as the reference product, and have been shown to have no clinically meaningful differences from the reference product.

Zarxio, Sandoz’s biosimilar version of Neupogen, was approved by the FDA’s oncologic drugs advisory committee (ODAC). The committee assessed a package of clinical data and concluded that ‘Zarxio is highly similar’ to the US-licensed Neupogen product. 

Amgen had gone to court to try and block Zarxio from the US market, and requested an injunction blocking the product from sale and encroaching on Neupogen’s $1.1 billion dollar market share. The biosimilar is already available more than 40 countries under the name Zarzio. The drug is prescribed to boost white blood cell count and decrease the chance of infection in people receiving chemotherapy for some cancers.

Richard Francis, global head at Sandoz, says: “As the pioneer and global leader in biosimilars, Sandoz has maintained a commitment to bringing high-quality biosimilar medicines to patients and healthcare professionals around the world. With the launch of Zarxio, we look forward to increasing patient, prescriber and payor access to filgrastim in the US by offering a high-quality, more affordable version of this important oncology medicine.”

And Dr Ralph Boccia, medical director of the center for cancer and blood disorders and chief medical officer for the International Oncology Network, says: “While biologics have had a significant impact on how diseases are treated, their cost and co-pays are difficult for many patients and the healthcare budget in general.”

“Biosimilars can help to fill an unmet need by providing expanded options, greater affordability and increased patient access to life-saving therapies,” he adds.

Lilian Anekwe

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