Sandoz Biosimilar to Amgen's Neulasta Filed for Regulatory Approval

After a lot of skirmish, Sandoz was finally able to launch the first-ever biosimilar product in the United States in September 2015—a good 6 months after being granted FDA approval. Now, the company, which is the generics wing of Novartis, has announced the filing of its Biologics License Application (BLA) for its proposed biosimilar to Amgen’s Neulasta (pegfilgrastim).

Neulasta, a pegylated form of recombinant human granulocyte colony-stimulating factor, is indicated to reduce the incidence of infection in patients with non-myeloid malignancies who are receiving myelosuppressive anticancer agents. Neulasta was approved in 2002. Sandoz is seeking approval for the same indication as its reference product. The BLA includes results from 2 pivotal clinical trials: a drug distribution trial in health volunteers and 2 comparative efficacy trials and safety studies in breast cancer patients.

Sandoz is a leader in generic products and has a growing biosimilar pipeline, which includes products for blockbuster molecules adalimumab (Humira) and rituximab (Rituxan). The company recently filed a BLA for a biosimilar to etanercept, a TNF-alpha inhibitor marketed as Enbrel by Amgen.

“The FDA’s acceptance of our regulatory submission for biosimilar pegfilgrastim—our third biosimilar filed in the US—demonstrates our commitment to expanding patient access to biologics in the US,” said Mark McCamish, MD, PhD, who heads Global Biopharmaceutical & Oncology Injectables Development at Sandoz.

The discussion of course could boil down to cost, once approved. Will the biosimilar cost significantly lower than its reference product, which according to patient blog posts and the website GoodRx could be priced at anywhere between $3000 and $7000 for a single injection? Neulesta is recommended to be administered once per chemotherapy cycle in adults. What would make providers switch therapy and payers consider coverage for a biosimilar that may not have a significant cost advantage?

Zarxio, the biosimilar to Neupogen, is being sold at 15% lower price compared with the reference product.