Sandoz: Zarxio marketing to be similar to a branded-drug launch

Novartis's marketing for Zarxio, its biosimilar copy of Amgen's cancer biologic Neupogen, will look more like a branded-drug launch than a generic one, a strategy that likely will be mimicked by other manufacturers of biosimilars.

The Swiss manufacturer said Thursday that it had launched Zarxio (filgrastim-sndz) in the US after a federal judge ruled against Amgen, which had been seeking a temporary injunction blocking the launch. The FDA approved Zarxio in March.

“The approach for marketing biosimilars is much closer to the approach for a branded product than that of generic medicine, and as such Sandoz has a fully integrated commercial organization behind the launch of Zarxio,” Leslie Pott, vice president of communications for Sandoz, the Novartis subsidiary responsible for marketing Zarxio, said in an email.

Zarxio is the first biosimilar approved by the FDA. How the drug is marketed by Novartis and received by patients and physicians may indicate how well other biosimilars will perform in the US market once they are approved.

Unlike generic drugs, which are like direct copies of branded drugs, biosimilars are considered “highly similar” but not identical to the already-approved biologic, which is referred to as a reference product. New versions of biologic drugs can be approved as interchangeable, meaning they can be substituted by a pharmacist without the oversight of the prescriber, or they can be approved as a biosimilar, which means they may function more as therapeutic alternative rather than an equivalent.

“We have spoken to many customer and stakeholder groups about biosimilars and we have seen interest over the last few months prior to launch,” Pott said.

Sandoz is taking a branded-drug approach because Zarxio's class is a new market for the company, and it has successfully marketed biosimilars outside of US using a similar approach, she added. The company also commercialized Omnitrope, a human growth hormone product that is considered “biosimilar-like,” starting in 2006.

A study published in June 2014 in Health Affairs predicted that competition between biosimilars and reference products will look more like competition between branded drugs rather than competition between a branded drug and generic drug.

Sandoz has established a commercial organization for Zarxio that includes sales, marketing and medical professionals who are oncology experts. It is also offering a patient support services center for patients seeking information about reimbursement and co-pay support.

There are no plans to conduct a direct-to-consumer advertising campaign, according to Pott, who declined to provide additional information about Zarxio's marketing plans, citing competitive concerns.

Bernstein analyst Ronny Gal had said in January that Sandoz would employ a sales and marketing team of about 50 people.

The FDA approved Zarxio for the same five indications as Neupogen, which first came to market in 1991 and generated nearly $1.6 billion in sales in 2014, with about $839 million of that coming from the US market.

The drugs treat several conditions, including patients with cancer who are undergoing myelosuppressive chemotherapy and patients with cancer who have had a bone marrow transplantation. (Teva's Granix, which launched in late 2013, is considered a competitor to Neupogen, but it is a biologic, not a biosimilar, and it is approved to treat one indication.)

Experts have said that the imminent biosimilar market will likely help drive down drug costs, in part by creating competition and also because biosimilars are expected to come to market with lower prices than their biologic counterparts. Zarxio is priced at a 15% discount compared to Neupogen, costing between $275 and $438 per injection based on the dose, according to media reports.

As the market for biologics, many of which are first-in-class products, grows, the demand for lower prices and therapeutic options has increased.

Seven of the 21 top-selling drugs in 2011 were biologics and 40% of clinical trials are testing biologic products, according to the 2014 study in Health Affairs. These include Johnson & Johnson's Remicade and Avastin, the standard of care for many oncology patients.

But there are several reasons why biosimilar adoption among healthcare providers may be slow. Many physicians may choose to only prescribe biosimilars to new patients rather than patients already taking a biologic, a similar practice compared to when doctors are reluctant to switch a patient satisfied with one brand-name drug to another brand-name drug, according to the study.

Marketing and detailing—industry jargon for promotional interactions between pharma sales forces and physicians—“can help establish the reputation of biosimilars with hospital pharmacy and therapeutics committees and physicians as viable therapeutic options,” the authors wrote.

Pharmacy and therapeutics committees at hospitals and health systems usually maintain formularies for therapies prescribed in clinical settings, such as cancer drugs. Zarxio is administered in a clinical setting.