How New Biosimilars Will Impact the Market

Editor’s note: An earlier version of this article incorrectly stated the brand name and maker for bevacizumab and the date for the marketing of infliximab. The article has been updated.

Following the success of some of the new biosimilar drugs, several more biosimilar drugs are expected to be launched in the United States in 2017 and 2018.

FDA approved four biosimilar drugs in 2015 and 2016, including Zarxio from Novartis, the biosimilar to filgrastim (Neupogen), which helps prevent infection during chemotherapy. After its first four months on the market, Zarxio had gained a 24% share of the market.

Because of competition from biosimilars, including Inflectra-the biosimilar to Remicade, which is used for rheumatoid arthritis and other inflammatory autoimmune conditions-some brand name drug sales appear to be suffering.

Johnson & Johnson's sales of Remicade (through its Janssen subsidiary) dropped 1.7% in the fourth quarter of 2016, according to Investopedia.

Amgen recently reported a sales decline in its Neupogen because of the competition from Sandoz’s Zarxio. Global unit sales of Neupogen dropped 25% for the fourth quarter of 2016, compared to the fourth quarter of 2015, and net sales declined 34%, according to Amgen.

Meanwhile, new biosimilars promise new competition. For example, Novartis has four biosimilars in the pipeline, and all will compete with very profitable medicines. By 2020, it will have launched biosimilars of adalimumab (Humira) for arthritis and other inflammatory conditions, pegfilgrastim (Neulasta) to prevent infection during chemotherapy, infliximab (Remicade), and the anticancer drug rituximab (Rituxan), according to Investopedia.

Also, Amgen and Allergan PLC have partnered to file an applicaton for a biosimilar to bevacizumab (Avastin), an anti-angiogenic drug from Genentech. The two companies are also partnering to develop three oncology biosimilar treatments, according to Investopedia.

In addition, Amgen said that its pegfilgrastim will face biosimilar competition in the United States by the end of the year. The FDA accepted applications for Neulasta biosimilars from Sandoz, Apotex, and Coherus, but has not yet approved any of those applications.

However, there are barriers to the future growth of biosimilars, including lawsuits and pricing. Janssen Biotech, Remicade’s manufacturer, sued Celltrion and Hospira (Inflectra manufacturers), saying that its Remicade patent doesn't expire until September, 2018. Pfizer has the rights to market Celltrion'sInflectra and the product has been on the market since November.

And, although biosimilars’ prices are an estimated 15% to 30% lower than their brand-name counterparts, they are still not as cost effective as a generic drug would be, since a generic can be 80% lower than its brand name counterparts.

Because of their prices and the lack of evidence about biosimilars’ effectiveness and interchangeability with their biologic counterparts, many physicians may be hesitant to prescribe the biosimilars. “At least for the first year or two after market launch of the biosimilar, it is less likely that a patient using a reference product on a chronic basis and stabilized on that product will be switched to the biosimilar, even if there is a cost advantage to doing so. The prescriber and patient will be reluctant to chance destabilizing the clinical situation,” Elan Rubenstein, PharmD, principal of EB Rubinstein Associates, a managed care and pharmaceuticals consultancy, told Drug Topics last summer.

In addition, with the pace of FDA’s biosimilar approvals, it will take a while for the savings of biosimilars to be realized in the United States. “At this time, there is not biosimilar competition. You won’t be seeing price pressure until more drugs get on the market,” Robert Adamson, PharmD, chief pharmacy officer, Corporate Pharmacy, for Barnabas Health in West Orange, NJ, which operates several hospitals and clinics, told Drug Topics last year.