Novartis AG Hopes to File 10 Big Biosimilars in the Next Three Years


October 27, 2015
By Alex Keown, BioSpace.com Breaking News Staff

ZURICH – Following the approval of its landmark biosimilar drug in the United States, Novartis AG is looking for 10 more biosimilar filings within the next three years, Reuters reported in a brief this morning.

In August Joe Jimenez, Novartis’ chief executive officer, predicted the biosimilar market will hit a stride in three to five years. Currently biosimilar drugs earn Novartis about $500 million annually and Jimenez told Reuters then that he expected that amount to increase by about 20 percent annually. Jimenez predicted the biosimilar role will take off by 2020 at the latest as popular prescription medications lose patent protection. Swiss-based Roche may soon see biosimilar competition in Europe for its blood cancer drug MabThera (Rituxan in the United States), which lost patent protection in Europe in 2014.

Biosimilars, which are made inside a living cell, are always uniquely different in composition, which differentiates them from generic drugs, which are exact replicas of other drugs. They have been widely available in Europe since 2006, but the FDA was only granted the right to review and approve them when Obamacare was passed in 2010.

Citigroup analysts have predicted a transfer of at least $110 billion of value from innovator companies to copycat producers in the next decade, Reuters said. Express Scripts, a manager of drug benefit plans in the U.S., estimated the U.S. could save $250 billion over a 10 year span of 2014 and 2024 if 11 of the likeliest biosimilars reach the market, Reuters said.

In September, Novartis launched the first approved biosimilar in the United States after a U.S. court denied Amgen ’s appeals to block sales of the drug, which is a “copycat” version of that company’s blockbuster treatment Neupogen.

By offering Zarxio at a price point 15 percent below Neupogen, Novartis and its biosimilar subsidiary Sandoz are looking to take a big chunk of the $1.2 billion the drug raked in last year. A 300 microgram syringe of Zarxio is expected to cost $275.66 and the 480 mcg version is expected to have a wholesale cost of $438.98, Reuters said. Wholesale price points for Neupogen are $324.30 and $516.45 for the same syringe formulations.

In addition to Novartis, companies such as Israel’s Teva Pharmaceutical Industries Ltd. and South Korea’s Celltrion Biopharmaceuticals are developing biosimilars to treat cancer and other autoimmune diseases, Reuters said.

NovartisZarxio, which is manufactured by its subsidiary Sandoz, Inc., was approved under the biosimilars pathway established by the Biologics Price Competition and Innovation Act. Data has shown Zarxio had “no clinically meaningful differences to the US-licensed reference product,” the company said. During the head-to-head PIONEER study between Zarxio and Neupogen, both products produced the expected reduction in the duration of severe neutropenia in cancer patients undergoing myelosuppressive chemotherapy (1.17 and 1.20 days for Zarxio and the reference product, respectively). The mean time to absolute neutrophil count recovery in cycle one was also similar (1.8 days ± 0.97 in ZARXIO arm vs 1.7 days ± 0.81 in reference product arm). No immunogenicity or antibodies against rhG-CSF were detected throughout the study. Neutropenia, the condition both drugs treat, happens when common white blood cells, neutrophils, dip below healthy levels, most commonly due to cancer treatment or advanced HIV/AIDS.

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