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Herceptin, Rituxan Biosimilars Might Soon Reach Oncologists in Europe


European oncologists are expected to soon have access to biosimilars of 2 important anticancer antibodies—the blood cancer treatment rituximab (Rituxan) and breast cancer drug trastuzumab (Herceptin)—and the arrival of these biosimilars are expected to slash costs and expand patient access to these expensive oncology treatments. Biosimilars of these 2 drugs have previously seen a lot of delays.

While approval of biosimilar rituximab from the European Medicines Agency (EMA) is pending, preparations are being made for the launch of Celltrion’s rituximab biosimilar. The EMA’s website shows the agency is assessing 2 rituximab biosimilars and 3 trastuzumab biosimilars. The Mylan/Biocon trastuzumab biosimilar may be first of the 3 to be approved later this year in Europe. (There are biosimilars of both trastuzumab and rituximab in Asia, but Europe would be the first large market for these biosimilars; any launches in the United States are farther in the future.)

Although there are concerns about how quickly physicians and patients will adopt the new trastuzumab and rituximab biosimilars, worries about the ability of European healthcare systems to pay for current and future biologic reference drugs are leading cancer experts and healthcare providers to say they plan to support and use the biosimilars because they will save money and increase patient access. In Britain, the National Health Service (NHS) spends more than £300 million ($375 million) on rituximab and trastuzumab, and recently set a target for 90% of new patients treated in NHS hospitals to get biosimilars in the future. Pharmacists in the country are on board, too. The British Oncology Pharmacy Association recently said it was committed to optimizing the use of biosimilars in cancer treatment.

Some experts believe the adoption of trastuzumab and rituximab biosimilars in Europe will follow the model of how doctors there adopted biosimilar anti-tumor necrosis factor (TNF)-alpha drugs, used for rheumatoid arthritis (RA) and other immune disorders. It took a few months for physicians to become comfortable with the first biosimilars, but then demand for them took off. More importantly, competition has substantially driven down prices. Biosimilar anti-TNF-alpha agents now sell at approximately a 50% discount in Europe, and Novartis (it’s Sandoz division develops biosimilars) believes discounts could increase to as much as 75% in some cases. If the pattern for biosimilar RA drugs in Europe holds true, biosimilars for trastuzumab and rituximab are likely to start out at about 30% of the reference product price.

Newly diagnosed cancer patients are expected to be the first to receive the biosimilar anticancer agents. According to biosimilar drug maker Napp Pharmaceuticals, which will sell the Celltrion rituximab biosimilar in Britain, uptake of the drug will not be instant in every area but is expected to be much faster than has been seen in the past with biosimilars.

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