March 21, 2018 — LONDON — Cut-price copies of an expensive Roche biotech drug for blood cancer have taken 80% of the British market since launching last year, saving the healthcare system £80 million ($113 million) a year, experts said. The rapid adoption of two biosimilar forms of rituximab from Celltrion and Novartis has been accompanied by discounts of 50–60% as the National Health Service (NHS) has used tenders to bring down costs. This contrasts sharply with the United States, where regulators have lagged Europe in approving biosimilars and a complex system of rebates offered to insurers by original-brand drugmakers has created barriers to use. The U.S. logjam prompted FDA Commissioner Scott Gottlieb to complain of "rebating mischief" and a "rigged payment scheme" in a speech on March 7. Biological drugs such as Rituxan, a $7 billion-a-year seller, are complex molecules made inside living cells. Copies of some biotech medicines have been on sale in Europe for more than a decade, but patents on big-selling antibody treatments for cancer and other serious diseases are only now starting to expire, and the pace is expected to accelerate. This month Merck launched Europe’s first biosimilar of Roche’s breast cancer antibody Herceptin in Britain under a deal with Samsung Bioepis. More Herceptin biosimilars are set to follow this year. A biosimilar version of AbbVie’s rheumatoid arthritis drug Humira — the world’s biggest-selling medicine — is also expected later this year, and a biosimilar of Avastin, another Roche cancer drug, is expected in 2019. Britain’s NHS estimates biosimilars could save up to £300 million a year. Jatinder Harchowal, chief pharmacist at the Royal Marsden hospital and one of the coordinators of the UK’s push for biosimilar use, believes the scale of discounts achieved so far means the savings could be even higher. “These are large figures. Without compromising clinical effectiveness, this is a big saving that can be reinvested back into the NHS,” he told a news briefing. The uptake of biosimilar rituximab has been significantly faster than that of the first antibody biosimilar — a copy of Johnson & Johnson and Merck’s Remicade for arthritis — which Harchowal attributes to tendering and growing doctor confidence. Pfizer and J&J lawsuit

In the United States the key battleground remains a biosimilar to Remicade, which has sparked a high-profile legal fight between J&J and Pfizer. Pfizer, a major biosimilars player and supplier of innovative drugs, has sued J&J over its Remicade contracts with health insurers, arguing that they are anti-competitive and block sales of Pfizer’s new biosimilar. Pfizer contends that J&J is offering discounts on Remicade in exchange for essentially excluding Pfizer’s drug from insurance coverage, keeping it out of the hands of doctors and patients. J&J says Pfizer’s suit is without merit. Jenny Alltoft, Pfizer’s global head of biosimilars, told Reuters that a tilted playing field against biosimilars was a threat not only to Pfizer but also to the wider U.S. healthcare system, which is struggling with spiraling costs. “Pfizer wanted to shine a light on this with the lawsuit so that it doesn’t become common practice, because if it does, then the U.S. will never get the benefit that biosimilars could offer in terms of patient access and healthcare savings,” she said during a visit to London. The tussles in the biosimilars market are a growing focus for investors, with soaring valuations for some pioneers in the field, such as South Korea’s Celltrion, and worries about the long-term sales threat to makers of original drugs such as Roche and AbbVie. Consensus forecasts from analysts suggest that combined sales of Roche's Rituxan, Herceptin and Avastin will halve over the next five years, leaving a gap the Swiss group must fill with new drugs for cancer, multiple sclerosis and haemophilia.