Originator biologicals and biosimilars under attack in UK and Japan

Biosimilars/General | Posted 26/10/2018 post-comment0 Post your comment

Originator biologicals makers and biosimilars makers are finding themselves facing litigation in both the UK and Japan.

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German Pharma Giant Bayer has said that it is going to challenge a ruling by the UK’s high court that it was lawful for National Health Service (NHS) organizations to use a cheaper off-licence substitute instead of the more expensive alternatives. The court ruled that the NHS could offer patients Avastin (bevacizumab) injections for the treatment of wet age-related macular degeneration (AMD) in place of two licensed but much more expensive treatments, Bayer’s Eylea (aflibercept) and Lucentis (ranibizumab), made by Novartis.

Although Roche’s Avastin is not licensed for wet AMD, an independent trial by the US National Institutes of Health in 2012 found that Avastin was as effective as Lucentis in treating wet AMD, although serious adverse events were slightly more common with the Roche drug than with Lucentis.

The reason the NHS wants to switch is to save money. Lucentis costs GBP 561 per injection and Eylea costs GBP 800, compared to Avastin, which costs only around GBP 28 per injection. Switching to off-licence Avastin is estimated would save the NHS GBP 100 million or more, if applied across the whole of England.

Bayer said that it believed that ‘Mrs Justice Whipple’s conclusions are wrong in a number of key respects’ and that it ‘intends to seek permission to appeal her judgment to the Court of Appeal’.

Meanwhile, in Japan, Chugai Pharmaceutical (Chugai) announced on 12 October 2018 that it was bringing lawsuits against both Daiichi Sankyo and Pfizer with respect to their trastuzumab biosimilars.

Chugai is the exclusive licence holder in Japan for Roche/Genentech’s originator biological Herceptin (trastuzumab). The company is claiming that Daiichi Sankyo and Pfizer’s trastuzumab biosimilars infringe on the application patent owned by Genentech, which is a co-plaintiff in the lawsuit.

Trastuzumab is a monoclonal antibody that interferes with the human epidermal growth factor receptor 2 (HER2)/neu receptor. In some cancers, notably certain types of breast and gastric cancers, HER2 is overexpressed, and causes cancer cells to reproduce uncontrollably. Trastuzumab is therefore used to treat certain breast and gastric cancers.

Daiichi Sankyo and Pfizer gained approval for their trastuzumab biosimilars from Japan’s regulatory agency, the Ministry for Health Labour and Welfare (MHLW) in September 2018. Pfizer also received approval for its trastuzumab biosimilar Trazimera (PF‑05280014) in Europe in July 2018 [1].

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1. GaBI Online - Generics and Biosimilars Initiative. Adalimumab and trastuzumab biosimilars gain EC approval [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2018 Oct 26]. Available from: www.gabionline.net/Biosimilars/News/Adalimumab-and-trastuzumab-biosimilars-gain-EC-approval

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Source: Bayer, Chugai, NIH, Pharma Japan

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