The UK’s High Court has overturned two patents protecting Roche’s breast cancer drug Herceptin from generic competition, setting up the launch of first biosimilar competition later this year.
The primary patent for Herceptin (trastuzumab) expires in Europe on July 28, 2014, and biosimilar developer Hospira was the company that filed the suit against two others – covering dosage forms and compositions – that extended the protection from biosimilar competition.
Victory in the lawsuit means that Hospira and South Korean partner Celltrion now intend to launch a biosimilar as soon as the primary patent of the $6.9bn-a-year blockbuster expires.
If that occurs the two companies will have two biosimilar monoclonal antibodies on the market in Europe, having secured approval for Inflectra/Remsima, a copycat version of Johnson & Johnson’s and Merck & Co’s Remicade (infliximab) last year.
Roche has remained tight lipped on the matter, saying it was analysing the ruling and considering its options. European sales accounted for a little over $2.5bn of Herceptin’s turnover last year, with the UK making up a fraction of that total.
Meanwhile, Roche is in the midst of a battle to block the launch of Biocon and Mylan’s biosimilar Canmab/Hertraz product in India, while Celltrion has already introduced its own version of the drug – called Herzuma – in its home market at a 30 per cent discount to the original brand.
Last September Roche secured EU approval for a new subcutaneous formulation of the drug, which is easier and quicker to administer than the previous intravenous infusion and could help defend the franchise from generic competition. The company is also trying to shift patients from Herceptin to other HER2-targeting drugs in its portfolio, notably new antibody drug conjugate (ADC) Kadcyla (trastuzumab emtansine).
A recently-published report by Frost & Sullivan suggests the global biosimilars market will rise from just $1.2bn last year to $23bn in 2019.