Call for compulsory license for biosimilar trastuzumab emtansine

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Call for compulsory license for biosimilar trastuzumab emtansine

Biosimilares/General | Posted 23/10/2015 0 Post your comment

A pressure group, which includes both patients and doctors, has called for the UK Government to overturn patents on Roche’s breast cancer treatment Kadcyla (trastuzumab emtansine).

On 1 October 2015, The Coalition for Affordable T-DM1, a group of cancer patients, doctors and access to medicines advocates, sent a letter to the Secretary of State for Health Jeremy Hunt asking the UK Government to authorize the manufacture or importation of biosimilars of the expensive breast cancer treatment Kadcyla.

Kadcyla is used to treat late-stage breast cancer patients who test positive for human epidermal growth factor receptor 2 (HER2), a protein that causes an aggressive form of breast cancer. While Kadcyla can add about six months to the lives of some women with breast cancer, the country’s health watchdog The National Institute for Health and Care Excellence (NICE) decided not to reimburse the drug, saying that the cost of the product, which stands at 90,000 pounds per patient, is excessive. Then more recently, the UK National Health Service (NHS) said that Kadcyla would be one of a number of medicines no longer covered by the Cancer Drugs Fund starting as of November 2015.

After 4 November 2015, no new patients will be able to access Kadcyla on the NHS. NICE estimates that 1,500 women in the UK could benefit from treatment with Kadcyla every year if its cost was not so prohibitive.

Compulsory licensing is allowed under British law in special circumstances, as it is in many countries, but the manoeuver is unusual in any but developing countries. Most notably, back in 2012 India forced Bayer to grant a compulsory licence for its cancer drug Nexavar (sorafenib) in 2012 [1]. Under the UK law, the request falls under he Crown Use provisions of Section 55 of the UK Patents Act 1977 (as amended).

The group is also proposing that the UK Government challenge Roche’s test data exclusivity for T-DM1 (Kadcyla) or force the company to disclose its manufacturing processes for the drug, or fine Roche for excessive pricing. The group also proposes that these measures be extended to other expensive cancer drugs.

Although it admits that any action by the UK Government will not change the situation for patients right now, the group believe that a positive reaction ‘will likely change the reaction by Roche to longstanding requests for lower prices for T-DM1, and make it easier to obtain lower and more affordable prices in the near term’.

Reference
1. GaBI Online - Generics and Biosimilars Initiative. Bayer loses Nexavar compulsory licence appeal [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2015 Oct 23]. Available from: www.gabionline.net/Generics/News/Bayer-loses-Nexavar-compulsory-licence-appeal

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Source: Cancer Union, Reuters