2 patents down, 1 to expire: Herceptin biosimilar coming to EU

April 11, 2014 12:03 PM

Hospira’s U.K. unit won a court ruling overturning two patents for Roche’s top-selling breast-cancer drug Herceptin, paving the way for the company to sell a biosimilar version in the country.

The primary patent on Herceptin expires on July 28, 2014 in Europe. Hospira was seeking to invalidate two additional protections that relate to the dosages and composition of the drug. Justice Colin Birss ruled both patents, owned by Roche’s Genentech unit, were invalid in a ruling yesterday in London.

The decision erodes Roche’s exclusivity for the treatment in the U.K. and opens the door for Hospira to begin selling its own version which was developed by Celltrion. The breast and stomach cancer biologic generated 6.08 billion Swiss francs ($6.93 billion) for Switzerland-based pharma giant Roche in 2013 and has helped it become the world’s biggest maker of cancer drugs and diagnostic tests.

Herceptin which was developed by Genentech, was first approved in the U.S. in 1998 for breast cancer that has spread to other areas of the body and has been a huge success. Worldwide sales of the drug were 49 billion Swiss francs from 1999 to 2013, including European sales of 8 billion Swiss francs from 2010 to 2013, according to the suit.

Roche will begin to lose its exclusive rights to Herceptin as its first patent for the medicine expires in Europe this year and in the U.S. in 2019. The medicine boosted survival for the 20 percent of women whose breast tumors have a gene mutation that leads to extra proteins known as HER2 being generated from their cancer cells.

Hospira’s South Korean partner Celltrion recently got the approval in its home country for biosimilar Herceptin which will have a trade name, Herzuma.

Herceptin biosimilar (or an intended copy) is already launched in India. Roche gave up its patent fight last year and the local biologics player Biocon, in partnership with Mylan got the approvals from DCGI. Since then, Roche is fighting with both companies, as well as the regulatory body, stating that the approval is violating the guidelines in India.

Celltrion and it’s partner Hospira in Western Europe, will be able to launch Herceptin biosimilar after getting the regulatory approval from EMA. Latest reports state that, there are no submissions yet but both companies will seek approval within 2014.

Roche, to defend their Herceptin business, developed subcutaneous version of the biologic and also got two more approvals for new generation drugs, Perjeta and Kadcyla.

Source: Bloomberg, reports

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