Hospira ($HSP) is one step closer to selling a Herceptin biosimilar in Britain. The U.S.-based drugmaker persuaded a U.K. court to overturn two Roche ($RHHBY) patents on the drug. And that means, as of now, Herceptin (trastuzumab) could be open to biosim competition when its main patent expires July 28.
Roche's top-selling breast cancer drug, Herceptin brought in $6.93 billion for the Swiss drugmaker last year, Bloomberg notes. A treatment for HER2-positive tumors, Herceptin will first be vulnerable to competition in the developed world in Europe, with that July 28 patent expiration. U.S. exclusivity is set to expire in 2019.
Meanwhile, in January, the South Korean drugmaker--and Hospira partner--Celltrion nabbed approval in its home country for a Herceptin biosim, Herzuma. At the time, Celltrion said Herzuma would sell for 70% of the price of the Roche original.
Herceptin is already facing a potential copycat in India, where the Swiss drugmaker gave up its patent fight last year. The domestic drugmaker Biocon, in partnership with U.S.-based Mylan ($MYL), said they were ready to roll on a Herceptin biosimilar in India in December. Roche has fought back since, however, by suing the two companies and Indian regulators, alleging that the biosim approval violated the country's approval guidelines.
Celltrion and Hospira have teamed up to develop eight copycat biotech drugs, including the Herceptin knockoff. The partnership has already yielded a European OK for the blockbuster anti-inflammatory treatment Remicade, which Hospira is marketing in Europe under the brand name Inflectra.
But Roche could end up with a piece of Hospira's biosimilar Herceptin business. Celltrion's chairman has been taking bids for his $1.3 billion stake in the company--and Roche is one of the major drugmakers looking at the deal, according to media reports. Teva Pharmaceutical Industries ($TEVA) and AstraZeneca ($AZN) are both said to be mulling bids, too.
- read the Bloomberg story