Amgen targets China in cancer biosimilar development deal with Simcere
September 27, 2017

Even as it battles against knockoffs of its own biologic drugs, Amgen is steadily growing its own biosimilar portfolio of copies of some of the bestselling cancer and inflammation drugs. Now, with a co-development deal with Simcere, Amgen is taking that effort to China, a country relying heavily on copycat drugs.

The exclusive agreement includes four undisclosed biosimilars in oncology and inflammation, all existing ones in Amgen’s portfolio, according to a joint statement put forward by the two companies.

Amgen will be responsible for development, filing for approval from China’s FDA and manufacturing of the biosimilars, while Simcere will take care of distribution and commercialization in its home country.

Scott Foraker, VP and GM of Amgen Biosimilars, said the company picked Simcere because of its “local development experience and strong commercial presence in China in the areas of inflammation and oncology.”

The Nanjing-based company formed a biopharmaceutical unit in 2015, focused exactly on those areas, according to the company’s website. The subsidiary currently has 33 employees and a portfolio that includes lung cancer med pemetrexed, skin cancer implants fluorouracil and chemotherapy nedaplatin.

Although the exact meds and financial terms were not disclosed, one might as well take a guess based on Amgen’s existing pipeline.

First, there’s already FDA-approved Humira copycat Amjevita, whose launch in the U.S. has been delayed by a patent infringement suit brought by a AbbVie. Just a few days ago, Amgen and partner Allergan gained an FDA nod for a biosimilar of Roche’s Avastin. Back at the end of July, the pair’s application for a Herceptin biosimilar was accepted by the agency for evaluation. Then, there are also copycats for Roche’s Rituxan and Janssen’s Remicade under development in Amgen’s pipeline.

All three Roche meds—Avastin, Rituxan and Herceptin—were just recently added to China’s National Reimbursement Drug List after big price cuts as a result of negotiations with the Chinese government, meaning that the country’s national medical insurance will help cover their costs. Simcere’s own cancer med endostatin was also among the 36 drugs included, and Remicade was one of eight that ended up with no-deals.

To reach those deals with the government, drugmakers have made careful calculations to balance the degree of discount they’re willing to take with a potentially wider patient base that might make up for overall sales.

Source: FiercePharma

Related: FDA commish cheers on biosimilars as Amgen, Allergan score OK for knockoff of Roche’s Avastin