Simcere and Amgen will take joint responsibility for the co-development of the products in China, which includes getting marketing approval from the CFDA, manufacturing, distribution and commercialization.
The names of the biosimilar products remain undisclosed, but both parties have confirmed that they would fall within the areas of inflammation and oncology. The chosen products all come from Amgen's existing biosimilars portfolio, which includes adalimumab, trastuzumab, bevacizumab, rituximab, infliximab and cetuximab.
Financial terms were also not disclosed.
Alan Yuan, vice president at Nanjing-based Simcere, told BioWorld Asia that the chosen products are at various stages of development, with some already having "proven efficiency and strong performance" in other markets and others just in phase I trials.
"We expect the first product to hit the market in about two to three years, pending approval from the CFDA," said Yuan. "But it could be even sooner as the CFDA already started improving its approval system to meet the amount of applications coming its way."
Yuan said that Simcere is the "first and so far, the only partner" for Amgen's biosimilars in the Chinese market. But Amgen, of Thousand Oaks, Calif., has been teaming up with other partners to find its footing in different sectors within the region, such as its biosimilars agreement with Daiichi Sankyo Co. Ltd. in Japan.
Honggang Feng, president of Simcere, said the collaboration will also serve to "help accelerate the development and launch of U.S.- or Europe-approved biosimilars in China."
"By leveraging our sales network, it will also help to improve the accessibility of high-quality therapeutic antibodies for Chinese patients," he said. "This collaboration will also allow both companies to further penetrate inflammation and oncology markets in China."
On June 19, China officially joined the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) and streamlined regulations surrounding drug evaluation and approval systems to encourage and support innovative drug R&D. Both will likely to shorten the time for Chinese patients. (See BioWorld, June 28, 2017.)
"We want to develop and introduce biosimilars of a quality that meets both global and the rising Chinese standards," said Yuan.
Amgen is the world's sixth-largest independent biopharma company with a market cap of about $126.7 billion and $23 billion in revenue last year.
Simcere is focused on therapeutic areas such as oncology, neurology, inflammation and immunology, and cardiovascular and infectious diseases.
The Chinese biologics and biosimilars market has been experiencing significant growth, expanding in double digit percentages over the last decade. However, the lagging regulatory system has always been criticized by international drug developers.
"Biologics are increasingly being sold to Asia, as China and Japan are using more biologics to treat their aging populations. In terms of the biologics market, I wouldn't say that there [are] more challenges in China compared to anywhere else in the world, as China has a very strong regulatory system, but historically it has taken longer to get biologics approved by the CFDA," David Stanton, regional head of health care research at investment firm CLSA, told BioWorld Asia.
Some observers said the market has faced a glut of entries looking to ride on the biosimilar wave, which could overshadow products of high quality and efficacy.
"Domestic biosimilar is already overcrowded. Opportunities can be really bottom-up instead of top-down. Some unique formats and functions for drugs to improve are the major focuses for pharma specialty funds currently in China," said Eugene Huang, China health care analyst at Jefferies.
Yet, Yuan remains optimistic about the need for biosimilars in China.
"Biologics remain a very expensive and out-of-reach option for a lot of Chinese patients. Biosimilars offer patients the same therapeutics at a more accessible cost. The global standards of Amgen's biosimilars also makes us feel confident about their prospects in the Chinese market despite the competition," he said.
Simcere's biopharma venture, Simcere Bio-pharmaceutical Technology Co. Ltd. was established in 2015. With 33 employees, it specializes in developing innovative drugs of cancer, immunology and infectious diseases.