In 2013, Amgen formed a strategic alliance with Astellas Pharma (Astellas), a Japanese multinational pharmaceutical company. The joint venture has launched three drugs since this time, all of which are monoclonal antibodies:

• Repatha (evolocumab), a treatment for high cholesterol levels
• Evenity (romosozumab), a treatment for osteoporosis which reduces the risk of spinal fracture
• Blincyto (blinatumomab), a second-line treatment for a form of acute lymphoblastic leukaemia

At the JP Morgan healthcare conference in San Francisco, Amgen announced plans to dissolve the joint venture with Astellas in order to operate the unit independently.

The change will take place on 1 April 2020, at which point Amgen will purchase the 49% of shares in Amgen Astellas Biopharma that are currently held by Astellas. This will make Astellas a wholly-owned Amgen affiliate. The new company will be named Amgen KK and will have headquarters in midtown Tokyo.

The move reflects Amgen’s progression in the Asian market. The company expects a quarter of its growth in the next decade to come from the continent, according to Chief Executive Robert Bradway.

‘China and Japan are the second and third largest markets in our industry’, Bradway said. ‘In the case of China, it is a rapidly growing market ... Japan has an ageing population and we expect that will be a growth market for us’, he continued.

Amgen KK and Astellas will continue to co-promote the three drugs developed by the joint venture, and Astellas will remain responsible for their distribution and sales beyond 2020.

This is not the only venture Amgen has in Asia. In 2016, the company made a deal with Japan-based Daiichi Sankyo for biosimilars in Japan [1]. Then in 2017, the company made an agreement with China-based Simcere Pharmaceutical Group to co-develop and commercialize four copy biologicals in China [2].

Editor’s comment
It should be noted that copy biologicals approved in China might not have been authorized following as strict a regulatory process as is required for approval of biosimilars in the European Union. The EMA (European Medicines Agency) regulatory requirements ensure the same high standards of quality, safety and efficacy for biosimilars as for originator biologicals, and also include a rigorous comparability exercise with the reference product.

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Biosimilars approved in Japan

References
1. GaBI Online - Generics and Biosimilars Initiative. Amgen and Daiichi Sankyo make deal for biosimilars in Japan [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2020 Mar 6]. Available from: www.gabionline.net/Pharma-News/Amgen-and-Daiichi-Sankyo-make-deal-for-biosimilars-in-Japan
2. GaBI Online - Generics and Biosimilars Initiative. Amgen and Simcere to collaborate on copy biologicals in China [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2020 Mar 6]. Available from: www.gabionline.net/Pharma-News/Amgen-and-Simcere-to-collaborate-on-copy-biologicals-in-China

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