Amgen to work with Daiichi Sankyo on 9 biosimilars in Japan


Tokyo-based Daiichi Sankyo has greatly expanded its reach into biosimilars--as its top-selling drug faces patent expiry--in Japan in a sales and marketing deal with Amgen ($AMGN) for 9 products.

For Amgen, the pact comes fresh off a nod by the U.S. FDA for a biosimilar of AbbVie ($ABBV) blockbuster Humira (adalimumab)‎‎ and gives the company new footing in the major reimbursement market in Japan where Takeda Pharmaceutical recently scaled back an R&D alliance with the California-based firm. Details and financial terms of the deal with Daiichi Sankyo were not disclosed.

According to a press release, the deal includes approved and late-stage development biosimilars of adalimumab, bevacizumab (Avastin) and trastuzumab (Herceptin).

But Amgen has already released details of its biosimilar program that include oncology therapies rituximab (Rituxan), cetuximab (Erbitux) and infliximab (Remicade)--though neither company confirmed those therapies as part of the deal.

The first biosimilar approved in Japan was infliximab in 2015 and the government has stated it wants a wider mix of generics and biosimilars in its reimbursement program to trim costs.

"Under the terms of the agreement, Amgen will remain responsible for the development and manufacturing of the biosimilars. Daiichi Sankyo will file for marketing approval and be responsible for distribution and commercialization in Japan, while Amgen will have a limited right to co-promote the products," according to the release.

Amgen said it retains distribution and commercialization rights for the biosimilars outside of Japan.

In January, Daiichi Sankyo and U.S.-based Coherus Biosciences ($CHRS) hit a successful Phase III mark in trials for a biosimilar of Amgen's rheumatoid arthritis therapy Enbrel (etanercept)--with plans by the Tokyo-based firm to market approved products in Japan, South Korea and Taiwan under a 2012 agreement.

Daiichi Sankyo faces the patent loss of Benicar (olmesartan) and has been in the process of rejigging its cost structure and R&D plans to face the challenge, though other firms in Japan are following similar strategies such as Nichi-Iko Pharmaceutical which just snapped up Sagent ($SGNT) in the U.S. for $736 million.

- here's the release

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