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Amgen and Daiichi Sankyo Team Up for Biosimilars in Japan

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Amgen Inc. (AMGN - Free Report) announced an exclusive agreement with Daiichi Sankyo Company, Limited for the commercialization of nine biosimilars in Japan including biosimilars of AbbVie’s (ABBV - Free Report) Humira and Roche Holding AG’s (RHHBY - Free Report) Avastin and Herceptin.

The deal with Daiichi Sankyo will see Amgen taking responsibility for the development and manufacturing of the biosimilars. While Daiichi Sankyo will file for marketing approval and will also be responsible for the distribution and commercialization in Japan, Amgen will have a limited right to co-promote the products. However, Amgen will hold all additional distribution and commercialization rights for the biosimilar programs outside Japan. Specific financial terms of the agreement were undisclosed.

We note that the FDA’s Arthritis Advisory Committee has voted in favor of an approval of Amgen’s ABP 501, a biosimilar version of Humira. The recommendation did not come as a surprise given the favorable briefing documents that were released by the FDA ahead of the panel meeting. The advisory panel’s opinion will now be reviewed by the FDA, with a final response on the approval status of ABP 501 expected by Sep 25.

The approval of ABP 501 would be a huge boost for Amgen considering the commercial potential of Humira and the fact that Amgen itself is facing biosimilar competition for a few of its key products (like Neupogen). However, patents covering Humira should protect the drug from competition through at least 2022.

Biosimilar threats facing Amgen have gotten more intense with the FDA’s Arthritis Advisory panel backing Sandoz’s biosimilar version of Amgen’s blockbuster drug, Enbrel. Sandoz is Novartis AG’s (NVS - Free Report) generic arm.

The race to develop biosimilars is heating up with a host of pharmaceutical and biotech companies in fierce competition.

Amgen is a Zacks Rank #3 (Hold) stock. Roche is a better-ranked stock in the health care sector, carrying a Zacks Rank #2 (Buy).

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