Amgen is on the cusp of getting its first biosimilar approved in the U.S., a knockoff of arthritis fighter Humira, having this week won unanimous support from an FDA advisory committee. When it comes time to take the drug to Japan, the drugmaker will have a partner there to help sell it.
The Thousand Oaks, CA-based biotech today said that it and Daiichi Sankyo have struck a deal to sell 9 biosimilars in Japan, including some in late stages of development. That includes knockoffs of AbbVie’s ($ABBV) Humira, the world’s best-selling drug, as well as its versions of two Roche ($RHHBY) cancer drugs, Avastin and Herceptin.
The drugmakers didn’t share any of the financial terms of the deal, which is specific to Japan, but said that Amgen ($AMGN) will have responsibility for developing and manufacturing the products and that Daiichi Sankyo will handle the paperwork in Japan and distribute and sell the products there. Amgen will however maintain a limited right to co-promote the products.
"Amgen is excited to collaborate with Daiichi Sankyo as we seek to drive adoption and build confidence in biosimilars as a means of enhancing patient access to more affordable therapeutic options worldwide," Amgen’s biosimilars general manager Scott Foraker said in a statement.
The two did not address the fact that Daiichi Sankyo has its own biosimilar development program going, which includes working on a knockoff of Amgen’s arthritic med Enbrel. Earlier this year Daiichi announced that it and U.S.-based Coherus Biosciences ($CHRS) hit a successful Phase III mark in trials for the Enbrel biosimilar.
It is a good time to be sizing up Japan for biosimilar sales. The government is on a campaign to build the share of generic drugs to 60% by next year, more in line with Western countries. Earlier this year regulators said biosimilars can not be priced at any more than 70% of the reference drug.
Japan’s is one of the world’s largest drug markets and lots of companies want to break into it with biosimilars. India’s Biocon this year got approval there for its biosimilar of Sanofi’s ($SNY) diabetes med blockbuster Lantus. There also are other Japanese companies working on copycat drugs for the market. Japan’s Nichi-Iko Pharmaceutical, which this week announced a $736 million deal to buy Illinois-based Sagent Pharmaceuticals ($SGNT), has a pipeline of biosimilars it intends to sell in both countries.
- here’s the announcement