Amgen partners with Daiichi on biosimilars after positive FDA panel


An FDA panel gave Amgen a thumbs up earlier this week for its biosimilar version of AbbVie’s ($ABBV) Humira (adalimumab), which is the world’s biggest drug blockbuster. Now, the biopharma has struck a marketing partnership for adalimumab--and 8 other biosimilars--with Daiichi Sankyo in Japan.

Two FDA panels gave positive recommendations for biosimilars this week, the second for a biosimilar of Amgen’s ($AMGN) own Enbrel (etanercept) by Novartis ($NVS). That makes Amgen an intriguing test case in the midst of the unfolding of the economics of biosimilars as companies work to effectively balance the development costs, biosimilar pricing and the demand for more reasonably priced drugs.

Last spring, Novartis’ Sandoz nabbed the first FDA approval for a biosimilar with its Zarxio (filgrastim-sndz), a version of Amgen’s long-standing product Neupogen (filgrastim).

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This year, Amgen expects to make big strides itself on the biosimilar front--gaining an approval for its Humira biosimilar, as well as submitting to FDA for its Avastin (bevacizumab) biosimilar and revealing Phase III data for its biosimilar of Roche’s ($RHHBY) Herceptin (trastuzumab). The Humira biosimilar has a Sept. 25 date for FDA review.

The Daiichi Sankyo deal is an exclusive partnership to commercialize 9 biosimilars in Japan--including all of Amgen’s late-stage biosimilars: adalimumab, bevacizumab and trastuzumab.

Daiichi will file for regulatory approval in Japan. The company will also be responsible for marketing and distribution in Japan, with Amgen retaining limited, undisclosed co-promotion rights. Amgen will continue to be responsible for the clinical development and manufacturing of the biosimilars.

"We seek to drive adoption and build confidence in biosimilars as a means of enhancing patient access to more affordable therapeutic options worldwide," summed up Amgen VP and GM of Biosimilars Scott Foraker in a statement.

In addition to its three most advanced biosimilars, Amgen has also disclosed development on biosimilars for Rituxan (rituximab), Remicade (infliximab) and Erbitux (cetuximab). Its remaining three biosimilar programs are undisclosed.

- here is the release

Related Articles:
Novartis gains FDA panel thumbs up for Amgen Enbrel copy
FDA panel backs Amgen’s Humira copy, but don’t expect to see it anytime soon
Amgen fails to block Novartis' Neupogen biosimilar


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