Biosimilars, Licensing

Shire punts late-stage biosimilars of Humira and Enbrel back to Momenta, Coherus

Momenta CEO Craig Wheeler

Momenta CEO Craig Wheeler

Just days after Amgen won an FDA approval for the first biosimilar of AbbVie’s Humira, Shire $SHPG has decided to throw away its partnership rights in a rival program now in Phase III. Shire simultaneously cut loose of a separate deal with Coherus $CHRS on developing an Enbrel biosimilar, which was also inherited in its Baxalta acquisition.

Cambridge, MA-based Momenta Pharmaceuticals says Shire is handing back rights to M923, one of several copycats of the megablockbuster autoimmune drug. But Shire remains on the hook for its share of the development costs for another year, which may well take this drug right up to an FDA application. Coherus, meanwhile, says that it has successfully navigated a pair of Phase III studies for CHS-0214 and will now recognize $162.6 million as collaboration and license revenues in 2016.

Momenta has wound down a long road littered with successive partners since it originally signed a $452 million deal in 2011 to collaborate with Baxter on the then nascent field of biosimilars. Shire picked up those rights when it bought out Baxalta, which was spun out of Baxter.

Shire’s prime interest in Baxalta, though, had to do with its drugs for rare diseases, which fits well into its own strategy. And Shire’s cast-off is Momenta’s treasure in the lead-up to Phase III results before the end of this year.

“We view Shire’s decision as a significant opportunity for us to capture additional value from this program for the Company and its shareholders,” said Momenta CEO Craig Wheeler.

AbbVie has plenty to gain and much to lose when it comes to Humira and the biosimilar market. The company earned about $14 billion off the franchise last year, and the numbers keep headed north. In the second quarter, its flagship drug brought in $4.15 billion. Humira provides roughly two-thirds of its revenue and AbbVie has been fighting for time — lots more time, any means necessary — to develop new drugs to take its place. The company has said that it can fight off any biosimilar arrivals for another six years.

Amgen, meanwhile, will be pushing to get their biosimilar — dubbed Amjevita — on the market sometime next year, hoping once the main patent lapses in December they can fight their way out front. Meanwhile, Merck/Samsung Bioepis, and Novartis also have knockoffs in the clinic, looking to line up for a share of the market as well.

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Sr. Manager, Regulatory Affairs, CMC
CytomX Therapeutics San Francisco, CA
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Catalytic Data Science Charleston, SC
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Flatiron Health New York City or San Francisco

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