Baxalta and Momenta target Humira with a Phase III biosimilar trial

Baxalta R&D Chief John Orloff

Partners Baxalta ($BXLT) and Momenta Pharmaceuticals ($MNTA) are setting sights on the world's top-selling drug with a biosimilar of their own, moving into Phase III with a copy of AbbVie's ($ABBV) cornerstone medicine.

The two companies, working under a 2011 alliance, kicked off a pivotal trial for M923, their version of AbbVie's blockbuster Humira, testing whether it can stack up to its reference product in improving symptoms of chronic plaque psoriasis. If all goes according to plan, Baxalta and Momenta said they'll be ready to submit M923 for regulatory approvals in 2017 and launch the injection the following year.

Humira, approved for a range of autoimmune diseases, brought in about $12.5 billion for AbbVie last year, accounting for more than 60% of the drugmaker's total revenue. But the patents protecting Humira from biosimilar competition are set to expire at the end of 2016, and a growing number of would-be rivals are queuing up to compete.

Baxter ($BAX), Baxalta's progenitor, tapped Momenta for help getting into biosimilars four years ago, paying its partner $33 million up front and promising up to $419 million more tied to development and commercial milestones in a collaboration that covers as many as 6 projects. Baxalta is already in Phase III with an in-house version of Amgen's ($AMGN) Enbrel, which competes with Humira.

Baxalta and Momenta are hardly the only contenders coming after AbbVie's cash cow. Merck ($MRK), working with Samsung Bioepis, posted positive Phase III data for a Humira copy over the summer, plotting global regulatory filings. And similar programs are underway at Novartis ($NVS), Amgen and elsewhere.

As for AbbVie, the company has been working to soften the eventual blow of Humira's patent expiration. Earlier this year, AbbVie paid a whopping $21 billion for Pharmacyclics and its 50% share of Imbruvica, a Johnson & Johnson ($JNJ)-partnered blood cancer treatment the company believes can keep racking up approvals and growing its market share. And, in hepatitis C, AbbVie scored a major victory with the 2014 approval of Viekira Pak, a rival to Gilead Sciences' ($GILD) blockbuster Harvoni.

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