Partners Amgen ($AMGN) and Allergan ($AGN) say their knockoff of Roche's ($RHHBY) blockbuster Avastin proved itself on par with its reference product, putting the pair a step closer to biting into the cancer drug's billions in annual revenue.
The biosimilar, ABP 215, measured up to Avastin in a Phase III trial involving 642 patients with non-small cell lung cancer (NSCLC), Amgen and Allergan said. ABP 215 met its primary endpoint of clinical equivalence by shrinking tumors at a rate comparable with Roche's drug, the companies said, and the copycat treatment came through with a matching safety profile.
The goal is to eventually compete with a cancer treatment that brought in about $6.6 billion for Roche last year, a 6% increase over 2013. Amgen believes the positive NSCLC study will eventually support ABP 215's approval in all 6 cancers for which Avastin is already indicated, allowing the biosimilar to hit the ground running once it hits the market. But Amgen and Allergan will have to wait until Avastin's patents run out, not expected until 2019 in the U.S. and 2022 in Europe.
The latest Phase III success marks a clinical victory for Amgen and Allergan's biosimilar partnership, which began in 2011 and aims to develop four knockoffs of top-selling cancer treatments. Under the agreement, Amgen is tasked with the heavy lifting of development and manufacturing, and Allergan, then Watson Pharmaceuticals, signed on to assist in commercialization in exchange for royalties and milestone payments tied to sales.
Amgen's embrace of biosimilars comes as many of its banner products face patent-cliff pressures of their own. Neupogen, Amgen's multibillion-dollar neutropenia treatment, became the target of the U.S.'s first-ever biosimilar when Novartis ($NVS) launched a copy called Zarxio earlier this month. And a bevy of developers have sights set on Enbrel, Amgen's biggest cash cow.
Playing defense, Amgen is moving through clinical development with in-house versions of AbbVie's ($ABBV) Humira, Roche's Herceptin, Johnson & Johnson's ($JNJ) Remicade and other blockbuster medicines coming off patent.
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