Amgen, Allergan clear Phase III with Herceptin biosimilar

Amgen ($AMGN) has big biosimilar goals for this year. Fresh off a positive FDA panel earlier this month for what could be its first approved biosimilar for Humira (adalimumab), now the biotech and partner Allergan ($AGN) have reported positive top-line Phase III data for a Herceptin (trastuzumab) biosimilar to treat breast cancer.

It’s hoping for an FDA approval this year for the Humira biosimilar, which has a Sept. 25 FDA review date. And also plans to submit to the FDA for its Avastin (bevacizumab) biosimilar, for which it reported positive Phase III data last year.

Those are all of Amgen’s late-stage biosimilar programs; it has another three disclosed ones in development, with a final three that are as yet undisclosed.

The FDA approved its first biosimilar last year, Zarxio (filgrastim-sndz) from Novartis’ ($NVS) Sandoz, a version of Amgen’s Neupogen. In April, the agency also approved Inflectra (infliximab-dyyb) from Pfizer ($PFE), a version of Johnson & Johnson’s ($JNJ) Remicade.

The top-line Phase III data from Amgen and partner Allergan ($AGN) for the Herceptin biosimilar showed that it was non-inferior to the original drug--and that superiority could not be ruled out, the partners said.

"We believe this study confirms no clinically meaningful differences between ABP 980 and trastuzumab, and we look forward to continued discussions with regulatory authorities," said Amgen EVP of R&D Dr. Sean Harper in a statement. "Biosimilars are approved based on the analytical, nonclinical and clinical data, and we believe that the totality of the evidence we've generated supports ABP 980 as highly similar to the reference product."

In the 725-patient study, about half were randomized to the Herceptin biosimilar (ABP 980) and half to trastuzumab to treat human epidermal growth factor receptor 2-positive (HER2-positive) early breast cancer. About 20% of breast cancers are HER2-positive--and they tend to be more aggressive.

The Herceptin biosimilar is part of a partnership that Amgen formed with Watson Pharmaceuticals in 2011. Watson is now known as Allergan. The pair partnered to develop and commercialize four oncology antibody biosimilars worldwide.

"These results provide significant clinical evidence that ABP 980 could be an important biosimilar treatment option for patients with HER2-positive early breast cancer," said David Nicholson, chief research and development officer at Allergan.

- here is the announcement

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