Amgen and Allergan are reporting a new success for their partnership aimed at developing a slate of four big biosimilars. Investigators reported that ABP 980 was virtually indistinguishable from Roche’s $6.5 billion franchise drug Herceptin (trastuzumab) in patients with human epidermal growth factor receptor 2-positive (HER2-positive) early breast cancer in a Phase III trial.
The results set up another shot at a near-term approval, following Amgen’s solo success in front of an FDA panel review a week ago for its biosimilar of AbbVie’s $14 billion franchise drug Humira. A day later Amgen was playing defense, trying to slow Novartis’s effort to win an approval for a biosimilar of Enbrel, a $9 billion gold mine for Amgen and its partners.
There have been some setbacks in the field, including one earlier this week when Novartis revealed that the FDA had issued a CRL for their biosimilar of Neulasta. But evidence has been mounting that a pioneering approval last year has set the stage for a rollout of a new wave of cheaper generic biologics over the next four years. The main impediment now: lawsuits filed over patents and applications, aimed at scuttling the competition.
Amgen alone has a slate of biosimilars in the pipeline. Allergan also has its own programs in the works as well.
Sean E. Harper, M.D., executive vice president of Research and Development at Amgen, offered this in prepared text:
We believe this study confirms no clinically meaningful differences between ABP 980 and trastuzumab, and we look forward to continued discussions with regulatory authorities. 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.
The partners also reported the success of their biosimilar of Avastin in a Phase III last fall.
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