Study finds Amgen, Allergan's proposed biosimilar ABP 980 comparable to Roche's Herceptin

Amgen and Allergan announced top-line Phase III results Thursday showing that their proposed biosimilar ABP 980 was non-inferior to Roche's Herceptin (trastuzumab) in patients with HER2-positive early breast cancer. The companies also noted that the data "could not rule out superiority" based on the study's primary efficacy endpoint of difference in the percentage of patients with a pathologic complete response (pCR). 

The trial enrolled 725 patients diagnosed with HER2-positive early breast cancer. In the neo-adjuvant phase, after four weeks of run-in chemotherapy, patients were randomised to treatment with ABP 980 or Herceptin, both in combination with paclitaxel. In the adjuvant phase, following surgery, patients received ABP 980 or Herceptin for up to one year. Patients who received ABP 980 during the neoadjuvant phase continued to receive the biosimilar product candidate for the adjuvant phase, whereas those who had been randomised to Herceptin initially received either ABP 980 or Herceptin during the adjuvant period.

According to the companies, clinical equivalence was determined by comparing the confidence interval of the risk difference and risk ratio of the pCR in breast tissue and axillary lymph nodes using pre-specified equivalence margins.

Sean Harper, executive vice president of R&D at Amgen, said "we believe this study confirms no clinically meaningful differences between ABP 980 and [Herceptin], and we look forward to continued discussions with regulatory authorities." Harper added "we believe that the totality of the evidence we've generated supports ABP 980 as highly similar to the reference product." 

Amgen and Allergan, previously known as Watson Pharmaceuticals, are developing ABP 980 under the terms of a 2011 agreement to collaborate on four oncology antibody biosimilars. Last September, the companies announced late-stage study data illustrating that the investigational biosimilar APB 215 was clinically equivalent to Roche's Avastin (bevacizumab) in treating adults with advanced non-squamous non-small-cell lung cancer. 

Amgen is developing a total of nine biosimilars, including ABP 501, a proposed biosimilar of AbbVie's Humira (adalimumab). Earlier this month, an FDA advisory panel unanimously backed approval of ABP 501 for seven chronic inflammatory conditions for which Humira is authorised. In addition, Amgen recently entered into a partnership with Daiichi Sankyo to commercialise biosimilars in Japan. Allergan is also separately developing biosimilars.

Meanwhile, Mylan and Biocon said results presented at the recent ASCO conference from the late-stage HERITAGE study confirmed the efficacy and safety of their follow-on version of Herceptin, MYL-1401O.

For related analysis about the biosimilars market, see The Future of Biosimilars 2016​​​.



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