No Clinically Meaningful Differences Between Herceptin and Amgen/Allergan Biosimilar

Amgen is at it again with biosimilars. Amgen and Allergen’s version of Herceptin (trastuzumab) demonstrated in Phase III clinical trials to be noninferior to Genentech’s (Roche’s) branded version of the drug. Although the investigational candidate ABP 980 was not found to be superior to Roche’s blockbuster drug, it was determined to be comparable in efficacy, immunogenicity, and instances of adverse events. Herceptin is approved for the treatment of early-stage HER2-positive breast cancer, metastatic breast cancer, and gastric cancer.

ABP 980 is a humanized monoclonal antibody (mAb) that has the same dosage strength as Herceptin and the same amino acid sequence. It is one of the four oncology biosimilars that Amgen and Allergen are developing together. Roche's Herceptin will face patent expiration in 2019 in the United States.

Roche reported that in 2015, the 5% in increase in its pharmaceutical sales was partially due to sales for Herceptin and that the drug was a "strong growth driver" for the year. According to an investor update on July 21, 2016, Roche's overall profit for cancer drugs rose 4% in the first half of 2016, and Herceptin sales grew 5% during the same period.

The company said Herceptin sales growth was driven by increased demand for the drug and longer duration of treatment in combination with Perjeta. Herceptin and Perjeta are currently being tested in three Phase III clinical trials for other indications. Herceptin, Perjeta, and Kadcyla were among the strongest growth drivers targeting HER2-positive breast cancer, driving a combined 10% of sales for Roche in the first half of 2016.

Sources: Roche, Amgen