- Amgen and Allergan said Thursday a Phase 3 trial of their biosimilar version of Roche's cancer drug Herceptin showed no 'clinically meaningful differences' between the two medicines.
- One of Roche's mainstay biologic drugs, Hercpetin is approved to treat HER2-positive breast cancer in combination with chemotherapy, metastatic HER2-positive breast cancer and certain types of gastic cancer. Roughly 20% of all breast cancers are HER2-positive.
- Roche's Genentech unit helped pioneer the expansion of personalized medicine with Herceptin, which was approved in 1998. Herceptin generated 6 billion Swiss Francs ($6.1 billion) in revenue last year.
With growing expertise in biologics development, Amgen has been one of several Big Pharma companies hoping to capitalize on the expiry of patent protection for several blockbuster biologic drugs, such as Herceptin.
In this case, Amgen and Allergan said their study proved comparable efficacy, safety and tolerability between ABP 980 and Herceptin based on results comparing the two drugs in 725 women wth HER2-positive early breast cancer.
The positive news comes a week after an FDA advisory paenl gave Amgen's biosimilar version of AbbVie's Humira a thumbs-up, suggesting a likely approval down the road. Even as it tries to fend off biosimilar challengers to its own biologic drugs, Amgen is aggressively developing a biosimilars pipeline and aims aims to have five biosimilars on the market by 2019.
"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 Sean E. Harper, head of R&D at Amgen.
Amgen and Allergan in 2011 agreed to jointly develop and commercialize four oncology antibody biosimilar drugs. Amgen is responsible for development and manufacturing, along with initial sales.