Mylan and its partner, Biocon, announced strong results from a Phase III trial for a biosimilar (MYL-1401O) of Roche’s blockbuster biologic breast cancer treatment, Herceptin. A thumbs up from the FDA would mean a financial boon for Mylan and Biocon as well as a good sign for other companies pursuing biosimilar approval since only two biosimilars are currently approved for use in the US. In addition, HER2-positive breast cancer patients would also reap the financial benefits of a biosimilar treatment. While efficacy and safety are comparable between branded Herceptin and MYL-1401O, the biosimilar would be offered at a more affordable price point which should please patients and payers alike. Roche, we imagine, would be less than thrilled.