How quick was that, page-8

One way of knowing for sure whether HER-Vaxx is superior to Herceptin - at some point after a successful Phase 11 - is to run a clinical trial, half patients randomised to HER-Vaxx and half to Herceptin.

Amgen and its partner Allergan have done just that with their Herceptin biosimilar. They have reported positive top-line Phase 111 data for a Herceptin biosimilar to treat breast cancer. In the Phase 111, 725 patient study, half were randomised to the Herceptin biosimilar (ABP 980) and half to Herceptin (trastuzumab). And the results!

Amgen believe that the study confirms that there are no clinically meaningful differences between ABP 980 and trastuzumab - in biotech talk it was non-inferior to the original drug.

All that effort to develop a biosimilar drug with its patently obvious patent issues for a drug that is non-inferior. There are three points to be made;

1. There is significant interest in developing an alternative to the blockbuster Herceptin.
2. Wouldn't it be better to develop a drug to treat HER2 positive cancer patients that was superior to Herceptin.
3. From a patent perspective, rather than a biosimilar wouldn't a B-cell vaccine make more sense.