How quick was that, page-7

For those interested in the biosimilar debate the article in Bloomberg titled Amgen Moves Closer to Selling Competitor for AbbVie's Humira, posted July 13, 2016, will be of interest. As Max Nisen makes the point in With Biosimilars, Big Pharma Fights Itself, posted July 13, 2016, big companies aren't just fighting biosimilar versions of their drugs - they're making them. Nisen is making the point that Pharma can't have it both ways: develop biosimilar drugs for approval and marketing and at the same time defend against biosimilar versions of their own drugs.

What I am more interested in however, is the debate about extrapolation: approving a biosimilar drug to treat all diseases covered by the original drug - without the necessity to run separate clinical trials. The argument turns upon the safety, efficacy, purity and potency of biosimilars compared to the original. For instance, what are the implications of extrapolation for Her-Vaxx and B-cell vaccine mimotopes?