Describing the Inevitable

About a decade ago, conventional wisdom held that mAbs are so complex that it would be extremely difficult, if not impossible, to develop biosimilar versions of them. While some mAb innovators may cling to this line of thinking, the writing on the wall says biosimilar mAbs are coming to the major markets, possibly as soon as 2013.

This is the conclusion stakeholders are drawing from EMA's draft guidelines laying out the non-clinical and clinical requirements for showing that a mAb-containing product is similar to another one already marketed...