Considering all the Factors

Recent developments in the EU have shed some light on two important factors in the economics of biosimilars - how abbreviated a clinical path they can follow, and whether they will be regarded as interchangeable with the original molecule. Both factors will be determined in part by whether there is immunogenicity when patients are switched from the originator to the follow-on product.

On the one hand, experience with biologics such as insulin and somatropin (hGH) demonstrates that in the absence of therapeutic interchangeability, the existence of multiple competing products may not result in major pricing competition. ...