Thursday, July 1, 2010

New biosimlars report looks at commercial aspect

Industry Standard News has a new report titled, "The Prescribing Outlook for Biosimilars." In creating this report, researchers talked to physicians about safety, efficacy, pricing and other critical characteristics when it came to prescribing these drugs.

According to Kevin Olson, President, ISR,
“Because there is no regulatory pathway for approval of these products in the United States, the body of writing on this topic focuses either on the development of biosimilars or on the implications for approval of the products after development. We believe that drug developers and their partners in commercial divisions should also understand what adoption of these products may look like as it may have implications for development strategy and will certainly impact a product’s commercialization strategy. For example, we found that over half of the respondents believe that regulatory authorities should require full-fledged clinical trials for biosimilars as a condition of approval. This was true among both U.S. prescribers and E.U. prescribers and is an indication of prescribers’ levels of comfort with the products.”

Read the full article and find out more about the report here.

IIR’s 2nd Annual Business of Biosimilars conference delivers effective strategies to navigate scientific, regulatory, economic, and legal challenges you face to remain competitive in commercializing your biosimilar portfolio in the United States and abroad.


Share this article with your social network, just click below to share now!


No comments :

Post a Comment