DLA Piper, Italy
Scientific Tracks Abstracts: J Bioanal Biomed
Biosimilars in Europe are typically branded differently from the reference drug, however the non-proprietary names of European biosimilars are identical to those of their reference drug. More specifically, biosimilars are named according to the degree of "similarity" if compared with the biologics. When the physico-chemical differences stay in the range defined by EMA, they take the same INN (International Nonproprietary Names) of biologics; when the range is exceeded, it is necessary to create a new INN. The situation is different in USA, where the FDA requires - for all biologic products ├ó┬?┬? that a randomlygenerated suffix is added to the INN in all cases. This presentation is aimed at addressing the consequences of the different policies in Europe and USA with regard to the branding of biosimilars on the industry, and on the development of the market.
Roberto Valenti is a partner at DLA Piper Italy. He focuses on IP litigation, including matters relating to trademarks, copyrights, designs, unfair competition and misleading and comparative advertising. He also has experience dealing with IP non-contentious matters, such as drafting licence and transfer agreements relating to trademarks, copyrights and designs, with a special focus in the life science sector. With a PhD in Intellectual Property, University of Pavia, in the last 7 years, he has been the Chairman of the Life Science Working Group of the American Chamber of Commerce in Italy. He is commended in the WTR 1000: The World's Leading Trademark Professionals 2017. Chambers Europe, Chambers Global, The Legal 500 EMEA and a number of client surveys have identified him as a leading individual in the IP field, with particular reference to the Life Science arena. He is listed as Acritas Star™ Lawyer 2017.
Journal of Bioanalysis & Biomedicine received 2511 citations as per Google Scholar report