IP key to US biosimilars success – report

Strong IP knowledge is one of four key factors to succeeding in the burgeoning US biosimilars market, according to an industry report.

Biosimilars are biological medical products in which the active drug substance is made by or derived from a living organism.

Thomson Reuters IP & Science found that early entrants in the US market will have a “strong understanding of relevant intellectual property”.

The report noted, however, that challenging non-abbreviated biologic license application (BLA) patents is yet to be fully tested.

“Without an understanding of the realities of the process, uncertainty still surrounds the topic within the industry. The patent exchange process has been scrutinised due to the requirements for biosimilar applicants to share sensitive information with competitors.”

BLA patent owners can refer to previous challenges under the new drug application (NDA) route, the report said, despite there being “many differences” between them. The report showed that, as of December 2012, Teva has challenged the most NDA patents (169), followed by Actavis (132) and Mylan (131).

“Intellectual property experience isn’t limited to understanding the patent landscape of a specific reference product or patent litigation. Owning patents associated with a biologic product, such as a process patent, can be a strong indicator of which companies have strong IP capabilities, but also which companies are future competitors in the biosimilar market,” the report said.

The three other important pre-requisites for market success are access to biologic manufacturing capabilities, experience with running clinical trials and experience in regulated markets, according to the report.

It concluded that Sandoz, Teva and Hospira will succeed in the US biosimilars market, while the Amgen-Actavis alliance, Samsung Bioepis/Merck, Pfizer and Boehringer Ingelheim are expected to provide tough competition.