US federal judge declined Amgen’s request to block sales of Novartis’ Zarzio
Zarzio is a Neupogen (filgrastim, Amgen) biosimilar used to prevent infections in patients on chemotherapy. Amgen attempted to delay the launch of its competitor based on Novartis’ failure to meet a regulatory requirement of mandatory inspection of generics manufacturing processes for non-violation of patents still in place (a.k.a., patent dance). Amgen plans to file an appeal in a higher court, but the current ruling as well as the US Food and Drug Administration’s (FDA) prior product approval reflect the overall agreement of both judiciary and regulatory authorities to open the door to the US market for biosimilars. Zarzio was approved as a biosimilar in the USA on March 6 this year for all indications as the original biologic, but it is not interchangeable, and it cannot be dispensed by a pharmacy instead of Neupogen without physician’s approval. FDA appended an -sndz placeholder to the INN name in order to differentiate between products. FDA and legislative authorities will decide on both registration and naming procedures for biosimilars in the near future. This year’s events in the USA, however, may be of importance on a global scale. Legislative and regulatory decisions in the US pharmaceutical market, as prior experience has shown, may influence decision-making in other countries.
Sources: Wall Street Journal, Forbes, Generics and Biosimilars Initiative