Posted by Michael Wonder on 04 Apr 2017
Brenzys lists on the Australian PBS and Pfizer denied discovery of documents to establish grounds for patent infringement
4 April 2017 - As of 1 April 2017, Samsung Bioepis' Brenzys, a biosimilar to Pfizer's Enbrel (etanercept), will join the very short list of "a-flagged" biosimilars listed on the Australian Government's Pharmaceutical Benefits Scheme (PBS).
Pharmacists can substitute a prescribed biologic with an "a-flagged" biosimilar at the pharmacy level (ie. at dispensing).
The listing of Brenzys on the PBS coincided with the decision of the Federal Court of Australia to refuse an application by Pfizer for discovery before action of documents pertaining to the process of manufacture of Brenzys by Samsung Bioepis.
The launch and PBS listing of Brenzys, without an interlocutory injunction application from Pfizer, and the failed application for discovery shows that the pathway to restraining the launch of a biosimilar may be more difficult than in the small molecule market.
