Court of Appeal dismisses Pfizer’s motion to strike PM(NOC) action as abusive
The Court of Appeal recently determined that the institution of proceedings under the “new” PM(NOC) Regulations, is not re-litigation or an abuse...Read More
Save It For The Action: Filgrastim Appeal Dismissed As Moot
In Amgen v Apotex, the Federal Court of Appeal dismissed Amgen’s appeal of the Federal Court decision that dismissed Amgen’s application for...Read More
Court dismisses first biologic prohibition application
Amgen brought this prohibition application to prevent the issuance of a Notice of Compliance to Apotex for its proposed filgrastim product. The...Read More
Would a biologic by any other (nonproprietary) name smell as sweet?
One of the many contentious issues in the evolving U.S. biosimilar regulatory landscape regards whether 351(k) biosimilar products will have the same...Read More
FDA approves Teva’s tbo-filgrastim for severe neutropenia
On August 29, 2012, the U.S. FDA approved Sicor Biotech’s BLA for tbo-filgrastim (XMO2 filgrastim), to reduce the time certain patient receiving...Read More
On your mark, get set, go! Biosimilar litigation takes off in Canada
On May 18, 2012, Amgen Canada Inc. and Amgen Inc. (“Amgen”) commenced a proceeding (Court File No. T-989-12) under the Patented Medicines...Read More