Having unsuccessfully asserted a patent under the previous legal framework in Canada does not preclude an originator from trying again following legislative amendments enacted in 2017, the country’s Federal Court of Appeal has ruled in a decision on Pfizer’s Nivestym filgrastim biosimilar.

Originators that make discounts on biologic list prices conditional on hospitals not switching treatment to anti-TNF biosimilars may be breaching competition law, the Netherlands’ competition authority is warning.

In this podcast discussion, Generics Bulletin’s David Wallace talks to Informa Pharma Consulting’s Duncan Emerton about Celltrion’s CHMP nod for subcutaneous Remsima, the product’s imminent approval and launch, and what it means for the future of biosimilars.

A KPMG report commissioned by Medicines for Europe finds that nine ‘key ingredients’ could maximize savings for generic and biosimilar medicines in European hospitals.

A lower-than-expected number of fee-paying application submissions in FY 2018 resulted in the agency spending approximately $9.7m more than anticipated from its user fee carryover balance, leading to a reset of spend-down targets for the remainder of BsUFA II.

Belgium’s competition regulator has announced that it is investigating practices that have restricted or prevented biosimilars from entering the market.