On 9 January 2026, Aurobindo Pharma announced in a regulatory filing that its subsidiary, CuraTeQ Biologics, has received approval from Health Canada for Dyrupeg®, biosimilar to Amgen’s Neulasta® (pegfilgrastim). In the same regulatory filing, CuraTeq also disclosed that it has three other biosimilar applications currently under review with Health Canada.
Dyrupeg® was approved in the EU in March 2025 following its positive recommendation from the EMA’s CHMP two months earlier. In June 2025, Dyrupeg® also received marketing authorisation in the UK.
There are a number of other pegfilgrastim biosimilars approved in Canada, including Apotex’s Lapegla® (June 2018). Mylan/Biocon’s Fulphila® (June 2018), Accord Healthcare’s Pelgraz® (September 2018), and Nora Pharma’s Niopeg® (April 2024).