On 23 August 2024, Indian-based Lupin announced that its Armlupeg®, biosimilar to Amgen’s Neulasta® (pegfilgrastim) received approval from Health Canada. Armlupeg® is available in a pre-filled syringe of 6mg/0.6 ml.
This approval comes over 6 years after the first pegfilgrastim biosimilar was approved in Canada in June 2018 (Apotex’s Lapelga®). Shortly after, Mylan/Biocon’s Fulphila® (pegfilgrastim) was approved in the US (June 2018) and Accord Healthcare’s Pelgraz (pegfilgrastim) was approved in the EU (September 2018).
More recently, in February 2024, Coherus announced its US launch of Udenyca OnBody®, an on-body injector presentation of Undeyca® (pegfilgrastim-cbqv).