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Approval Alert: Health Canada Approves Nora Pharma’s Niopeg® (peg-filgrastim)

Apr 19, 2024

On 19 April 2024, Nora Pharma (subsidiary of Sunshine Biopharma) announced its entry into the biosimilars market with Health Canada’s approval of Niopeg® (peg-filgrastim), a biosimilar product comparable to Amgen’s NEULASTA®.

This follows Coherus’ launch of Udenyca Onbody® another biosimilar to Amgen’s NEULASTA® on 21 February 2024.

Peg-filgrastim was one of the first approved biosimilar molecules, and it is interesting to see new biosimilars approved 22 years after the first US approval in 2002.