Apotex Bags First Biosimilar Neulasta, Plans To Undercut Amgen In Canada By 25%

Apotex is hoping to sell its biosimilar version of Amgen’s Neulasta at a 25% discount in Canada after gaining approval there in what seems to be a world first. Might the Canadian OK help unblock the path to approval in the US and the EU?

Approved
Apotex has received approval in Canada for its biosimilar pegfilgrastim

Apotex Inc. appears to be ahead in the global race to market a biosimilar version of Amgen Inc.’s blockbuster G-CSF product, Neulasta (pegfilgrastim). The company received approval in its native Canada for its version, Lapelga, last month and is now awaiting a decision on its request for a reimbursement listing at a 25% discount to the originator drug. 

It is being suggested that the Canadian approval might herald a regulatory green light for biosimilar pegfilgrastims in

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