Introducing NOROMBY & NOROMBY HP (Enoxaparin sodium solution)
Health Canada Approves Juno’s Enoxaparin Biosimilar
On October 14, 2020, Juno Pharmaceuticals Corp. (JPC) received a Notice of Compliance from Health Canada for Noromby and Noromby HP, biosimilar biologic drugs to Lovenox® and Lovenox HP® (the reference biologic drug). The approval is a significant milestone not only in JPC’s corporate development, marking the rapidly growing pharmaceutical company’s first entry into the local biosimilars market, but is of broader significance for Canadian healthcare as the first enoxaparin sodium biosimilar to be approved in Canada.
Authorization of a biosimilar means that it is highly similar to the reference biologic drug in terms of quality, efficacy and safety between the two products. Authorization of Noromby and Noromby HP was granted for all of the indications that are currently authorized for Lovenox and Lovenox HP.
The anticoagulant/antithrombotic agent has been approved for both intravenous administration and subcutaneous injection, and in multiple strengths, including 20 mg/0.2mL, 30 mg/0.3mL, 40 mg/0.4mL, 60 mg/0.6mL, 80 mg/0.8mL, 100 mg/mL, 120 mg/0.8mL and 150 mg/mL.
Enoxaparin sodium is commonly used in the treatment/prevention of both pulmonary embolism and deep vein thrombosis, conditions which account for approximately 65% of global consumption of LMWHs. Enoxaparin has also previously been used to treat patients suffering from acute coronary syndrome.
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