Sandoz Launches Sixth Biosimilar in Canada

Sandoz Canada launched its sixth biosimilar, Inclunox (enoxaparin sodium), on the Canadian market, according to a company statement.

Inclunox is a biosimilar for Lovenox, a blood thinning medication used to treat and prevent deep vein thrombosis (DVT) and pulmonary embolism during pregnancy and following certain surgeries. Inclunox was approved for marketing by Health Canada in November 2020.

“The enoxaparin biosimilar market represents more than 6 million syringes administered to patients every year across Canada,” said Michel Robidoux, president and general manager of Sandoz Canada.

In Canada, Inclunox was approved for the following indications:

• A prophylaxis of thromboembolic disorders in patients undergoing orthopedic hip or knee surgery, high-risk surgeries for abdominal, gynecological, or urological reasons, and colorectal surgery
• A prophylaxis in bedridden patients who are at a moderate risk of developing deep vein thrombosis
• Prevention of thrombus formation in the extra-corporeal circulation during hemodialysis
• Treatment of deep vein thrombosis, with or without a pulmonary embolism
• Treatment of unstable angina or non-Q-wave myocardial infarction
• Treatment of acute ST-segment elevation myocardial infarction

In addition to the launch, Sandoz Canada took the first step to securing public reimbursement for Inclunox and Inclunox HP, its high potency formulation, by completing negotiations with the pan-Canadian Pharmaceutical Alliance.

“[Sandoz Canada] is one of the first companies to make available a biosimilar version of enoxaparin sodium solution for injection, thus contributing to potentially help lower healthcare costs for Canadian hospitals and private and public payers,” said the company.

According to the Generics and Biosimilars Initiative, the biosimilar was approved alongside Noromby, another enoxaparin sodium biosimilar developed by Juno Pharmaceuticals, making them the first enoxaparin sodium biosimilars to receive regulatory approval in Canada.

Previously, there had been debate regarding whether non-originator low molecular weight heparins, like enoxaparin sodium, should be classified as generics or biosimilars.

In 2013, Health Canada clarified its regulatory pathway, deciding that these products qualified for approval under the pathway created for “subsequent entry biologics,” essentially classifying them as biosimilars.

The launch comes just a few months after Sandoz Canada launched its adalimumab biosimilar (Hyrimoz) in February 2021.

In addition to Inclunox and Hyrimoz, Sandoz Canada has marketed a pegfilgrastim biosimilar (Ziextenzo); a rituximab biosimilar (Riximyo); a somatropin biosimilar (Omnitrope); and an etanercept biosimilar (Erelzi). The company has also begun enrollment for a phase 3 clinical trial for an aflibercept biosimilar candidate.

Several Canadian provinces have implemented biosimilar initiatives, including newcomers Québec and New Brunswick, which call for new starts and current users of certain reference biologics to automatically be switched to biosimilar versions.

Although none of the current biosimilar programs require switches to biosimilar enoxaparin sodium, the participating provinces periodically update their lists to include more biologics, suggesting that enoxaparin sodium could be added to lists in the future.