Sandoz Canada launches its 6th biosimilar with Inclunox® and Inclunox® HP (Enoxaparin sodium solution for injection 100 mg/mL and 150 mg/mL (High Potency))

• Inclunox^® is an anticoagulant biosimilar¹ that has been approved by Health Canada for use in the six indications covered by the reference biologic medicine.
  
  

• New Sandoz biosimilar launch can potentially lower healthcare costs, especially for Canadian hospitals, as 75% of the distribution/administration of this drug in Canada is through hospital settings².
  
  

• Inclunox^® and Inclunox^® HP manufacturer is a recognized enoxaparin supplier worldwide and is already registered in more than 40 countries³. Canada will become the 20^th country to officially commercialize the product⁴.
  
  

• Internationally, this Sandoz biosimilar has been used to treat more than 95 millions patients days over the last year⁵.
  

BOUCHERVILLE, Quebec, May 17, 2021 (GLOBE NEWSWIRE) -- Sandoz Canada Inc. announced today the launch of ^PrInclunox^® and ^PrInclunox^® HP (enoxaparin sodium solution for injection, reference biologic drug: Sanofi’s ^PrLovenox^® and ^PrLovenox^® HP), which was authorized for sale in Canada by Health Canada on November 5, 2020. It 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. Inclunox^® is a solution for either intravenous administration or subcutaneous injection of enoxaparin sodium supplied in multiple pre-filled syringes formats options: 30 mg/0.3 mL, 40 mg/0.4 mL, 60 mg/0.6 mL, 80 mg/0.8 mL, 100 mg/1 mL, 120 mg/0.8 mL and 150 mg/1 mL.

Inclunox^® is indicated for:

• The prophylaxis of thromboembolic disorders (deep vein thrombosis) in patients undergoing: orthopedic surgery of the hip or knee; high-risk abdominal, gynecological, or urological surgeries; colorectal surgery. Also indicated in hospital or after hospital discharge for long-term prevention of venous thromboembolic diseases following hip replacement surgery.

• The prophylaxis of deep vein thrombosis (DVT) in medical patients who are at moderate risk of DVT and who are bedridden due to moderate to severe acute cardiac insufficiency (NYHA Class III or IV heart failure), acute respiratory failure revealing or complicating chronic respiratory insufficiency not requiring ventilatory support and acute respiratory infections (excluding septic shock), who require short-term prophylaxis of deep vein thrombosis.

• The prevention of thrombus formation in the extra-corporeal circulation during hemodialysis.

• The treatment of deep vein thrombosis, with or without pulmonary embolism.

• The treatment of unstable angina or non-Q-wave myocardial infarction, concurrently with ASA.

• The treatment of acute ST-segment Elevation Myocardial Infarction (STEMI), including patients to be managed medically or with subsequent Percutaneous Coronary Intervention (PCI).

“We are very excited to bring our enoxaparin biosimilars Inclunox^® and Inclunox^® HP to market by building on our worldwide experience with biosimilars. The enoxaparin biosimilar market represents more than 6 million syringes administered to patients every year across Canada”⁶ declared Michel Robidoux, President and General Manager of Sandoz Canada. “This launch is an important step as we pursue our ambition to become the leading biosimilars and generics company in Canada.”

Sandoz Canada has successfully completed the pan-Canadian Pharmaceutical Alliance (pCPA) negotiations for Inclunox^® and Inclunox^® HP, which is the first step in securing public reimbursement. The company is now actively working on securing reimbursement with both private and public players. In addition, INESSS recommended that Inclunox^® and Inclunox^® HP be listed on the List of Medications.

“As a division of Novartis, we pride ourselves as being one company delivering both innovation and sustainability to the healthcare system in Canada. Our biosimilars portfolio in Canada currently includes six biologic medicines covering the therapeutic areas of oncology, immunology and endocrinology, and we look forward to continuing to expand it as market exclusivity of more original biologics come to an end,” added Karine Matteau, Vice President, Bio-Generic Hospital/Physician channel and Head of Biosimilars at Sandoz Canada.

About Biosimilars

A biosimilar is a biologic medicine that has demonstrated it is highly similar and has no clinically meaningful differences in efficacy and safety compared to the reference biologic⁷ already authorized for sale. Biosimilars may become commercially available following the expiry of patents and data protection periods of the reference biologic medicine.

The Patented Medicines Pricing Review Board has estimated that private and public drug plans across Canada could save from CA$294 million to CA$1.136 billion by 2021 for established biosimilars available in Canada for at least two years across a portfolio of products and from CA$222 million to CA$447 million by 2023 for new biosimilars that recently entered the Canadian market.⁸ The broader use of biosimilar medicines, including the implementation of biosimilar switching policies, can also help public and private drug plans improve their sustainability by adding new medicine listings and expanding existing medication coverage for patients.

For further information on biosimilars in Canada, visit BiosimilarsGeneration.ca.

^® Trademark owned by the registered owner.

Disclaimer

The foregoing release contains forward-looking statements that can be identified by terminology such as “potential,” “can,” “soon,” “planned” or similar expressions, or by express or implied statements regarding potential marketing or new labelling approvals for Inclunox^® or other potential products in the Sandoz pipeline of biosimilars, or regarding potential future revenues from the sale of Inclunox^® or other marketed products from the Sandoz biosimilars portfolio or potential future revenues from the Sandoz portfolio of biosimilars in development. You should not place undue reliance on these statements. These forward-looking statements reflect management’s current beliefs and expectations regarding future events and involve known and unknown risks and significant uncertainties. Should one or more of these risks or uncertainties materialize, or should any of the underlying assumptions prove incorrect, actual results could differ materially from those set forth in the forward-looking statements. There can be no guarantee that Inclunox^® or any other marketed product from the Sandoz portfolio of biosimilars will be submitted or approved for sale in other markets, or at any particular time. There can also be no guarantee that potential products from the Sandoz portfolio of biosimilars under development will be submitted or approved for sale in other markets, or at any particular time. There can also be no guarantee that, if approved, potential products in the Sandoz portfolio of biosimilars in development will be approved for all indications listed on the label of the reference product. There can also be no guarantee that Inclunox^®, other marketed products in the Sandoz portfolio of biosimilars or other potential products in the Sandoz portfolio of biosimilars in development will be commercially successful in the future. In particular, management’s expectations regarding Inclunox^® and other biosimilar candidates and marketed products could be affected by, among other things, regulatory actions, delays or government regulation generally; uncertainties inherent in research and development, including the results of clinical studies and further analysis of existing clinical data; competition in general, including potential approval of new versions of Inclunox^®; the global trend toward rationalizing healthcare costs, including pricing pressures and reimbursement issues from healthcare payers, the general public and governments; the outcome of litigation, including intellectual property litigation and other legal actions to prevent or restrict the sale of Sandoz biosimilar products; physicians’ and patients’ particular prescription preferences; general economic and industry conditions; impacts of the COVID-19 pandemic; manufacturing, safety or quality issues; and other risks and factors referred to in Novartis AG’s Form 20-F on file with the US Securities and Exchange Commission. Sandoz is providing the information in this press release as of today and does not undertake any obligation to update any forward-looking statements described herein as a result of new information, future events or otherwise, except as required by the law.

About Sandoz

Sandoz International GmbH is a world leader in generics and biosimilars and a division of the Swiss multinational Novartis AG. A true leader in its field, Sandoz Canada markets and distributes a wide range of generics and biosimilars.

Sandoz Canada is a pioneer, a leader and trusted supplier of quality biosimilars based on the global experience and capabilities of Sandoz GmbH in the development, manufacturing and commercialization of biosimilars since 1996. Sandoz launched the first biosimilar in Europe in 2006 and in the Canadian market in 2009.

www.sandoz.ca

Follow us on LinkedIn: https://www.linkedin.com/company/sandoz-canada/

References

1. Government of Canada, Policy Statement: Clarifying the appropriate regulatory pathway for subsequent entry low molecular weight heparins,
   https://www.canada.ca/en/health-canada/services/drugs-health-products/biologics-radiopharmaceuticals-genetic-therapies/applications-submissions/guidance-documents/policy-statement-clarifying-appropriate-regulatory-molecular-weight-heparins.html

   • Based on the nature of the molecule, Health Canada decided, back in 2013, that the subsequent entry enoxaparin should be categorized as a biosimilar.

2. IQVIA (CDH), Marketing Database including data from the last 12 months, March 2021.

3. Rovi, Enoxaparin sodium rovi, [manufacturer report].

4. Ibid.

5. Rovi, 4th periodic safety update report for active substance(s): enoxaparin sodium atc code(s): b01ab05, [manufacturer report]

6. Ibid #2.

7. Health Canada Biosimilars Fact Sheet: Biosimilars Explained. https://www.canada.ca/en/health-canada/services/drugs-health-products/biologics-radiopharmaceuticals-genetic-therapies/applications-submissions/guidance-documents/fact-sheet-biosimilars.html

8. Potential savings associated with biosimilars in Canada: Government of Canada. https://www.canada.ca/en/patented-medicine-prices-review/services/reports-studies/biologics-part2-biosimilar-savings2018.html
   

For interview requests, please contact Paule Pelletier (see contact information below).

Information:
Paule Pelletier
Sandoz Canada Inc.
+1-514 702-7699
paule.pelletier@sandoz.com / communications.canada@sandoz.com