Sandoz Canada launches its 6th biosimilar with Inclunox®

18 May 2021
www.globenewswire.com
Generic DrugBiosimilar
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: “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. Follow us on LinkedIn:  References For interview requests, please contact Paule Pelletier (see contact information below). Information:                     Paule PelletierSandoz Canada Inc.+1-514 702-7699paule.pelletier@sandoz.com / communications.canada@sandoz.com
Organizations
Indications
-
Targets
-
Drugs
Get started for free today!
Accelerate Strategic R&D decision making with Synapse, PatSnap’s AI-powered Connected Innovation Intelligence Platform Built for Life Sciences Professionals.
Start your data trial now!
Synapse data is also accessible to external entities via APIs or data packages. Leverages most recent intelligence information, enabling fullest potential.