Sandoz GmbH

CIMERLI®*, a ranibizumab biosimilar, is interchangeable with LUCENTIS®** (ranibizumab injection) for all approved indications Dedicated retina sales and field reimbursement team integrated into Sandoz, ensuring seamless experience for providers and patients March 4, 2024 – Sandoz, the global leader in generic and biosimilar medicines, has completed the acquisition of the US biosimilar CIMERLI®* (ranibizumab-eqrn) from Coherus BioSciences, Inc, ahead of anticipated timelines. The acquisition builds on the leading Sandoz ophthalmic platform in the US and lays an even stronger foundation for future product launches. Keren Haruvi, President Sandoz North America said: “Today we further expand the Sandoz biosimilar portfolio, while advancing our mission in the US of pioneering patient access to more affordable and much-needed medicines. With the addition of CIMERLI® to our existing ophthalmology franchise, we can now offer even more treatment options for US patients with vision impairment and loss.” CIMERLI® is indicated for the treatment of certain retinal diseases that, if left untreated, can cause vision loss, which ranks among the top 10 causes of disability in the United States.1 It is an anti-VEGF therapy within a class of biologics that helps retinal patients maintain or gain vision.2 Sandoz and Coherus entered into an agreement in January 2024 through which Sandoz agreed to acquire the full CIMERLI® business for an upfront cash purchase price of USD 170 million. The transaction includes a biologics license application, product inventory, ophthalmology sales and field reimbursement talent, as well as access to proprietary commercial software. CIMERLI®* solution for injection (6 mg/mL and 10 mg/mL) is an FDA-approved biosimilar to reference product LUCENTIS®** (ranibizumab injection) indicated for the treatment of multiple retinal diseases, including neovascular (wet) age-related macular degeneration (AMD), macular edema following retinal vein occlusion (RVO), diabetic macular edema (DME), diabetic retinopathy (DR) and myopic choroidal neovascularization (mCNV).3 CIMERLI®* is an anti-VEGF therapy within a class of biologics that helps retinal patients maintain or gain vision.2 CIMERLI®* was approved by the FDA in August 2022, having met FDA’s rigorous standards of biosimilarity to the reference product, including safety, efficacy and quality. Launched in October 2022, it is the first and only FDA-approved biosimilar interchangeable with LUCENTIS®** for all indications. References Centers for Disease Control and Preventon. Vision Loss: A Public Health Problem. December 19, 2022. Accessed February 22, 2024. Vision Loss: A Public Health Problem | CDC American Academy of Ophthalmology. Anti-VEGF Treatments. July 26, 2023. Accessed February 22, 2024. Anti-VEGF Treatments - American Academy of Ophthalmology (aao.org). Sandoz (SIX: SDZ; OTCQX: SDZNY) is the global leader in generic and biosimilar medicines, with a growth strategy driven by its Purpose: pioneering access for patients. 22,000 people of more than 100 nationalities work together to bring Sandoz medicines to some 500 million patients worldwide, generating substantial global healthcare savings and an even larger total social impact. Its leading portfolio of more than 1,500 products addresses diseases from the common cold to cancer. Headquartered in Basel, Switzerland, Sandoz traces its heritage back to the year 1886. Its history of breakthroughs includes Calcium Sandoz in 1929, the world’s first oral penicillin in 1951, and the first biosimilar in 2006. In 2022, Sandoz achieved sales of USD 9.1 billion and core EBITDA of USD 1.9 billion. The content above comes from the network. if any infringement, please contact us to modify.

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