Sandoz receives Health Canada approval for Jubbonti®, first and only denosumab biosimilar for treatment of osteoporosis

• Biosimilar Jubbonti^® approved for all indications of Prolia* reference medicine.
• Sandoz continues to expand access for patients in Canada, offering denosumab biosimilar to treat osteoporosis and increase bone mass.
• Health Canada approval based on robust Phase I and Phase III clinical studies.        
• Results confirm that Jubbonti^® provides same risks and benefits in terms of efficacy, safety and immunogenicity as reference medicine.

BOUCHERVILLE, Quebec, Feb. 20, 2024 (GLOBE NEWSWIRE) -- Sandoz Canada is pleased to announce that Health Canada has provided authorization to market Jubbonti^® (denosumab subcutaneous injection, reference medicine: Prolia^*).

Jubbonti^® is the first and only Health Canada-approved denosumab biosimilar for osteoporosis and increasing bone mass. This human monoclonal antibody and RANK ligand inhibitor (bone metabolism regulator) is approved to treat all five indications covered by the reference medicine and is available as a 60 mg/mL solution in single-use prefilled syringe. Jubbonti^® should be available on the Canadian market in the coming months.  

“Denosumab is an important biologic therapy used by more than 500,000 patients in Canada.⁽¹⁾ As a pioneer in patient access, we take great pride in being the first company to introduce and bring to the Canadian market a denosumab biosimilar in the field of immunology.” - Michel Robidoux, President and General Manager,  Sandoz Canada

“In light of the recent Health Canada approval of the denosumab biosimilar Jubbonti^®, I am enthusiastic that more Canadian patients suffering from osteoporosis will benefit from this class of medication. Biosimilars such as Jubbonti^® not only expand access to efficacious and safe medicines but should help decrease healthcare system costs.” - Dr. Jean-Pierre Raynauld, MD, FRCPC, Rheumatologist

Jubbonti^® is Sandoz Canada’s seventh biosimilar, demonstrating the company’s ongoing commitment to grow its portfolio to respond to patient needs. Sandoz Canada remains committed to delivering affordable and high-quality medicines, with a plan to introduce 24 new biosimilars.

About Biosimilars
A biosimilar biologic medicine, or biosimilar, is a biologic medicine that is shown to be highly similar and has no clinically meaningful differences in efficacy and safety in comparison to an original-brand (“reference”) biologic already authorized for sale. Biosimilars may become commercially available following the expiry of patents and data protection periods of the reference biologic medicine.

Sandoz launched the first biosimilar in Europe, in 2006, and in the Canadian market, in 2009. Since 2009, Health Canada has approved 55 biosimilars of reference biologics present on the Canadian market⁽²⁾.

Biosimilars have the potential to improve access to effective treatments while reducing the current economic burden on the Canadian healthcare system, patients, physicians, and taxpayers as a whole. The Patented Medicines Pricing Review Board has estimated that biosimilars of four high-selling biologics saved Canadians an estimated $990 million over three years.⁽³⁾ The broader use of biosimilar medicines, including the implementation of biosimilar transition policies, can also help public and private drug plans improve their sustainability by adding new medicine listings and expanding existing medical coverage for patients.

Disclaimer
This Media Release contains forward-looking statements, which offers no guarantee with regards to future performance. These statements are made based on management’s views and assumptions regarding future events and business performance at the time the statements are made. They are subject to risks and uncertainties including, but not confined to, future global economic conditions, exchange rates, legal provisions, market conditions, activities by competitors and other factors outside of the control of Sandoz. Should one or more of these risks or uncertainties materialize or should underlying assumptions prove incorrect, actual outcomes may vary materially from those forecasted or expected. Each forward-looking statement speaks only as of the date of the statement, and Sandoz undertakes no obligation to publicly update or revise any forward-looking statements, except as required by law.

About Sandoz Canada
As a Canadian leader in off-patent medicines, Sandoz Canada has a product portfolio that includes over 700 generics and biosimilars spanning multiple therapeutic areas, such as anti-infective, cardiovascular, central nervous system, immunology and oncology. In 2022, Sandoz products helped over 8 million patients in Canada (source: IQVIA). With its 300 employees across the country and headquarters based in Boucherville (QC), Sandoz Canada is a trusted partner for pharmacists, physicians and hospitals for quality medicine, outstanding customer service and is committed to ensuring a reliable supply. For more information about Sandoz Canada, visit: www.sandoz.ca

About Sandoz AG
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 social impact. Its leading portfolio of more than 1,500 products addresses diseases from common colds 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 world’s first biosimilar in 2006. In 2022, Sandoz sales achieved USD 9.1 billion and core EBITDA of USD 1.9 billion.

Two photos accompanying this announcement are available at
https://www.globenewswire.com/NewsRoom/AttachmentNg/47f59a1e-3899-4bee-bf42-b6d1680a27a4
https://www.globenewswire.com/NewsRoom/AttachmentNg/dbe8aedb-dae7-4444-93b7-5eed7e66167d

_{® is a registered trademark used under license by Sandoz Canada.
*is a trademark owned by its respective registrant.}
⁽¹⁾ _{Data on file, Sandoz Canada.}
⁽²⁾ _{Health Canada Drug Product Database (Consulted on February 12, 2024)}
⁽³⁾ _{Source: Zhang, Yvonne. “Biosimilars in Canada: Policies to Promote Switching and What It Means for Payers.” Patented Medicine Prices Review Board, p. 11. biosimilars-policies-promote-switching.pdf (canada.ca) (Consulted on January 9, 2024).}