Introducing Jubbonti® and Wyost®, the first denosumab biosimilars on the Canadian market

— Jubbonti® and Wyost® are first denosumab biosimilars available in Canada, reflecting the Sandoz Purpose of pioneering access for patients

— Jubbonti® and Wyost® approved for all indications of respective reference medicines

— Sandoz Canada has a leading biosimilars portfolio, with many more in the pipeline

BOUCHERVILLE, Quebec, Aug. 12, 2024 (GLOBE NEWSWIRE) -- Sandoz Canada, a leader in generics and biosimilars, today announces the launch of two denosumab biosimilars: Jubbonti® and Wyost®.

Jubbonti® is available in 60 mg/mL solution in single-use prefilled syringe and is approved for treating osteoporosis and increasing bone mass. The product is expected to be listed on all provincial formularies in the near future.

Wyost® is available in 120 mg/1.7 mL solution for subcutaneous injection and is approved for the prevention of bone fractures in bone metastatic cancers and the treatment of bone giant cells tumors in adults. Both internal and external packaging include GS1 standard barcoding for easy identification.

Jubbonti® is approved for all indications of its reference medicine Prolia® while Wyost® is approved for all indications of its reference medicine Xgeva®.*

Michel Robidoux, President and General Manager, Sandoz Canada

“It is great news that Canadians will now have access to high-quality denosumab biosimilars. This launch reflects our deep commitment to our Purpose of pioneering access for patients, as Sandoz Canada is the first and only company to offer these biosimilars in the country.”

Patients and healthcare professionals will be able to benefit from the Sandoz Plus Patient Support Program services during their treatment with Wyost® or Jubbonti®.

Sandoz is dedicated to responding to the evolving needs of healthcare professionals and patients. Sandoz Canada’s biosimilars portfolio covers the areas of oncology, dermatology, gastroenterology, immunology and endocrinology.

* Xgeva® and Prolia® are registered trademarks of Amgen Inc.

Learn more

• February 20, 2024: Sandoz receives Health Canada approval for Jubbonti^®, first and only denosumab biosimilar for treatment of osteoporosis
• March 4, 2024: Sandoz obtains Health Canada authorization to market Wyost^®, first and only denosumab biosimilar for oncology indications

About Biosimilars
A biosimilar is a successor to a biological medicine (known as the “reference medicine”) for which the patent has expired and exclusivity has been lost. Biosimilars have demonstrated to have similar safety and efficacy as their reference medicines.

Sandoz launched the first biosimilar in Europe in 2006 and in the Canadian market in 2009. Since 2009, Health Canada has approved 59 biosimilars of reference medicines present on the Canadian market (1).

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 CAD 990 million over three years (2). 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.

(1) Health Canada Drug Product Database (Consulted July 18, 2024)
(2) 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).

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. More than 20,000 people of more than 100 nationalities work together to ensure 800 million patient treatments are provided annually by Sandoz, generating substantial global healthcare savings and an even larger social impact. Its leading portfolio of approximately 1,500 products addresses diseases from the common cold to cancer. Headquartered in Basel, Switzerland, Sandoz traces its heritage back to 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 2023, Sandoz recorded sales of USD 9.6 billion.

A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/1389ce09-477d-4da8-b87a-03404d01fde6