PrSandoz®Lenalidomide is approved for the same indications as the reference medicinePrRevlimid®.
PrSandoz® Lenalidomide will be distributed through RevAid®, the same program as the reference medicine to ensure a seamless transition for prescribers, patients and pharmacists.
This addition to the Sandoz Canada Gx Oncology portfolio can potentially allow millions of dollars in Canadian healthcare system savings.
Boucherville, September 1, 2021 – Sandoz Canada Inc. announced today the launch of Sandoz® Lenalidomide, making Sandoz Canada one of the first companies to offer a generic version of Revlimid® on the Canadian market. Sandoz® Lenalidomideis offered in blister pack of 21 or 28 capsules and is available in six strengths: 2.5 mg, 5 mg, 10 mg, 15 mg, 20 mg and 25 mg.
Sandoz® Lenalidomide is indicated for the treatment of patients with transfusion-dependent anemia due to Low- or Intermediate-1-risk myelodysplastic syndromes associated with a deletion 5q cytogenetic abnormality with or without additional cytogenetic abnormalities. Approval for this indication is based on red blood cell transfusion independence response rates. Also, Sandoz® Lenalidomide in combination with dexamethasone is indicated for the treatment of multiple myeloma patients who are not eligible for a stem cell transplant.
This product is already commercialized in 4 countries within the Sandoz Network and Canada will become the fifth country to commercialize it. Sandoz Canada generic version of Revlimid® will be distributed through RevAid®, the same distribution program as the reference medicine to ensure a seamless transition for healthcare providers and patients. As such, it will not require any additional educational material, certification or training. Healthcare professionals and patients will be able to count on Sandoz for educational tools, reimbursement and financial assistance where permitted.
“We are very proud to contribute to making life-enhancing medicines more accessible by launching affordable and effective generics like Sandoz® Lenalidomide, by supporting healthcare providers and patients, and by ensuring reliable supply,” says Michel Robidoux, President and General Manager of Sandoz Canada. “The millions of dollars in savings created by generics contribute to strengthening our healthcare system for all Canadians.”
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This press release contains forward-looking statements, including, but not limited to, potential future revenues from the sale of PrSandoz® Lenalidomide. 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 assurance that PrSandoz® Lenalidomide will be submitted or approved for other additional indications or labelling in other markets, or at any particular time, nor can it be guaranteed that PrSandoz® Lenalidomide be approved by a regulatory body or will be commercially successful in the future. In particular, management’s expectations regarding PrSandoz® Lenalidomide could be affected by a number of factors, including: uncertainties inherent in research and development, including unexpected clinical study results and additional analysis of existing clinical data; unexpected regulatory actions, delays or government regulations in general; the company’s ability to obtain or maintain intellectual property protection; general economic and industry conditions; the global trend towards streamlining healthcare costs, including constant pressure regarding pricing; impacts of the COVID-19 pandemic; unexpected manufacturing problems, and other risks and factors mentioned in form 20-F filed by Novartis AG with the US Securities and Exchange Commission. Sandoz is providing the information in this media 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 law.
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