Sandoz receives positive CHMP opinion for breast and gastric cancer biosimilar trastuzumab

• Positive CHMP opinion based on comprehensive package of analytical, pre-clinical and clinical data

• Breast and gastric cancers are among most common types of cancer, accounting together for nearly half a million new cases every year in Europe alone^1,2

• Sandoz is committed to accelerating access to potentially life-changing treatments and continues to strengthen its oncology and supportive care portfolio

Basel, September 18, 2023 — Sandoz, a global leader in generic and biosimilar medicines, today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA), has adopted a positive opinion recommending marketing authorization for their biosimilar trastuzumab (150 mg, for intravenous use), developed by EirGenix, Inc.

The positive opinion for Sandoz trastuzumab, a monoclonal antibody, covers treatment of human epidermal growth factor receptor 2 positive (HER2-positive) breast cancer and metastatic gastric cancers, the same indications as approved by EMA for the reference biologic.¹

Sandoz and EirGenix signed a license agreement in April 2019. Under this agreement, EirGenix will remain responsible for the development and manufacturing of trastuzumab, while Sandoz will hold the rights to commercialize the medicine upon approval in respective markets.

Pierre Bourdage, Chief Commercial Officer, Sandoz, said: “Breast and gastric cancers are among the most frequently occurring in Europe and, combined, are responsible for nearly 200,000 deaths annually. Biosimilars have enormous potential to improve cancer care by substantially increasing access to these critical medicines.”

The impact of both breast and gastric cancers in Europe is significant. Each year, over 355,000 women are diagnosed with breast cancer and, with 92,000 deaths per year, it is the number one cause of cancer death among women.² Gastric cancer is the sixth most common of all cancer types and, with 107,000 deaths annually, it is the fourth most common cause of cancer-related death in Europe.³ In up to 20% of breast cancers⁴ and up to 30% of gastric cancers⁵ diagnosed, an HER2 protein overexpression (or HER2 gene amplification) is detected resulting in an uncontrollable growth and division of cells.^2,4 HER2 cancers are particularly aggressive cancer types that respond well to targeted treatment.^6,7

The comprehensive analytical, preclinical, and clinical data regulatory submission package included evidence derived from an extensive analytical characterization, in addition to results from a Phase I PK/PD study and a confirmatory Phase III study in breast cancer patients (EGC002). Both studies met their primary endpoints, confirming that the biosimilar matches the reference biologic in terms of pharmacokinetics as well as efficacy, safety and immunogenicity.

Sandoz is committed to helping millions of patients access critical and potentially life-changing biologic medicines sustainably and affordably across a range of areas including immunology, oncology, supportive care, and endocrinology. It has a leading global portfolio with eight marketed biosimilars and a further 25 assets in various stages of development. Since launching the first biosimilar in Europe in 2006, Sandoz has helped to create early and expanded patient access to life-altering medicines while increasing healthcare savings and creating competition that fuels further innovation.

Disclaimer 
This press release contains forward-looking statements within the meaning of the United States Private Securities Litigation Reform Act of 1995. Forward-looking statements can generally be identified by words such as “potential,” “can,” “will,” “plan,” “may,” “could,” “would,” “expect,” “anticipate,” “look forward,” “believe,” “committed,” “investigational,” “pipeline,” “launch,” or similar terms, or by express or implied discussions regarding potential marketing approvals, new indications or labeling for the investigational or approved products described in this press release, or regarding potential future revenues from such products. You should not place undue reliance on these statements. Such forward-looking statements are based on our current beliefs and expectations regarding future events, and are subject to significant known and unknown risks and uncertainties. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those set forth in the forward-looking statements. There can be no guarantee that the investigational or approved products described in this press release will be submitted or approved for sale or for any additional indications or labeling in any market, or at any particular time. Neither can there be any guarantee that, if approved, such generic or biosimilar products will be approved for all indications included in the reference product’s label. Nor can there be any guarantee that such products will be commercially successful in the future. In particular, our expectations regarding such products could be affected by, among other things, the uncertainties inherent in research and development, including clinical trial results and additional analysis of existing clinical data; regulatory actions or delays or government regulation generally; the particular prescribing preferences of physicians and patients; competition in general, including potential approval of additional generic or biosimilar versions of such products; global trends toward health care cost containment, including government, payor and general public pricing and reimbursement pressures and requirements for increased pricing transparency; litigation outcomes, including intellectual property disputes or other legal efforts to prevent or limit Sandoz from selling its products; general political, economic and business conditions, including the effects of and efforts to mitigate pandemic diseases such as COVID-19; safety, quality, data integrity or manufacturing issues; potential or actual data security and data privacy breaches, or disruptions of our information technology systems, and other risks and factors referred to in Novartis AG’s current Form 20-F on file with the US Securities and Exchange Commission. Novartis is providing the information in this press release as of this date and does not undertake any obligation to update any forward-looking statements contained in this press release as a result of new information, future events or otherwise.

References

1. European Medicines Agency (EMA). Herceptin EPAR. Available from https://www.ema.europa.eu/en/medicines/human/EPAR/herceptin. [Accessed August 2023]
2. European Commission. Breast Cancer Burden in EU-27 factsheet. Available from: https://ecis.jrc.ec.europa.eu/pdf/Breast_cancer_factsheet-Dec_2020.pdf. [Accessed August 2023]
3. Kamiya S, et al. Current trends in gastric cancer treatment in Europe. J Cancer Metastasis Treat. 2018:4:35.
4. BreastCancer.org. Understanding your pathology report: HER2 Status. Available from: https://www.breastcancer.org/pathology-report/her2-status. [Accessed August 2023]
5. BMC Cancer. Yang, T, et al. Prognostic and clinical significance of HER-2 low expression in early-stage gastric cancer. BMC Cancer. 2022;1168.
6. Mayo Clinic. HER2-positive breast cancer: What is it?. Available from: https://www.mayoclinic.org/breast-cancer/expert-answers/faq-20058066#:~:text=This%20protein%20promotes%20the%20growth,other%20types%20of%20breast%20cancer [Accessed August 2023].
7. Iqbal N & Iqbal N. Human Epidermal Growth Factor Receptor 2 (HER2) in Cancers: Overexpression and Therapeutic Implications. Mol Biol Int. 2014:852748.
   

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About Sandoz
Sandoz, a Novartis division, is a global leader in generic pharmaceuticals and biosimilars. Our purpose is to pioneer access for patients by developing and commercializing novel, affordable approaches that address unmet medical needs. Our ambition is to be the world’s leading and most valued generics company. Our broad portfolio of high-quality medicines covers all major therapeutic areas.

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CEO Richard Saynor on LinkedIn: https://www.linkedin.com/in/richard-saynor/

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