Sandoz launches oncology generic gefitinib in 13 EU countries at loss of market exclusivity, expanding access to essential medicine
Jul 02, 2019
Sandoz gefitinib indicated for adult patients with locally advanced or metastatic non-small cell lung cancer with activating mutations of EGFR-TK
More than 300,000 European men and women are diagnosed with lung cancer annually, making it the fourth most common cancer
With launch Sandoz builds on robust 50+ medicine oncology portfolio globally, including chemotherapy, targeted therapy, hormones and supportive care
Holzkirchen, Germany, July 2, 2019- Sandoz today announced the launch of the generic oncology medicine gefitinib indicated for adult patients with locally advanced or metastatic non-small cell lung cancer with activating mutations of EGFR-TK, which is recommended by ESMO as first-line treatment. The medicine will become available immediately in 13 countries across Europe on the day the reference medicine loses market exclusivity. Sandoz will continue to expand to other countries through a phased rollout.
"Generics help expand access to medicine, sometimes as much as doubling the amount of patients treated without any increase in cost," said Francesco Balestrieri, ad interim CEO, Sandoz. "At Sandoz, we recognize that oncology still lags behind seven other therapeutic areas that already benefit from considerable generic competition. The day one launch of generic gefitinib, seen by oncology experts as an essential treatment, is part of a wider Sandoz effort to change that equation."
In Europe lung cancer is the fourth most common cancer in both women and men, only exceeded by breast, prostate and colorectal cancer. Each year approximately 312,000 patients are diagnosed with lung cancer. Non-small-cell lung carcinoma (NSCLC) is any type of epithelial lung cancer other than small cell lung carcinoma (SCLC) and accounts for approximately 80% to 85% of all lung cancers cases.
Sandoz is the #1 provider of generic oncology medicines worldwide with a broad portfolio of more than 50 products, ranging from chemotherapy, hormones and supportive care to biologics. Its growing oncology portfolio covers an industry-leading 75% of molecules on the WHO's global Oncology Essential Medicines List,. It invests in research and development to improve the lives of cancer patients and liberate healthcare resources through increased access to high-quality, affordable medicines.
About Gefitinib Gefitinib is a once-daily, oral, non-chemotherapy medicine indicated for monotherapy treatment of adult patients with locally advanced or metastatic NSCLC with activating mutations of EGFR-TK. It has been shown to potently inhibit EGFR, a protein involved in the growth and development of this type of cancer. The ESMO guidelines recommend gefitinib as a first-line treatment option for patients with EGFR-activating mutation metastatic NSCLC. Gefitinib is part of the national essential medicines list for cancer. European regulatory approval was received for the generic molecule in July 2018, but generic products can only be made available at loss of market exclusivity of the reference product, provided that the patent protection has already expired.
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About Sandoz Sandoz, a Novartis division, is a global leader in generic pharmaceuticals and biosimilars and a pioneer in the emerging field of prescription digital therapeutics. Our purpose is to pioneer access to healthcare by developing and commercializing novel, affordable approaches that address unmet medical need. Our broad portfolio of high-quality medicines, covering all major therapeutic areas and increasingly focused on value-adding differentiated medicines, accounted for 2018 sales of USD 9.9 billion. Sandoz is headquartered in Holzkirchen, in Germany's Greater Munich area.