The latest news about Samsung Bioepis
12:00 ON JUNE 26, 2020 CET
• AYBINTIO®, a biosimilar candidate referencing Avastin®i (bevacizumab), is Samsung Bioepis’ second oncology biosimilar to be recommended for marketing authorization by the European Medicines Agency
• AYBINTIO® is recommended for the treatment of the same types of cancer as reference bevacizumab
INCHEON, Korea – Jun 26, 2020 – Samsung Bioepis Co., Ltd. today announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion for AYBINTIO®, a biosimilar candidate referencing Avastin® (bevacizumab). AYBINTIO® has been recommended for approval for the treatment of the same types of cancer as reference bevacizumab in the European Union (EU)ii iii, including metastatic carcinoma of the colon or rectum (mCRC), metastatic breast cancer (mBC), non-small cell lung cancer (NSCLC), advanced and/or metastatic renal cell cancer (mRCC), epithelial ovarian, fallopian tube and primary peritoneal cancer and cervical cancer. The CHMP’s positive opinion will now be reviewed by the European Commission (EC) to decide on granting marketing authorization for AYBINTIO®.
“We are delighted by our progress in expanding patient access to high-quality biopharmaceuticals,” said Hee Kyung Kim, Senior Vice President, Clinical Science and Regulatory Affairs at Samsung Bioepis. “Once approved, AYBINTIO will be a valuable treatment option for different types of cancers, potentially helping many patients across Europe.”
The Marketing Authorization Application (MAA) for AYBINTIO® was supported by a comprehensive data package and totality of evidence which included analytical, pharmacokinetic (PK) and clinical data, as well as pharmacology and toxicology data. These data demonstrated that AYBINTIO® and reference bevacizumab are highly similar with no clinically meaningful differences. Further, the company submitted a Biologics License Application (BLA) for AYBINTIO® in September 2019 and is currently under review by the U.S. Food and Drug Administration (FDA)
i Avastin® is a registered trademark of Genentech Inc.
ii European Medicines Agency. Avastin Summary of Product Characteristics. Available at https://www.ema.europa.eu/en/documents/product-information/avastin-epar-product-information_en.pdf [Accessed May 2020]
iii AYBINTIO® is recommended for the treatment of certain types of cancer, including in combination with fluoropyrimidine-based chemotherapy for metastatic carcinoma of the colon or rectum; in combination with paclitaxel for metastatic breast cancer; in combination with platinum-based chemotherapy for unresectable advanced, metastatic or recurrent non-small cell lung cancer (NSCLC) other than predominantly squamous cell histology; in combination with erlotinib for unresectable advanced, metastatic or recurrent non-squamous NSCLC with Epidermal Growth Factor Receptor (EGFR) activating mutations; in combination with interferon alfa-2a for advanced and/or metastatic renal cell cancer; in combination with carboplatin and paclitaxel for advanced (International Federation of Gynecology and Obstetrics (FIGO) stages III B, III C and IV) epithelial ovarian, fallopian tube, or primary peritoneal cancer; in combination with carboplatin and gemcitabine or in combination with carboplatin and paclitaxel for platinum-sensitive epithelial ovarian, fallopian tube or primary peritoneal cancer; in combination with topotecan, or pegylated liposomal doxorubicin for platinum-resistant recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer; and in combination with paclitaxel and cisplatin, or alternatively, paclitaxel and topotecan for persistent, recurrent, or metastatic carcinoma of the cervix. AYBINTIO® is not recommended for use in combination with paclitaxel for the treatment of adult patients with platinum resistant recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer.