Samsung Bioepis Receives European Commission Approval for AYBINTIO® (Bevacizumab)
We are proud to announce our second oncology biosimilar approval in Europe, said Christopher Hansung Ko, President and Chief Executive Officer, Samsung Bioepis.
- AYBINTIO® is approved for the treatment of the same types of cancer as reference bevacizumab (AVASTIN®i)
- AYBINTIO® is Samsung Bioepis’ fifth biosimilar to be approved by the European Commission
INCHEON, Korea, Aug. 20, 2020 (GLOBE NEWSWIRE) -- Samsung Bioepis Co., Ltd. today announced that the European Commission (EC) has granted marketing authorization for AYBINTIO® (bevacizumab) for the treatment of the same types of cancer as reference bevacizumabii,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.
“We are proud to announce our second oncology biosimilar approval in Europe,” said Christopher Hansung Ko, President and Chief Executive Officer, Samsung Bioepis. “Approval of AYBINTIO provides another treatment option for patients with certain type of cancers enabling wider access to those in need.”
AYBINTIO® is Samsung Bioepis’ fifith biosimilar approved for use in Europe following BENEPALI™ (etanercept), FLIXABI™ (infliximab), ONTRUZANT® (trastuzumab), and IMRALDI™ (adalimumab). EC approval 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. This data demonstrated that AYBINTIO® and reference bevacizumab are highly similar with no clinically meaningful differences.
AYBINTIO® offers a more sustainable solution for healthcare systems in Europe and is part of Samsung Bioepis’ patient-centric approach to the development and continuous supply of quality biologics for patients. Over 129,000 patient years have been treated by Samsung Bioepis’ biosimilars in France, Germany, Italy, Spain and the United Kingdomiv, and AYBINTIO® is set to expand this even further.
About Samsung Bioepis Co., Ltd.
Established in 2012, Samsung Bioepis is a biopharmaceutical company committed to realizing healthcare that is accessible to everyone. Through innovations in product development and a firm commitment to quality, Samsung Bioepis aims to become the world's leading biopharmaceutical company. Samsung Bioepis continues to advance a broad pipeline of biosimilar candidates that cover a spectrum of therapeutic areas, including immunology, oncology, ophthalmology and hematology. Samsung Bioepis is a joint venture between Samsung BioLogics and Biogen. For more information, please visit: www.samsungbioepis.com and follow us on social media – Twitter, LinkedIn.
MEDIA CONTACT
Yoon Kim: +82-31-8061-1783, [email protected]
Evelyn Hong: +82-31-8061-1215, [email protected]
________________________
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.
iv Data source from IQVIA 2019. Analysis by Samsung Bioepis, patient years calculated for Nov 2018-Oct 2019 for etanercept, infliximab, adalimumab, and trastuzumab.
