Biologics for the treatment of human disease are unique and complex molecules. Over the last decade, the development of biosimilars, drugs that are highly similar to the original reference biologic, have been developed. These drugs are now being approved and have become commercially available around the world. [1]
This week, the Committee for Medicinal Products for Human Use CHMP), formerly known as Committee for Proprietary Medicinal Products, the European Medicines Agency’s (EMA) committee responsible for the agency’s opinions about medicinal products for human use, confirmed that it has adopted a positive opinion for Samsung Bioepis’ biosimilar candidate referencing of Genentech/Roche bevacizumab (Avastin®) during its June 2020 meeting. [2]
The biosimilar called Aybintio® has been recommended for approval for the treatment of the same types of cancer as reference bevacizumab in the European Union, 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. [3][4]
Following the positive opinion, the drug file will now be reviewed by the European Commission (EC) to decide on granting marketing authorization for the biosimilar. This process normally takes two to three months.
“We are delighted by our progress in expanding patient access to high-quality biopharmaceuticals,” noted 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 the 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 without clinically meaningful differences.
Aybintio® is Samsung Bioepis’ second oncology biosimilar to be recommended for marketing authorization by the European Medicines Agency.
In September 2019 Samsung Bioepis submitted a Biologics License Application (BLA) for Aybintio®. The drug is currently under review by the U.S. Food and Drug Administration (FDA).
European Medicines Agency
In 2019 the European Medicines Agency relocated to Amsterdam. This was a direct consequence of the United Kingdom’s withdrawal from the European Union and was confirmed in 2017 following a secret ballot involving the 27 EU Member States. The members chose The Netherlands over 18 other countries who bid to become the agency’s new home.
Reference
[1] US Food and Drug Administration, Center for Drug Evaluation and Research (CDER), Center for Biologics Evaluation and Research (CBER). Scientific Considerations in Demonstrating Biosimilarity to a Reference Product. Guidance for Industry. April 2015. Online. Last accessed on June 25, 2020. Accessed June 25, 2018.
[2]Avastin® is a registered trademark of Genentech Inc. [Prescribing Information]
[3 ]European Medicines Agency. Avastin Summary of Product Characteristics. Online. Last accessed on June 25, 2020.
