Samsung Bioepis Receives EU Approval for Aybinitio (Bevacizumab) Biosimilar

Compiled by Keke

On August 20, Samsung Bioepis announced that the European Commission (EC) has granted marketing authorization for Aybinitio (bevacizumab) for the same indications as the reference product Avastin, including metastatic colorectal cancer (mCRC), metastatic breast cancer (mBC), non-small cell lung cancer (NSCLC), advanced and/or metastatic renal cell carcinoma, epithelial ovarian cancer, fallopian tube cancer, primary peritoneal cancer, and cervical cancer.

Aybinitio is the fifth biosimilar approved for Samsung Bioepis in Europe, following the previous four biosimilars: BENEPALI (etanercept), FLIXABI (infliximab), ONTRUZANT (trastuzumab), and IMRALDI (adalimumab).

The EC’s approval of Aybinitio was based on comprehensive data and evidence, including pharmacokinetic analyses, clinical data, and pharmacological and toxicological data. These data demonstrated that Aybinitio is highly similar to the reference medicinal product, with no clinically meaningful differences.

Specifically, Aybinitio is recommended for the treatment of the following types of cancer:

Chemotherapy Combination for Fluorouracil-Based Treatment of mCRC;

Combined with paclitaxel for the treatment of mBC;

In combination with platinum-based agents for the treatment of unresectable advanced metastatic or recurrent non-small cell lung cancer (NSCLC), predominantly of squamous cell histology;

In combination with erlotinib for the treatment of epidermal growth factor receptor (EGFR) activation mutation-positive, unresectable advanced metastatic or recurrent non-squamous NSCLC;

Combined Interferon α-2a Treatment for Advanced and/or Metastatic Renal Cell Carcinoma;

Combination therapy with carboplatin and paclitaxel for the treatment of advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer;

Combination of carboplatin and gemcitabine or combination of carboplatin and paclitaxel for the treatment of platinum-sensitive epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal cancer;

In combination with topotecan or pegylated liposomal doxorubicin for the treatment of platinum-resistant recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer;

In combination with paclitaxel and cisplatin, or in combination with paclitaxel and topotecan, for the treatment of persistent, recurrent, or metastatic cervical cancer.

It should be noted that Aybinitio is not recommended for use in combination with paclitaxel for the treatment of adult patients with platinum-resistant recurrent epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal cancer.

Avastin, the originator drug from Aybinitio, is a best-selling oncology therapy by Roche. Approved by the U.S. FDA in 2004, it was the first anti-angiogenic agent approved in the United States. By inhibiting vascular endothelial growth factor (VEGF), Avastin blocks blood supply to tumors, thereby suppressing tumor metastasis and enhancing the efficacy of chemotherapy. However, in recent years, Avastin has gradually lost market share due to the approval of biosimilars. In September 2017, the FDA approved Mvasi, developed by Amgen and Allergan, as the first bevacizumab biosimilar and the first oncology biosimilar ever approved, with a price 15% lower than that of the originator drug. Mvasi received approval in the European Commission (EC) in January 2018. In February 2019, the EC further approved Pfizer’s bevacizumab biosimilar, ZIRABEV. In December of the same year, China’s National Medical Products Administration (NMPA) approved Qilu Pharmaceutical’s bevacizumab biosimilar (Ankeda), marking the first domestically approved bevacizumab biosimilar in China.

Reference Source: Samsung Bioepis Receives European Commission Approval for AYBINTIO® (Bevacizumab)