Another beval-beaded monobial-like drug has been approved by the European Union.

On August 20th Samsung Bioepis announced that the European Commission (EC) had granted its Aybinitio (Beval pearl monoanti) licence for the same adaptive disorders as the original drug Avastin, including metastatic colon or rectal cancer (mCRC), metastatic breast cancer (mBC), non-small cell lung cancer (NSCLC), advanced and/or metastatic renal cell carcinoma, epithelitis ovarian cancer, fallopian tube cancer, primary peritina cancer and cervical cancer.
Aybinitio is Samsung Bioepis's fifth biosymproid drug approved in Europe, the first four biosymplic drugs being BENEPALI (Inasip), FLIXABI (Inflix monoanti), ONTRUZANT (Qutozhu monoanti) and IMRALDI (Adamo monoanti).
EC's approval of Aybinitio is based on comprehensive data and evidence support, including pharmacodynamic analysis, clinical data, and pharmacological and toxicology data.
data show that Aybinitio is highly similar to the original drug, with no clinical differences.
specifically, Aybinitio will be recommended for the following types of cancer treatment: mCRC chemotherapy combination based on fluorouracil therapy; Combined treatment with yew alcohol mBC; combined treatment with platinum drugs for late metastatic or relapsed NSCLC, mainly squamous cell histology; combined erotinib treatment epidermic growth factor subject (EGFR) activation mutation, non-removable late metastasis or recurrence non-squamous NSCLC; and combined interferon alpha-2a treatment of advanced and/or metastatic renal cell carcinoma; Combined carptin and yew alcohol to treat advanced ovarian epithelyl, fallopian tubes or primary peritiotic cancer; combined carptain and gacytamin or combined carpul to treat platinum-sensitive epitheliotic ovarian cancer, fallopian tube cancer or primary peritina cancer; combined topological tyrocon or poly Ethylene glycol lipid aminocin is used to treat platinum-resistant relapsed epithelial ovaries, fallopian tubes, or primary peritina cancer;
note that Aybinitio is not recommended in association with yew alcohol for the treatment of adult patients with platinum-resistant relapsed ovarian epithelyl, fallopian tube or primary peritina cancer.
Aybinitio's original drug, Avastin, is a best-selling drug for Roche's cancer treatment, approved by the FDA in 2004, and is the first drug approved in the United States to inhibit tumor angiogenesty, blocking the blood supply to tumors by inhibiting the role of endotranstal growth factors in blood vessels, inhibiting the spread of tumors in the body and enhancing the effectiveness of chemotherapy.
but in recent years Avastin has gradually lost market due to the approval of biosynthic drugs.
September 2017, the FDA approved the first biosynthic drug for beva beads, and the first approved biosynthic drug for tumors, Mvasi from Amgen and Eljian, at a 15 percent lower price than the original drug.
in January 2018, Mvasi was approved at EC.
February 2019, EC approved Pfizer's Beval pearl monobial-like drug ZIRABEV.
of the same year, the State Drug Administration approved Qilu Pharmaceutical's Beval pearl monoantigen (Anda), becoming the first domestic approved beval bead single anti-biosimilar drug.
source: Samsung Bioepis Receives European Commission Approval for AYBINTIO ® (Bevacizumab)