Samsung Bioepis’ Aybintio is expected to heat up biosimilars competition referencing Roche’s Avastin (ingredient: bevacizumab) in Europe.
The joint venture between Samsung BioLogics and U.S. firm Biogen said Aybintio won a positive opinion of the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) on Friday.
|Samsung Bioepis heats up the competition of biosimilars referencing Roche’s Avastin (ingredient: bevacizumab) in Europe. (Samsung Bioepis)|
Roche’s Avastin, the original drug, has indications for metastatic colorectal cancer, non-small cell lung cancer (NSCLC), and metastatic breast cancer in Europe.
Avastin sold 7.07 billion Swiss francs ($7.46 billion) around the world in 2019. Among them, one-fourth, or 1.79 billion Swiss franc sales, came from Europe.
As the substance patent on Avastin expired in January last year in Europe, and July in the U.S., pharmaceutical firms have intensely competed to release biosimilars.
Mvasi, jointly developed by Amgen and Allergan, is making a foray into the U.S. and European markets. After winning the license in the U.S. in 2017, and in Europe in 2018, the drug was released in the U.S. market in July last year.
In February last year, Pfizer obtained the nod from the European Commission (EC) for Zirabev, the second bevacizumab biosimilar in Europe.
Boehringer Ingelheim completed the phase-3 trial on bevacizumab biosimilar BI 695502 last year.
In Korea, Celltrion is conducting a global phase-3 study on CT-P16, a bevacizumab biosimilar.
Samsung Bioepis earned the CHMP’s positive opinion 11 months after the EMA began the drug review in July last year. The company is waiting for the EC’s final approval to release Aybintio.
It generally takes two to three months from the positive opinion to approval.
“Winning the CHMP’s positive opinion for Aybintio proved the company’s R&D capabilities in the global market and opened the possibility to expand the treatment benefit for cancer patients through high-quality biopharmaceutical products,” Samsung Bioepis CEO Ko Han-sung said.
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