Samsung Seeks Third Anti-TNF Biosimilar Launch In Europe
After receiving regulatory approvals in Europe for its biosimilar versions of etanercept and infliximab earlier this year, South Korea's Samsung Bioepis is now looking to add adalimumab to it and partner Biogen’s growing portfolio.
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A tense advisory committee meeting, where many of the panelists admitted they lacked a complete understanding about biosimilars and patient advocates expressed anxiety over the products, could signal difficulties with adoption and success in the marketplace.
A month after the US FDA granted approval of Celltrion's biosimilar infliximab, another South Korean firm, Samsung Bioepis, is rapidly progressing its diverse pipeline and is seeking an entry into the US market through an approval filing for its biosimilar version of the anti-inflammatory antibody. The product is already available in South Korea and recently won a green light in Europe.
Samsung Bioepis Co. Ltd. has received a marketing approval from the European Commission for its biosimilar version of Amgen Inc.'s Enbrel (etanercept), the first etanercept biosimilar to be approved by the Commission and therefore likely the first to debut in Europe. But Sandoz is close behind – the Swiss company's biosimilar etanercept was accepted by review by European regulators in December 2015.