(Health Korea News / Lee Chang-yong) Prestige Biopharma has received the green light to enter the European ‘Herceptin’ biosimilar market.
Prestige Biopharma announced on the 25th (local time) that the Committee for Medicinal Products for Human Use (CHMP) under the European Medicines Agency (EMA) recommended marketing approval for its breast cancer treatment ‘Tuznue (HD201)’. ‘Tuznue’ is a biosimilar of the blockbuster breast cancer treatment Herceptin developed by Roche.
With this, Prestige Biopharma has become the third domestic company to enter the European biosimilar market, following Celltrion and Samsung Bioepis.
Previously, Prestige Biopharma had applied for product approval for ‘Tuznue’ to the CHMP in July 2023. In December of the same year, the CHMP sent Prestige Biopharma the questionnaire required for review. Prestige Biopharma submitted a response to the questionnaire in March, and two months later, the CHMP notified that ‘there are no major objections related to the product approval of HD201.’
A Prestige Biopharma official said, “As we have received a recommendation for marketing approval from the CHMP, we expect to obtain final marketing authorization from the European Commission (EC) in the near future,” and “We plan to pursue a European sales license-out agreement with a marketing and distribution network within Europe.”
‘Tooznew’ will be produced by Prestige Biologics, an affiliate of Prestige Biopharma. Prestige Biologics Osong Campus obtained EU-GMP certification in February 2022.
Meanwhile, U.S. market research firm Acumen forecasted that the global market size of Herceptin biosimilars would grow 23.2% annually from KRW 2.49 trillion in 2021 to KRW 15.63 trillion in 2030.
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Source: www.hkn24.com
