Biosimilar van trastuzamab SB3 van Samsung Bioepis aangenomen voor beoordeling door Food and Drug Administration van de VS
INCHEON, Korea–(BUSINESS WIRE)– Samsung Bioepis Co., Ltd. heeft vandaag bekendgemaakt dat de Amerikaanse Food and Drug Administration de Biologics License Application (BLA) van het bedrijf heeft aangenomen voor een beoordeling krachtens het traject 351(k) voor SB3, een kandidaat-biosimilar van Herceptin® i (trastuzumab). SB3 is de eerste oncologische biosimilar van Samsung Bioepis die is ingediend voor wettelijke goedkeuring in de Verenigde Staten. Als de kandidaat wordt goedgekeurd, wordt SB3 door Merck in de VS op de markt gezet. Merck is buiten de VS en Canada bekend onder de naam MSD.
Samsung Bioepis’ SB3 Trastuzumab Biosimilar Candidate Accepted for Review by the US Food and Drug Administration
INCHEON, Korea–(BUSINESS WIRE)– Samsung Bioepis Co., Ltd. today announced that the US Food and Drug Administration (FDA) has accepted for review the company’s Biologics License Application (BLA) under the 351(k) pathway for SB3, a biosimilar candidate referencing Herceptin® i (trastuzumab). SB3 is Samsung Bioepis’ first oncology biosimilar candidate submitted for regulatory review in the United States (US). If approved, SB3 will be commercialized in the US by Merck, which is known as MSD outside of the US and Canada.
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Christopher Hansung Ko, President & CEO of Samsung Bioepis. (Photo: Business Wire)
About Samsung Bioepis Co., Ltd.
Established in 2012, Samsung Bioepis is a biopharmaceutical company committed to realizing healthcare that is accessible to everyone. Through innovations in product development and a firm commitment to quality, Samsung Bioepis aims to become the world’s leading biopharmaceutical company. Samsung Bioepis continues to advance a broad pipeline of biosimilar candidates that includes six first-wave candidates that cover the therapeutic areas of immunology, oncology and diabetes. Samsung Bioepis is a joint venture between Samsung BioLogics and Biogen. For more information, please visit: www.samsungbioepis.com.
i Herceptin® is a registered trademark of Genentech Inc.
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Contacts
MEDIA CONTACT:
Samsung Bioepis Co., Ltd.
Mingi Hyun
+82-31-8061-1594
mingi.hyun@samsung.com