13:44 uur 27-09-2018

Biologics-licentieaanvraag van Samsung Bioepis voor SB5 Adalimumab Biosimilar-kandidaat aanvaard voor beoordeling door de Amerikaanse Food and Drug Administration

De Biologics-licentieaanvraag voor SB5 was gebaseerd op een 52 weken durende fase 3-studie waarin SB5 werd vergeleken met het adalimumab-referentieproduct

INCHEON, Korea – (BUSINESS WIRE) – Samsung Bioepis Co., Ltd. heeft vandaag aangekondigd dat de Amerikaanse Food and Drug Administration (FDA) de Biologics License Application (BLA) onder de 351 (k) -route voor SB5, een biosimilar kandidaat die refereert aan HUMIRA® i (adalimumab) heeft geaccepteerd. De BLA voor SB5 is in juli 2018 ingediend door Samsung Bioepis.

De BLA voor SB5 was gebaseerd op gegevens afkomstig van een gerandomiseerde, dubbelblinde 52 weken durende fase 3-studie, waarbij 544 patiënten met matige tot ernstige reumatoïde artritis ondanks methotrexaat (MTX) ad random SB5 of het adalimumab-referentieproduct (ADL) kregen toegediend. In week 24 was de ACR20-respons 72,4% in de SB5-groep versus 72,2% in de ADL-groep.

Samsung Bioepis’ Biologics License Application for SB5 Adalimumab Biosimilar Candidate Accepted for Review by the U.S. Food and Drug Administration

The Biologics License Application for SB5 was based on a 52-week Phase 3 study comparing SB5 to the adalimumab reference product

INCHEON, Korea–(BUSINESS WIRE)–Samsung Bioepis Co., Ltd. today announced that the U.S. Food and Drug Administration (FDA) has accepted for review the company’s Biologics License Application (BLA) under the 351(k) pathway for SB5, a biosimilar candidate referencing HUMIRA® i (adalimumab). The BLA for SB5 was submitted by Samsung Bioepis in July 2018.

The BLA for SB5 was based on data derived from a randomized, double-blind 52-week Phase 3 study, in which 544 patients with moderate to severe rheumatoid arthritis despite methotrexate (MTX) therapy were randomized to receive either SB5 or the adalimumab reference product (ADL). At Week 24, the ACR20 response rate was 72.4% in the SB5 group versus 72.2% in the ADL group. The safety profile of SB5 was comparable to ADL up to Week 24. At Week 24, 254 patients receiving ADL were re-randomized in a 1:1 ratio to continue on ADL or transitioned to SB5, and 254 patients receiving SB5 continued to receive SB5. Up to Week 52, the efficacy, safety and immunogenicity profiles remained comparable between all three treatment groups. There were no treatment emergent issues or clinically relevant immunogenicity precipitated by alternating subjects between treatments.

Outside of the United States, SB5 has so far received regulatory approval from the European Commission, Korea’s Ministry of Food and Drug Safety, Australia’s Therapeutic Goods Administration and Health Canada.

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 late-stage 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 Humira® is a registered trademark of AbbVie Inc.

Contacts

MEDIA CONTACT:
Samsung Bioepis Co., Ltd.
Mingi Hyun
+82-31-8061-1594
mingi.hyun@samsung.com

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