Samsung Bioepis' Imraldi (Adalimumab) Recommended For Approval By EMA

INCHEON, Korea--(BUSINESS WIRE)--Samsung Bioepis Co., Ltd. today announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion on Imraldi^®, a biosimilar candidate referencing Humira^®1(adalimumab), for rheumatoid arthritis, juvenile idiopathic arthritis, axial spondyloarthritis, psoriatic arthritis, psoriasis, pediatric plaque psoriasis, adult and adolescent hidradenitis suppurativa, Crohn’s disease, pediatric Crohn’s disease, ulcerative colitis and uveitis.

The CHMP’s positive opinion will now be referred to the European Commission (EC) which will review and decide on the grant of a marketing authorization for Imraldi^®. If a marketing authorization is granted by the EC, Imraldi^® will be commercialized in the European Union (EU) by Biogen.

“We welcome the EMA’s positive recommendation for Imraldi, which brings us a step closer to delivering a lower-cost, high-quality autoimmune treatment option to patients across Europe,” said Christopher Hansung Ko, President & CEO of Samsung Bioepis. “Through relentless process innovation and an uncompromising commitment to quality, we remain dedicated to advancing one of the industry's strongest biosimilar pipelines, so that more patients and healthcare systems across Europe will benefit from biosimilars.”

The Marketing Authorization Application (MAA) for Imraldi^® was based on data derived from a randomized, double-blind 52-week Phase III study, in which 544 patients with moderate to severe rheumatoid arthritis despite methotrexate (MTX) therapy were randomized to receive either Imraldi^® or the adalimumab reference product (ADL). At Week 24, the ACR20 response rate was 72.4% in the Imraldi^® group versus 72.2% in the ADL group. The safety profile of Imraldi^® 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 switch to Imraldi^®, 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 switching from ADL to Imraldi^®.

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.

¹ Humira^® is a registered trademark of AbbVie Inc.