Samsung Bioepis Initiates Phase 3 Clinical Trial for SB16, Proposed Biosimilar to Prolia (Denosumab)

INCHEON, Korea – December 14, 2020 – Samsung Bioepis Co., Ltd. today announced the initiation of Phase 3 clinical trial for SB16, the company’s proposed biosimilar referencing Prolia (denosumab). The Phase 3 clinical trial for SB16 (denosumab) is a randomized, double-blind, multicenter study to evaluate the efficacy, safety, pharmacokinetics (PK), pharmacodynamics (PD), and immunogenicity of SB16 compared to Prolia in 432 women with postmenopausal osteoporosis. More information on this study is available at (NCT04664959).
In October 2020, Phase 1 clinical trial for SB16 was initiated to compare the PK, PD, safety, tolerability, and immunogenicity between SB16 and Prolia in healthy volunteers.
As of December 2020, Samsung Bioepis has three biosimilar candidates – SB12 (eculizumab), SB15 (aflibercept), and SB16 (denosumab) – in Phase 3 clinical development.
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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 cover a spectrum of therapeutic areas, including immunology, oncology, ophthalmology and hematology. Samsung Bioepis is a joint venture between Samsung BioLogics and Biogen. For more information, please visit: and follow us on social media– TwitterLinkedIn.
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Parag Narang is a Digital Marketing Associate at PharmaShots, a division of Octavus Consulting. He manages the digital marketing as well as the designing ideas for PharmaShots. He has a degree in Bachelor of Business Administration along with Post Graduate Program in Management (Marketing). Parag manages all the social media handles very well since he has a good experience in Marketing & Sales.

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