Biosimilar Clinical Updates



Over the past two weeks, there have been a number of announced clinical studies and updates from biosimilar developers around the world.

On November 9, Shanghai based Henlius Biotech, Inc. announced the start of its Phase I clinical trial of HLX14, the company’s biosimilar to Prolia® (denosumab).  According to the announcement, the Phase I trial will consist of two parts.  Part 1 will consist of comparing the pharmacokinetics, pharmacodynamics, safety, tolerability, and immunogenicity of HLX14 to EU-sourced denosumab.  Part 2 of the trial is aimed at establishing pharmacokinetic bioequivalence of HLX14 and US-, EU-, and CN-sourced denosumab.

Also on November 9, Formycon AG and Bioeq GmbH announced the start of its Phase III clinical trial of FYB202, their biosimilar candidate to Stelara® (ustekinumab).  According to the announcement, the Phase III trial is aimed at demonstrating the comparability of FYB202 to the reference product Stelara® in terms of efficacy, safety, and immunogenicity in patients with moderate to severe psoriasis vulgaris.

On November 11, Samsung Bioepis Co., Ltd. announced one-year results from their Phase III study on SB11, the company’s proposed biosimilar to Lucentis® (ranibizumab), in patients with neovascular age-related macular degeneration.  According to Hee Kyung Kim, Senior Vice President and Clinical Sciences Division and Regulatory Affairs Team Leader at Samsung Bioepis, “The 52-week data confirms SB11 has equivalence in efficacy and pharmacokinetics (PK) as well as a comparable safety and immunogenicity profile with the reference product.”

DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

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