Shots:
Regulatory momentum remained strong, with key biosimilar launches and approvals including Celltrion’s Remsima IV (EU) and Avtozma SC (US), Teva’s FDA-approved Ponlimsi, Japan’s approval of tocilizumab BS MA by Mochida Pharmaceutical and AYUMI Pharmaceutical, and IND clearance for HLX18 by National Medical Products Administration.
Strategic partnerships expanded access, led by Samsung Bioepis–Sandoz collaboration, Formycon’s aflibercept settlement deal with Regeneron Pharmaceuticals and Bayer, and Bio-Thera…
Shots:
The US FDA has approved Ponlimsi, a biosimilar version of Prolia (denosumab), for all indications of the reference product
Approval was based on extensive clinical data, incl. analytical & clinical studies, which showed comparable efficacy, safety, & immunogenicity of Ponlimsi to the reference product
Additionally, Teva’s biosimilar of Xolair (omalizumab) was accepted for review…
Shots:
The EC has approved Ponlimsi & Degevma, biosimilar versions of Prolia & Xgeva (denosumab), respectively, following the CHMP positive opinion for bone health treatments
Approval was based on comprehensive analytical, preclinical, & clinical data, demonstrating comparable quality, safety, & efficacy of Ponlimsi & Degevma to the reference product
Ponlimsi & Degevma are anti-RANKL monoclonal…

