NIPRO Receives FDA 510(k) Clearance for ELISIO-HX Dialyzer for Expanded Hemodialysis in the US

Shots: NIPRO CORPORATION received US FDA 510(k) clearance for its ELISIO-HX dialyzer, enabling the US commercialization of HDs (Hemodialysis powered by super high-flux membrane). The clearance became effective on July 28, 2026 ELISIO-HX features NIPRO’s proprietary super high-flux membrane technology, designed to enhance the removal of larger middle-molecule uremic toxins while maintaining albumin retention. The…

ByPrince GiriJuly 31, 2026

Key Biosimilars Events of May 2026

Shots: May 2026 saw strong biosimilar momentum with key approvals including Bevqolva (Health Canada), Langlara and Immgolis/Immgolis Intri (US FDA), Bysumlog and Dazparda (EC), and Eyzanfy (MFDS), expanding competition across oncology, diabetes, immunology, and ophthalmology. Strategic progress continued with Henlius’ FDA IND clearance for HLX05-N, alongside partnerships between IQVIA–Kexing Biopharm and Polpharma–Tuteur, supporting global development and commercialization efforts. Commercialization accelerated through the EU launches of FYB203 and Opuviz, as well as Samsung Bioepis’ ustekinumab biosimilar launch in Japan,…

ByDipanshu DixitJune 2, 2026

Samsung Bioepis Collaborates with NIPRO to Commercialize Biosimilar Candidates in Japan

Shots: Samsung Bioepis & NIPRO have entered into a license, development & commercialization agreement for various biosimilar candidates, incl. SB17, a biosimilar version of Stelara (ustekinumab) in Japan As per the deal, NIPRO will be responsible for commercialization of the biosimilar candidates in Japan, with Samsung Bioepis handling development, manufacturing & supply activities Ustekinumab is…

ByRidhi RastogiJune 9, 2025

NIPRO Receives FDA 510(k) Clearance for ELISIO-HX Dialyzer for Expanded Hemodialysis in the US

Key Biosimilars Events of May 2026

Samsung Bioepis Collaborates with NIPRO to Commercialize Biosimilar Candidates in Japan

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