BioBlast®

The Korea Herald reported that Samsung Bioepis has secured a total of 10 biosimilar products on its 10^th year anniversary.  Six biosimilars have been approved globally: infliximab, etanercept, adalimumab, trastuzumab, bevacizumab and ranibizumab.  Eculizumab has recently completed its Ph III clinical trial, and three other biosimilar candidates are under Ph III trials.

Samsung Bioepis announced that SB12 (proposed eculizumab biosimilar) met all the endpoints in a Ph I study.

Korea Biomedical Review announced that Samsung Bioepis has completed Ph III trials of SB12 (proposed eculizumab biosimilar) for the treatment of paroxysmal nocturnal hemoglobinuria.

Biopharma supplier Alexion announces it will be acquired by AstraZeneca. The acquisition is expected to close in Q3 2021 for total consideration to Alexion shareholders of $39bn. Under the deal, AstraZeneca will acquire Alexion’s pipeline of 11 molecules, as well as Alexion’s blockbuster products Soliris® (eculizumab) and Ultomiris® (ravulizumab).

In a filing to the Securities and Exchange Commission, Alexion announces it has settled its eculizumab dispute with Amgen. Under the agreement, Amgen will receive a non-exclusive, royalty-free license to market its product from 01 March 2025.

Samsung and AffaMed announce Chinese approval for Phase III trials of eculizumab candidate.

Alexion reveals that the EPO denied two patent applications relating to its eculizumab product, as they await the full written response.

US Patent and Trial Board commences an inter partes review of Alexion’s eculizumab patents following Amgen’s claims that they were anticipated or obvious.

Samsung Bioepis commences patient enrolment for Phase III clinical study of eculizumab biosimilar candidate, SB12.

Selexis announces first biosimilar eculizumab approval in Russia through partnership with Generium. 

Samsung Bioepis partners with C-Bridge to commercialise biosimilars in China. Under the deal, C-Bridge will develop a new company, AffaMed Therapeutics to launch candidates such as ranibizumab, eculizumab and trastuzumab biosimilars.