BIOSIMILARS UPDATES

20 Jun 22 | CN | NMPA approves Innovent’s TYVYT® (sintilimab injection) Innovent Biologics and Eli Lilly announced that the CDE of China’s NMPA has approved the sNDA for TYVYT® (sintilimab injection) in combination with cisplatin plus paclitaxel...

11 Jun 22 | Samsung Bioepis presents Ph III eculizumab data Samsung Bioepis presented data from its Ph III trials of SB12 (eculizumab biosimilar) in paroxysmal nocturnal hemoglobinuria at the European Hematology Association 2022, reporting that...

02 Jun 22 | Civica selects Profil as clinical trial partner for affordable insulin initiative Civica announced that is has selected Profil as its clinical trial partner to support the development of its affordable insulin initiative.  In March...

24 May 22 | BR | Shanghai Henlius Biotech signs license agreement for rituximab and trastuzumab biosims Shanghai Henlius Biotech announced that it has entered into a semi-exclusive license agreement with Abbott Operations Uruguay for the...

20 May 22 | EU | Prestige Biopharma (Roche/Genentech) | HD201, trastuzumab (Herceptin®) Prestige’s trastuzumab rejected by CHMP The CHMP recommended refusing the marketing authorisations for Prestige Biopharma’s applications for trastuzumab...

16 May 22 | Alvotech (Janssen) | AVT04, ustekinumab, (Stelara®)Alvotech announces study results for AVT04, biosimilar ustekinumab Alvotech announced positive top-line results from a 3 arm, parallel design study conducted in Australia and New...

04 May 22 | Amneal published its Q1 2022 financial results, reporting a 1% increase YoY in net revenue.  Amneal announced that it plans to expand into high growth areas including biosimilars and injectables. 10 May 22 | Formycon and Athos KG...

29 Apr 22 | Merck announced that the EC has approved Keytruda® (pembrolizumab) in combination with chemotherapy (with or without bevacizumab) for the treatment of persistent, recurrent or metastatic cervical cancer in adults whose tumours...