Biosimilar

FDA Gives Nod to Fresenius Kabi’s Tyenne®: A Dual-Format Tocilizumab Biosimilar Advancement

(IN BRIEF) Fresenius Kabi announces FDA approval of Tyenne® (tocilizumab-aazg), the first tocilizumab biosimilar offering both IV and subcutaneous formulations.…

2 months ago

Novartis division Sandoz receives US FDA complete response letter regarding the Biologics Licensing Application for its proposed biosimilar rituximab

Holzkirchen, Germany, 04-May-2018 — /EuropaWire/ — Sandoz, a Novartis division, announced today that the US Food and Drug Administration (FDA) has…

6 years ago

EBRD takes part in the US$ 51 million private placement of Mabion S.A.

Participation in private placement as a cornerstone investor EBRD participates in US$ 51m equivalent private placement of Mabion Mabion is…

6 years ago

Sandoz: EMA Committee for Medicinal Products for Human Use (CHMP) adopts positive opinion for marketing authorization of infliximab

Sandoz is seeking approval of biosimilar infliximab for use in all indications of its reference medicine across gastroenterology, rheumatology and…

6 years ago

New Sandoz Biosimilar Shows Promising Equivalency Results

Sandoz proposed biosimilar adalimumab (GP2017) shown to have equivalent efficacy and a similar safety profile as reference medicine, Humira®* Comprehensive…

7 years ago