Tag Archives: Biosimilar

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 issued a complete response letter (CRL) regarding the Biologics Licensing Application (BLA) for its proposed biosimilar rituximab. Sandoz stands behind … Read the full press release

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 leading biotechnology company in Poland EBRD to invest US$ 18 million (PLN 61.4 million) LONDON, 26-Mar-2018 — /EuropaWire/ — The EBRD … Read the full press release

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 dermatology Positive opinion is based on comprehensive clinical and non-clinical data that is expected to confirm that Sandoz biosimilar infliximab … Read the full press release

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 development program show potential of GP2017 to treat inflammatory diseases, such as rheumatoid arthritis, inflammatory bowel disease and plaque psoriasis … Read the full press release