Tags : Marketing Authorization Application

Bio-Thera Reports MAA Submission to EMA for BAT1706 a Proposed

Shots: The company has submitted an MAAA for BAT1706 to EMA. Bio-Thera seeks a commercial license for all approved indications of bevacizumab in the EU Member States, Iceland, Norway, and Liechtenstein The submission of the MAA for BAT1706 marks it as the first ex-China MAA/ BLA submission. The BLA of the biosimilar for metastatic carcinoma […]Read More

Henlius Reports EMA’s Acceptance of Marketing Authorization Application for HLX02

Shots: The acceptance follows P-III study demonstrating bio-similarity data between HLX02 and reference product trastuzumab sourced from EU in 649 patients with HER2+ m-breast cancer and P-I study resulting equivalence in PK & safety studies b/w HLX02 and reference trastuzumab sourced from both EU and China In Jun’18, Henlius granted exclusive commercialization rights of HLX02 […]Read More

Prestige BioPharma Reports EMA’s Acceptance of Marketing Authorization Application for

Shots: Prestige Biopharma announces that EMA has accepted & validated MAA for its Tuznue, a biosimilar to Herceptin (trastuzumab) on May 23, 2019 Prestige’s Tuznue will be in competition with Celltrion’s Herzuma, Amgen’s Kanjinti, Merck Sharp & Dohme’s Ontruzant & Pfizer’s Trazimera in the European market, dominated by Roche’s Herceptin Tuznue (HD201) is currently evaluated […]Read More