9 March 2020 - Celltrion said Monday that it applied for the European Medicine Agency’s commercialization approval of CT-P17, a ...
31 January 2020 - Pfizer today announced that the CHMP of the EMA has adopted a positive opinion, recommending marketing ...
25 November 2019 - European Union marketing approval is based on the phase I/III study to evaluate pharmacokinetics, efficacy and safety ...
24 September 2019 - This month, Elena Wolff-Holz, chair of the EMA’s Biosimilar Medicinal Products Working Party, together with co-authors from ...
23 September 2019 - CHMP positive opinion is based on the phase I/III study to evaluate pharmacokinetics, efficacy and safety between ...
4 September 2019 - As defined by the European Commission, the term interchangeability refers to “the possibility of exchanging one medicine ...
29 August 2019 - Although regulators rarely offer public comments on another regulator’s guidance, the European Medicines Agency (EMA) late ...
19 July 2019 - Samsung Bioepis said that the EMA has started evaluating its application to market SB8, an Avastin ...
21 June 2019 - First China-developed trastuzumab biosimilar accepted for MAA review by the EMA. ...
30 May 2019 - Pfenex and Alvogen today announced that the EMA has accepted the marketing authorisation application submitted by our ...
28 May 2019 - Prestige BioPharma announced that EMA has validated and accepted for review the marketing authorisation application for ...
26 April 2019 - European Commission approval anticipated within 90 days. ...
3 April 2019 - The European Commission granted Fresenius Kabi the marketing authorization for Idacio, an adalimumab biosimilar, for all indications ...
5 March 2019 - Samsung Bioepis has gained approval to sell bigger-size Ontruzant in Europe, the company said Tuesday. ...
19 February 2019 - Pfizer today announced the European Commission has approved Zirabev for the treatment of metastatic carcinoma of ...