Biosimilars/News
Etanercept biosimilar submitted for approval in Japan
Japan-based Mochida Pharmaceutical (Mochida) has submitted an application for marketing approval for an etanercept biosimilar (LBEC0101) to the Japanese medicines regulatory agency – the Pharmaceuticals and Medical Devices Agency (PMDA).
EMA approval for adalimumab biosimilars Amgevita and Solymbic
The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) announced on 27 January 2017 that it had recommended granting of marketing authorization for the adalimumab biosimilars Amgevita and Solymbic.
Sandoz withdraws biosimilar pegfilgrastim application
The European Medicines Agency (EMA) announced on 27 January 2017 that Sandoz had withdrawn the marketing application for its pegfilgrastim biosimilar (Zioxtenzo), after the agency expressed doubts about its biosimilarity and manufacturing.
Boehringer Ingelheim submits biosimilar adalimumab application to both EMA and FDA
Germany-based Boehringer Ingelheim Pharmaceuticals (Boehringer Ingelheim) announced on 18 January 2017 that its candidate adalimumab biosimilar (BI 695501) had been accepted for regulatory review by both the European Medicines Agency (EMA) and the US Food and Drug Administration (FDA).
Merck Group starts phase III trial for adalimumab biosimilar
Germany’s Merck KGaA (Merck Group) announced on 2 March 2016 that it had started a phase III clinical trial for its adalimumab biosimilar (MSB11022) in patients with chronic plaque psoriasis.
Biosimilar adalimumab application submitted to EMA
Biotech giant Amgen announced on 4 December 2015 that it had submitted an application for marketing approval for its adalimumab biosimilar (ABP 501) to the European Medicines Agency (EMA).
Amgen submits biosimilar adalimumab application to FDA
Biotech giant Amgen announced on 25 November 2015 that it had submitted an application for marketing approval for its adalimumab biosimilar (ABP 501) to the US Food and Drug Administration (FDA).
Venezuelan approval for Celltrion’s Remsima
Celltrion announced on 29 April 2015 that it had received approval for its infliximab bioterapéuticos similares from the Venezuelan medicines agency, the Instituto Nacional de Higiene ‘Rafael Rangel’ (INHRR National ‘Rafael Rangel’ Institute of Hygiene).
The latest biosimilars agreements
Biosimilar is still the hottest subject around. Just a few of the latest collaborations for the development of biosimilars include agreements made on 6 November 2012 between AET BioTech and BioXpress Therapeutics; Oncobiologics and Boston Oncology; ProCognia and UniTargetingResearch; and the Innovent Biologics and Pharmatech Associates agreement made on 1 November 2012.
Japanese firms developing biosimilars
Japanese firms are definitely not dragging their heels when it comes to biosimilars. The latest agreement for biosimilar development involves LG Life Sciences (LGLS) and Mochida Pharmaceutical (Mochida), while joint venture Fujifilm Kyowa Kirin Biologics has announced it is to initiate development of a biosimilar version of bevacizumab.
