Biosimilars/News
Teva and Celltrion to partner on biosimilars
Israeli generics giant Teva Pharmaceutical Industries (Teva) and South Korean biotechnology company Celltrion announced on 7 October 2016 that they had entered into an exclusive partnership for two of Celltrion’s monoclonal antibody biosimilars in the US and Canada.
Biosimilar rituximab approved in South Korea
South Korean biotechnology company Celltrion announced on 17 November 2016 that the company had received approval for its rituximab biosimilar Truxima (CT-P10) from the Korean Ministry of Food and Drug Safety (MFDS, formerly the Korea Food and Drug Administration).
Mylan and Biocon submit insulin glargine biosimilar to EMA
Generics giant Mylan Pharmaceuticals (Mylan) and Indian biosimilars major Biocon announced on 3 November 2016 that the regulatory submission for their proposed insulin glargine biosimilar had been accepted for review by the European Medicines Agency (EMA).
FDA accepts application for bevacizumab biosimilar
Biotech giant Amgen and its partner Allergan, announced on 15 November 2016 that the regulatory submission for its proposed bevacizumab biosimilar (ABP 215) had been accepted for review by the US Food and Drug Administration (FDA). The companies believe this submission is the first bevacizumab biosimilar application submitted to FDA.
EMA approves biosimilars of insulin glargine and teriparatide
The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) announced on 11 November 2016 that it had recommended granting of marketing authorization for an insulin glargine biosimilar and two teriparatide biosimilars.
Celltrion submits trastuzumab biosimilar application to EMA
South Korean biotechnology company Celltrion has, according to The Korea Herald, submitted another biosimilar application to the European Medicines Agency (EMA).
FDA accepts application for pegfilgrastim biosimilar from Coherus
Coherus BioSciences (Coherus) announced on 6 October 2016 that the US Food and Drug Administration (FDA) had accepted for review a Biologics License Application (BLA) for the company’s pegfilgrastim biosimilar candidate (CHS-1701).
Baxalta and Momenta part ways on adalimumab biosimilar
US-based biotechnology firm Momenta Pharmaceuticals (Momenta) announced on 27 September 2016 that it would regain rights to its candidate adalimumab biosimilar M923 from Baxalta, a spinoff company from Baxter International.
Biogen’s infliximab biosimilar gets UK launch
US biotechnology company Biogen has launched their biosimilar of blockbuster anti-inflammatory Remicade (infliximab) across the UK.
Pfizer to launch infliximab biosimilar Inflectra in US
Pfizer announced on 17 October 2016 that it will begin shipment of its monoclonal antibody biosimilar Inflectra (infliximab-dyyb) to the US in late November 2016.
