Biosimilars/News

Mabion withdraws application for rituximab biosimilar in EU

Biosimilars/News | Posted 17/04/2020

Polish biologicals company Mabion Spolka Akcyjna (Mabion) has withdrawn its duplicate applications for its rituximab biosimilar, MabionCD20.

Amgevita approved in Colombia

Biosimilars/News | Posted 17/04/2020

Colombia’s National Institute of Food and Drug Monitoring (INVIMA – Instituto Nacional de Vigilancia de Medicamentos y Alimentos) has approved the first adalimumab producto bioterapéutico similar (similar biotherapeutic product).

Merck launches trastuzumab biosimilar in the US

Biosimilars/News | Posted 24/04/2020

US pharma giant Merck (known as MSD outside the US and Canada) and Korea-based Samsung Bioepis (Samsung and Biogen’s joint venture) announced in on 15 April 2020 that they had launched their trastuzumab biosimilar, Ontruzant, in the US.

EC approval for rituximab biosimilar Ruxience

Biosimilars/News | Posted 24/04/2020

On 2 April 2020, pharma giant Pfizer announced that its rituximab biosimilar, Ruxience (PF‑05280586), had received European Commission (EC) approval.

Non-originator biologicals approved in Bosnia and Herzegovina

Biosimilars/News | Posted 10/04/2020

Russian biotechnology company Biocad announced on 30 March 2020 that it had received approval for two of its anticancer non-originator biologicals in Bosnia and Herzegovina.

EMA recommends approval of etanercept biosimilar Nepexto

Biosimilars/News | Posted 03/04/2020

The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) announced on 27 March 2020 that it had recommended granting of marketing authorization for a biosimilar etanercept product.

Celltrion/Teva launch trastuzumab biosimilar Herzuma in US

Biosimilars/News | Posted 27/03/2020

Celltrion and Teva announced in March 2020 that they have launched their trastuzumab biosimilar Herzuma (trastuzumab-pkrb) in the US. Herzuma can be used to treat breast and gastric cancer and has recently been approved in Canada [1].

Celltrion launches infliximab biosimilar Remsima SC in Europe

Biosimilars/News | Posted 20/03/2020

In a successful time for Celltrion Healthcare (Celltrion), the company has launched their infliximab biosimilar Remsima in Germany and the UK.

Amgen starts phase III trial for aflibercept biosimilar

Biosimilars/News | Posted 13/03/2020

US-based biotech giant Amgen is initiating a phase III clinical trial for a biosimilar of Regeneron’s Eylea (aflibercept).

FDA accepts application for Mylan’s bevacizumab biosimilar

Biosimilars/News | Posted 06/03/2020

US-based drugmaker Mylan announced on 27 February 2020 that the US Food and Drug Administration (FDA) had accepted its application for its bevacizumab biosimilar (MYL 1402O).