Biosimilars/News
Non-originator biologicals approved in Bosnia and Herzegovina
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
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
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
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
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
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).
Mylan launches anti-cancer biosimilar in the US
The US drug market receives a new oncology biosimilar as Mylan launches its trastuzumab biosimilar, Ogivri.
Mylan launches anti-cancer biosimilar in the US
Pfizer launching biosimilars in US and Japan but not in EU
In early 2020, pharma giant Pfizer announced that it was launching its rituximab biosimilar in Japan and that it would be launching three new biosimilars onto the US market.
Phase III trial started in China for eculizumab copy biological
Korea-based Samsung Bioepis (Samsung and Biogen’s joint venture) is starting a phase III clinical trial in China for a copy biological of Soliris (eculizumab), made by Alexion Pharmaceuticals (Alexion).
EMA approval for rituximab biosimilar Ruxience
The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) announced on 31 January 2020 that it had recommended granting marketing authorization for the rituximab biosimilar Ruxience.
