Biosimilars/News
FDA approves trastuzumab biosimilar Ontruzant
On 18 January 2019, the US Food and Drug Administration (FDA) approved the trastuzumab biosimilar, Ontruzant (trastuzumab-dttb), for the treatment of patients with breast and gastric cancer.
CKD Pharma’s darbepoetin alfa biosimilar launched in Japan
On 4 December 2018, South Korean drugmaker Chong Kun Dang Pharmaceutical (CKD Pharma) announced that it had received approval for its second-generation anaemia biosimilar, CKD‑11101 (darbepoetin alfa).
EMA approval for bevacizumab biosimilar Zirabev
The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) announced on 13 December 2018 that it had recommended granting marketing authorization for the bevacizumab biosimilar Zirabev.
Trastuzumab and agalsidase beta biosimilars launched in Japan
Japanese firms have announced the launch of trastuzumab and agalsidase beta biosimilars in Japan on 28 November 2018.
Biosimilars launched in the US at a significant discount
Epoetin alfa and pegfilgrastim biosimilars have been launched in the US at a significant discount compared to their originators.
FDA approves first rituximab biosimilar Truxima
On 28 November 2018, the US Food and Drug Administration (FDA) approved its first rituximab biosimilar, Truxima (rituximab-abbs), the first biosimilar for the treatment non-Hodgkin’s lymphoma (NHL).
EC approval for pegfilgrastim biosimilars Pelmeg and Ziextenzo
In November 2018, pegfilgrastim biosimilars, Pelmeg and Ziextenzo, received European Commission (EC) approval.
Tanvex BioPharma submits filgrastim biosimilar to FDA
Taiwan-based biosimilars developer Tanvex BioPharma (Tanvex) announced on 1 October 2018 that it had submitted its first biosimilar application to the US Food and Drug Administration (FDA). The application is for its proposed filgrastim biosimilar TX01.
Insulin glargine biosimilars launched in UK and South Korea
November 2018 has seen the launch of insulin glargine biosimilars in both the UK and South Korea.
Another adalimumab copy biological accepted for review in China
The China National Drug Administration (CNDA), formerly the China Food and Drug Administration (CFDA) has accepted another application for approval of an adalimumab copy biological, this time from Innovent Biologics (Innovent).
