Biosimilars
Samsung Bioepis launches Ontruzant in Brazil
South Korean biotechnology company Samsung Bioepis has announced the launch of their trastuzumab biosimilar Ontruzant in Brazil. The product was approved by the Brazilian health agency in May 2019.
Duopharma to establish Malaysia’s first commercial biosimilar facility
Malaysia-based manufacturer Duopharma Biotech aims to establish Malaysia’s first commercial biosimilar production facility. The company is also working to achieve halal certification for its erythropoietin biosimilar, Erysaa.
Cadila Pharmaceuticals launches two similar biologics in India
Indian generics maker Cadila Pharmaceuticals Ltd (Cadila) has launched two new similar biologics in the country: Bevaro (bevacizumab) and Ritucad (rituximab).
Celltrion’s biosimilars effective against gastric cancer and B-cell lymphoma
Recent clinical trial results confirm that Celltrion’s biosimilars Herzuma (trastuzumab) and Truxima (rituximab) are effective in the treatment of gastric cancer and B-cell lymphoma, respectively.
EC approval for trastuzumab biosimilar Zercepac
The European Commission (EC) has granted marketing authorization for the trastuzumab biosimilar Zercepac (HLX02) on 27 July 2020. The product is produced by the Shanghai Henlius Biopharmaceutical Co Ltd (Henlius), making it the first China-made biosimilar to receive approval in Europe.
WHO prequalifies Celltrion’s trastuzumab biosimilar Herzuma
The World Health Organization (WHO) has prequalified Celltrion Healthcare’s second biosimilar, a trastuzumab biosimilar sold as Herzuma.
Monoclonal antibody biosimilars and cancer in the EU
Spanish researchers investigated the current status of biosimilar monoclonal antibodies (mAbs) in the European Union (EU) by reviewing the regulatory pathway, the rationale for extrapolation and switching and the current status and future perspectives of the biosimilars approved in the EU [1].
The biosimilars market in Latin America: a summary
A review of the biosimilars market in Latin America [1] finds that Argentina, Brazil and Mexico have the largest number of approved similar biotherapeutic products (SBPs), while information in other countries is more limited. The review recommends investment in biotechnology hubs and further development of regulation on biological drugs.
EMA recommends approval of bevacizumab biosimilar Equidacent
The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) announced on 23 July 2020 that it had recommended granting of marketing authorization for the bevacizumab biosimilar Equidacent, which is produced by Centus Biotherapeutics, a joint venture between AstraZeneca and Fujifilm Kyowa Kirin Biologics
Clinical trials for trastuzumab biosimilars
Roche’s originator trastuzumab biological (Herceptin) was approved by the US Food and Drug Administration (FDA) in September 1998 and by the European Medicines Agency (EMA) in August 2000 [1]. The patents on Herceptin expired in Europe in July 2014 and in the US in June 2019 [1]. This has led to biosimilars of trastuzumab being developed.
