Biosimilars
Adalimumab biosimilar launched in Japan
Japan-based Mochida Pharmaceutical (Mochida) announced on 25 November 2021 that its adalimumab biosimilar had been launched in Japan following the listing of the drug on the National Health Insurance (NHI).
Evidence on automatic substitution of biologicals is limited
A systematic review of the evidence on automatic substitution of biological medicines [1] finds that current research evidence is mainly based on opinion polls and surveys of low-to-moderate quality, with results that are not generalizable or suitable for guiding policy.
Patients from Uruguay request that non-interchangeability of biotherapeutics be regulated
Patients demand guarantees that authorities will not make switches of biotherapeutic drugs solely for economic reasons and without considering the medical decision. This was expressed by the Uruguay Patients Alliance at the First National Biotechnology Forum. The main objective of this forum was to create a meeting place for the academic world, patients and health authorities in the field of biotechnology and innovation.
Definition of biological terms in Latin America
To conduct a comparative study of the health registration regulations for biological and biotechnological drugs in Latin America, Ramírez-Telles et al. made an approximation, as clear as possible, of biological terms: regulatory authority of reference, biotechnological drug, reference biological drug and innovative product. Its objective was to detect the differences and what these variations entailed when comparing the following Latin American countries: Brazil, Chile, Costa Rica, Cuba, Dominican Republic, El Salvador, Guatemala, Honduras and Panama [1].
Celltrion seeks approval for bevacizumab biosimilar in Europe, US and Korea
South Korean biotechnology company Celltrion announced in October 2021 that it had applied for marketing approval for its candidate bevacizumab biosimilar (CT P16) in Europe, Korea and the US.
China accepts Bio-Thera’s application for tocilizumab copy biological BAT1806
China’s National Medical Products Administration (NMPA) has accepted a marketing authorization application for Bio-Thera Solutions’ (Bio-Thera) copy biological of tocilizumab, an immunosuppressant used in the treatment of arthritis.
Advances for Samsung Bioepis’ eculizumab and trastuzumab biosimilars
Samsung Bioepis has announced the completion of its global phase III clinical trials of a biosimilar of Soliris (eculizumab), for treating certain rare blood diseases. In addition, it also presented its results from a five-year follow-up study that showed its biosimilar Ontruzant (trastuzumab) has comparable cardiac safety profiles and long-term efficacy as the originator, Herceptin.
Concerns over Canada’s New Brunswick transition to biosimilars
Several biological medications whose patents have expired will no longer be covered under provincial drug plans of New Brunswick, Canada as of 30 November 2021. These are to be replaced by cheaper biosimilar versions; however, inflammatory disease associations have expressed concerns about the rapid transition.
Biosimilar mAb development – quality similarity considerations
Since 2013, when the first biosimilar monoclonal antibody (mAb) was approved by the European Medicines Agency (EMA), the number of approved biosimilar mAbs has been increasing dramatically [1]. The large number of approved biosimilar mAbs in both the European Union (EU) and the US makes the evaluation of these applications possible from a product quality perspective.
Regulation of the registration of biological drugs in Latin America
Biological drugs are defined as products with active ingredients produced from a biological source, whereas a biotechnological product is developed from the isolation of a gene of interest and its cloning [1].
