Biosimilars
Biosimilars approved in Chile
In Chile, the regulatory body responsible for the approval of biological medicines is the National Drug Agency (Agencia Nacional de Medicamentos, ANAMED), which is part of the Institute of Public Health of Chile (ISP), under the Ministry of Health.
AMD position statement on the use of biocomparables for psoriasis
The Mexican Academy of Dermatology (AMD) is a non-profit civil association founded in 1952 and formed by a group of relevant dermatologists dedicated to sharing experiences and keeping up to date with the latest advances in research. This group has developed the following position statement on biosimilars for psoriasis.
Australia’s PBAC recommends unrestricted benefit listing for rituximab biosimilars
Australia’s Pharmaceutical Benefits Advisory Committee (PBAC) has recommended that the Pharmaceutical Benefits Scheme (PBS) listing for the rituximab biosimilars Riximyo and Truxima be changed to ‘Unrestricted Benefit listings’.
Biosimilars: Promises made. Promises kept?
Biosimilars are biological products that are highly similar to their reference biologicals. Biosimilars are designed to have comparability with respect to quality, safety and efficacy compared to an already licensed reference biological. Most regulatory agencies, including the European Medicines Agency (EMA), do not require a full clinical dossier for a biosimilar. It is usually possible to carry out one clinical trial in one indication, with the option to extrapolate to other indications of the reference biological [1].
Canada approves filgrastim and insulin aspart biosimilars Nypozi and Kirsty
Canada’s drug regulator, Health Canada, has approved the filgrastim and insulin aspart biosimilars Nypozi and Kirsty.
Progress in the regulation of biosimilars in the EU
Analysis of regulation of biosimilars in the EU concludes that regulation is progressing as more knowledge is gained, which is reflected in the changing nature of regulatory guidelines. The authors conclude that the EU framework generates safe and effective biosimilars [1].
Advances for biotech in Korea: Samsung Bioepis, Celltrion and LG Chem
Korean companies Samsung Bioepis and Celltrion have accelerated their penetration into the global market, with a total of 11 approvals in Europe and eight in the US. In addition, Korea’s LG Chem has expanded its presence in Japan and China. This growth follows increasing investment in the biotech sector from South Korea’s government and private pharmaceutical companies [1, 2].
Biosimilars, clinical management and incentives
The aim of a study carried out by Spanish researchers was to identify and analyse policies applied in the health services to enhance uptake of biosimilars in the framework of clinical management settings [1]. Incentives, both financial and non-financial, were of particular interest for the authors. They reviewed the relevant experiences developed in different high-income countries with advanced healthcare systems. In addition, they investigated barriers to the implementation of these policies in Spain.
YLB113 etanercept biosimilar autoinjector 'safe and effective’
Analysis of the YLB113 etanercept autoinjector, a biosimilar to reference etanercept, finds a high rate of injection success and supports the safe and effective use of YLB113 [1].
China approves Factor VIII copy biological Anjian
China-based drugmaker SinoCellTech (formerly known as Shenzhou Cell) announced on 23 July 2021 that China’s National Medical Products Administration (NMPA), formerly the China Food and Drug Administration (CFDA), had approved its recombinant human coagulation factor VIII (susoctocog alfa) copy biological Anjian.
