The introduction and availability of biosimilars entails a considerable increase in the patient access as well as a decrease in the patient cost. Thus, biosimilars could be the answer to the economic impact of the reference biological.
Acting as a ‘trusted advisor’ when answering questions about biological and biosimilar products is important for Canadian physician, Dr Dustin Loomes reported in a recent article.
On 27 and 28 September 2022, Celltrion announced that its oncology biosimilar bevacizumab, Vegzelma, has been approved in Japan and the US. In October 2022, Amneal Pharmaceuticals, also announced the launch of Alymsys (bevacizumab-maly) in the US.
The European Pharmacopoeia produces monographs for biotherapeutic products that are publicly available and considered the standard for defining the quality of these medicines. A recent study published in GaBI Journal  examines whether the challenges posed by complex products such as the introduction of biosimilars, have been met by new elements that have been added to the monographs.
On 19 September 2022, Formycon announced details of a project to produce a biosimilar of Keytruda (pembrolizumab). This followed news that, on 16 September 2022, Prestige Biopharma withdrew the Marketing Authorization Application (MAA) for their Herceptin Biosimilar, Tuznue, submitted to the European Medicines Agency (EMA).
Pembrolizumab is a humanized (from mouse) monoclonal antibody that binds to, and blocks PD-1 located on lymphocytes. It is an anticancer medication used in the treatment of melanoma, lung cancer, head and neck cancer, Hodgkin lymphoma, urothelial cancer (cancer of the bladder and urinary tract) and renal cell carcinoma (kidney cancer).
On 6 September 2022, Fresenius Kabi announced that they had received approval from the US Food and Drug Administration (FDA) for their pegfilgrastim biosimilar, Stimufend (pegfilgrastim-fpgk).
The biosimilar regulatory scenario is very diverse and varies widely in the large group of Latin American countries. Authors Teran et al. presented some recommendations for making biosimilar regulations in Latin America more homogeneous and comprehensive .
On 19 September 2022, Sandoz announced positive results following its ROSALIA I/III clinical trial study for its proposed biosimilar denosumab. This follows the August announcement that Lannett Company successfully completed subject dosing in the clinical trial of its biosimilar insulin glargine.
The European Medicines Agency (EMA) and the Heads of Medicines Agencies (HMA) issued on 19 September 2022 a joint statement confirming that biosimilar medicines approved in the European Union (EU) are interchangeable with their reference medicine or with an equivalent biosimilar. This will allow more patients to have access to biological medicines necessary for treating diseases such as cancer, diabetes and rheumatic diseases.