Biosimilars
Key facts of biosimilars approval regulation in Brazil
This article provides a brief overview of the important aspects and an update on the regulatory pathways for approval of biological products in Brazil [1].
The cost savings of non-medical switching in dermatology
Non-medical switching is when a patients' therapy is changed due to reasons not linked to their health and can involve non-interchangeable drugs, potentially affecting the treatment outcomes.
Canada’s Saskatchewan province introduces biosimilars switching policy
The Canadian province of Saskatchewan is the latest to introduce a biosimilars switching policy. As of October 2022, the province joins British Columbia (BC) [1], Quebec [2], Alberta, Ontario [3], New Brunswick [4], Nova Scotia [5], and the Northwest Territories [6] in introducing biosimilars switching policies.
Progress for Lucentis (ranibizumab) biosimilars in Europe and the US
On 16 September 2022, Partners Stada Arzneimittel and Xbrane Biopharma announced that the European Medicines Agency’S (EMA) Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion for Ximluci, a biosimilar candidate referencing Lucentis (ranibizumab). In addition, on 19 September 2022 in the US, Coherus BioSciences announced that from 3 October 2022, another ranibizumab biosimilar, Cimerli (ranibizumab-eqrn) will be commercially available.
Switching from adalimumab originator and ABP501 to SB5 in arthritis patients
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.
A Canadian gastro-enterologist’s view on advising on biosimilars
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.
Bevacizumab biosimilar approvals and launch in Japan and USA
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.
Updates for European Pharmacopoeia monographs for biotherapeutic products
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 [1] 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.
Forwards for Formycon’s Keytruda and backwards for Prestige’s Herceptin
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).
Biosimilars of pembrolizumab
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).
