Following the establishment of biosimilarity, there are no regulations that require manufacturers to perform quality or clinical studies to compare biosimilar versus originator products post-approval. In an investigation published in GaBI Journal , Dr Pablo Matar examined the concept of biosimilar manufacturing ‘drift’ and product divergence .
In November 2022, Alvotech announced that the Therapeutic Goods Administration (TGA) of Australia has granted marketing authorization for its a high-concentration low-volume adalimumab, AVT02, a biosimilar referencing Humira and marketed by their partner, Cipla Australia. In addition, Stada Arzneimittel and Xbrane Biopharma announced that the European Commission granted marketing authorization for their Ximluci (ranibizumab), a biosimilar candidate referencing Lucentis.
In October 2022, Alvotech announced new advances with partners Fuji Pharma in Japan and JAMP in Canada. In addition, in September 2022, with its partner STADA, Alvotech announced the launch of Hukyndra, its high-concentration, low-volume, citrate-free formulation, biosimilar to Humira (adalimumab), in Switzerland.
Biologicals such as rituximab and trastuzumab have improved treatment outcomes for many cancers. However, due to their high economic burden, ‘highly similar’ products known as biosimilars have been developed and used. Yet, there is still concern surrounding comparability of efficacy and safety between the biosimilar and its reference biological, especially regarding patients switching from the reference to the biosimilar.
This article provides a brief overview of the important aspects and an update on the regulatory pathways for approval of biological products in Brazil .
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.
The Canadian province of Saskatchewan is the latest to introduce a biosimilars switching policy. As of October 2022, the province joins British Columbia (BC) , Quebec , Alberta, Ontario , New Brunswick , Nova Scotia , and the Northwest Territories  in introducing biosimilars switching policies.
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.
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.