The US Food and Drug Administration (FDA) has approved the adalimumab biosimilar Yusimry (adalimumab-aqvh) and the insulin glargine biosimilar Rezvoglar (insulin glargine-aglr) [1].

A study published in 2021 and carried out by Ramírez-Telles et al. examined the immunogenicity, pharmacovigilance and legal documentation of biological and biotechnological drugs as aspects required in the regulations for the registration of these products. This study was conducted in nine Latin American countries – Brazil, Chile, Costa Rica, Cuba, Dominican Republic, El Salvador, Guatemala, Honduras and Panama – that currently have a regulatory framework for their registration [1].

In Ecuador, the regulatory body for the approval of biologicals is the National Agency for Regulation, Control and Health Surveillance (ARCSA).

A review of the Top 10 most read articles reveals that biosimilars are still of most interest to readers. Some of the most memorable events for biosimilars in 2021 were recommendations for biosimilar approvals by the European Medicines Agency (EMA) and by China’s National Medical Products Administration (NMPA), formerly the China Food and Drug Administration (CFDA), as well as summaries of biosimilar approvals in Uruguay and Paraguay. Other subjects of interest included naming for biosimilars in the US, the interchangeability of EU biosimilars, Federal purchases of biologicals for cancer in Brazil. Finally, how patent litigation creates barriers to US biosimilar market growth and how competition from biosimilars drives price reductions for biologicals in France was also of interest to readers.

Australia’s parliament has approved a new bill aimed at mitigating drug shortages in the country and ensuring that innovative medicines are accessible, available and affordable for all Australians.

Generic medicines in Europe can be approved either centrally via the European Medicines Agency (EMA) or nationally via the local regulatory body [1]. Approval by EMA takes place by using a centralized procedure. This leads to approval of the product in all 28 European Union (EU) Member States and in Iceland, Liechtenstein and Norway. At a country level, if approval in a single EU Member State only is required, this can take place using the national procedure. However, as soon as a company seeks approval in two or more Member States, a decentralized procedure or mutual recognition procedure must be used [2].

Bevacizumab is a humanized monoclonal antibody (mAb) targeting vascular endothelial growth factor (VEGF), which causes excessive growth of new blood vessels from pre-existing ones in the form of angiogenesis, underlying pathology of cancers and intraocular neovascular diseases. Through binding to soluble VEGF, bevacizumab sterically blocks the interaction of VEGF with VEGF receptor 2 on endothelial cells and thereby interrupts the activation of downstream signalling for angiogenesis. Bevacizumab is indicated for the treatment of a range of cancers, including metastatic colorectal cancer, metastatic breast cancer and non-small-cell lung cancer. It is also used for off-label treatment of eye diseases including neovascular age-related macular degeneration and diabetic macular oedema.

Canada’s drug regulator, Health Canada, has approved the adalimumab biosimilars Simlandi (AVT02) and Yuflyma (CT-P17).

The European Medicines Agency (EMA) is the body responsible for approval of biosimilars within the European Union (EU). A legal framework for approving biosimilars was established in 2003. Approval of biosimilars is based on an abbreviated registration process, which allows biosimilars manufacturers to provide a reduced package of information compared to originator drugs, provided they can prove ‘similarity’ to the originator or reference drug.

Prestige BioPharma has partnered with Dr Reddy’s Laboratories (Dr Reddy’s) to commercialize their trastuzumab biosimilar, HD201, while MS Pharma has joined up with Formycon for the commercialization of its ranibizumab biosimilar, FYB201.