Biosimilars
Biosimilars approved in Colombia
In Colombia, the regulatory body for the approval of biologicals is the National Food and Drug Surveillance Institute (Instituto Nacional de Vigilancia de Medicamentos y Alimentos, INVIMA).
Real-world utilization of adalimumab biosimilar ABP 501
In a poster presentation at the virtual Crohn’s & Colitis Congress, which took place on 20‒22 January 2022, a study describing real-world utilization of adalimumab biosimilar ABP 501 in patients with inflammatory bowel disease (IBD) in Europe was presented [1].
Lupin forms partnership to market pegfilgrastim biosimilar in Brazil
Indian multinational pharmaceutical company Lupin Ltd (Lupin) has signed an agreement with Brazilian firm Biomm SA to distribute and market a pegfilgrastim biosimilar in Brazil. In related news, Indian firm Gland Pharma has announced plans to enter the market for biosimilar manufacturing.
Applications for adalimumab and trastuzumab biosimilars submitted to FDA
Korea-based Samsung Bioepis and partner US-based Organon announced on 5 January 2022 that the US Food and Drug Administration (FDA) had accepted the application for their proposed citrate-free, high-concentration (100 mg/mL) adalimumab biosimilar (SB5). A low-concentration formulation of SB5, Hadlima (adalimumab-bwwd), was approved in the US in July 2019 [1].
The impact of insulin biosimilars on the diabetes landscape
The cost of diabetes care in the US continues to rise, with insulin accessibility and affordability a particular concern for providers and patients. Increased competition from increased availability of insulin biosimilars may help address these issues.
Northwest Territories, Canada announces biosimilars switching policy
The Northwest Territories (NWT) has become the fifth jurisdiction in Canada to implement a biosimilars switching policy. The policy begins from 21 December 2021 and includes 10 biologicals.
FDA approves adalimumab and insulin glargine biosimilars Yusimry and Rezvoglar
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].
Differences in immunogenicity, pharmacovigilance and legal documents in biological products in Latin America
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].
Biosimilars approved in Ecuador
In Ecuador, the regulatory body for the approval of biologicals is the National Agency for Regulation, Control and Health Surveillance (ARCSA).
Biological standardization of bevacizumab: impact on global harmonization of potency assessment
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.
