Biosimilars
Celltrion updates on Remsima and Yuflyma
South Korean biotechnology company Celltrion announced two new data sets on the subcutaneous formulation Remsima (infliximab) in a number of conditions in March 2022. This followed the February 2022 announcement that the high-concentration version of Celltrion’s autoimmune disease biosimilar Yuflyma (adalimumab) has received approval from the European Commission.
Phase III trial evidence used in approval of ranibizumab biosimilar Byooviz
Byooviz (SB11) is the first ranibizumab biosimilar approved by the US Food and Drug Administration (FDA) and European Medicines Agency (EMA) [1, 2].
Biocomparables approved in Mexico
In Mexico, biological products with expired patents are known as biocomparable biotechnology drugs (medicamentos biotecnológicos biocomparables). The regulatory body in charge of approving biocomparables is the Federal Committee for Protection from Sanitary Risks (Comisión Federal para la Protección contra Riesgos Sanitarios, COFEPRIS).
Trastuzumab biosimilar Kanjinti remains stable in polyolefin bags and elastomeric devices
A study of the trastuzumab biosimilar ABP 980 (Kanjinti) finds that the compound remains stable in concentrated multi-dose bags and diluted in intravenous (IV) bags and elastomeric devices, providing preparation options to suit different global pharmacy practices.
Henlius makes deal with Getz Pharma for adalimumab copy biological
China-based drugmaker Shanghai Henlius Biotech (Henlius) announced on 23 February 2022 that it had entered into a licensing and supply agreement with Pakistan-based Getz Pharma for its adalimumab copy biological, Handa Yuan (汉达远; HLX03).
Consortium of US hospitals to manufacture and sell biosimilar insulin
A consortium of large US hospitals, through the non-profit company Civica Rx, are to manufacture and sell biosimilar insulin capped at US$30 per vial.
Are systematic switch studies for biosimilars necessary?
A recently published review [1] questions the need for systematic switch studies to demonstrate the interchangeability of biosimilars, suggesting the studies are becoming obsolete.
Canada approves ranibizumab biosimilar Byooviz
The ranibizumab biosimilar Byooviz (SB11), produced by Samsung Bioepis and commercialized by Biogen, received approval from Canada’s drug regulator, Health Canada, on 8 March 2022. This is the first ranibizumab biosimilar to receive approval in Canada.
FDA accepts application for interchangeability of adalimumab biosimilar Abrilada
US-based pharma giant Pfizer announced on 25 February 2022 that the US Food and Drug Administration (FDA) had accepted for review the Prior Approval Supplement (PAS) to the Biologics License Application (BLA) for Abrilada (adalimumab-afzb) as an interchangeable biosimilar to Humira (adalimumab).
The CROWN study: real-world comparison between ‘similar biologic’ and originator ranibizumab and bevacizumab
The last decade and a half have witnessed a paradigm shift in the way vascular disorders affecting the retina are treated. Anti-vascular endothelial growth factor (VEGF) antibodies have become the mainstay of treatment. These monoclonal antibodies are injected in the vitreous cavity. For the treatment to be effective, repeated injections every 4 to 8 weeks over many years need to be given, which proves to be quite expensive.
