Biological standardization of bevacizumab: impact on global harmonization of potency assessment

Biosimilars/Research | Posted 21/01/2022

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.

Real-world data cannot replace post-approval confirmatory trials

Biosimilars/Research | Posted 21/01/2022

A study published in JAMA Network Open [1] finds that real-world data are not sufficient to confirm the benefits of drugs approved by the US Food and Drug Administration’s (FDA) accelerated approval programme, and therefore cannot replace post-approval confirmatory trials.

Differences in clinical studies and pharmacovigilance of biological drugs in Latin America

Biosimilars/Research | Posted 14/01/2022

Clinical studies are trials conducted in humans to test the efficacy of new drugs, devices, and other forms of treatment, as well as those already approved. On the other hand, preclinical or non-clinical studies are in vitro or in vivo studies, carried out on animals, which are necessary to evaluate the toxicity of the product and prove drug safety.

Regulations of the registration of biosimilars in Latin America

Biosimilars/Research | Posted 17/12/2021

In the review and comparison of biosimilar products performed in the nine Latin American countries, particularities were found regarding their definition, as some regulations do not include the term, affecting the biosimilarity exercise and clinical and non-clinical information. In addition, differences were also found in aspects of their use, such as extrapolation of indications and automatic substitution or interchangeability. As for its labelling, further research by health authorities is required [1].

Biosimilar uptake and the education of healthcare provider

Biosimilars/Research | Posted 17/12/2021

Affordability and access. Two simple words that nevertheless convey the complex burdens facing many healthcare systems around the world. And within the healthcare realm, there is likely no aspect that embodies issues related to affordability and access more than prescription medicines.

Biosimilar reimbursement rules cost Medicare over US$1.5 billion

Biosimilars/Research | Posted 10/12/2021

Current Medicare Part B biosimilar reimbursement rules prevented healthcare savings of over US$1.5 billion between 2015 and 2019, revealed a study published in JAMA Network Open [1].

Definition of biological terms in Latin America

Biosimilars/Research | Posted 03/12/2021

To conduct a comparative study of the health registration regulations for biological and biotechnological drugs in Latin America, Ramírez-Telles et al. made an approximation, as clear as possible, of biological terms: regulatory authority of reference, biotechnological drug, reference biological drug and innovative product. Its objective was to detect the differences and what these variations entailed when comparing the following Latin American countries: Brazil, Chile, Costa Rica, Cuba, Dominican Republic, El Salvador, Guatemala, Honduras and Panama [1]. 

Evidence on automatic substitution of biologicals is limited

Biosimilars/Research | Posted 03/12/2021

A systematic review of the evidence on automatic substitution of biological medicines [1] finds that current research evidence is mainly based on opinion polls and surveys of low-to-moderate quality, with results that are not generalizable or suitable for guiding policy.

Biosimilar mAb development – quality similarity considerations

Biosimilars/Research | Posted 26/11/2021

Since 2013, when the first biosimilar monoclonal antibody (mAb) was approved by the European Medicines Agency (EMA), the number of approved biosimilar mAbs has been increasing dramatically [1]. The large number of approved biosimilar mAbs in both the European Union (EU) and the US makes the evaluation of these applications possible from a product quality perspective.

Advances for Samsung Bioepis’ eculizumab and trastuzumab biosimilars

Biosimilars/Research | Posted 26/11/2021

Samsung Bioepis has announced the completion of its global phase III clinical trials of a biosimilar of Soliris (eculizumab), for treating certain rare blood diseases. In addition, it also presented its results from a five-year follow-up study that showed its biosimilar Ontruzant (trastuzumab) has comparable cardiac safety profiles and long-term efficacy as the originator, Herceptin.