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.
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.
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 .
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 .
A systematic review of the evidence on automatic substitution of biological medicines  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.
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 .
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 . 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.
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.
Biological drugs are defined as products with active ingredients produced from a biological source, whereas a biotechnological product is developed from the isolation of a gene of interest and its cloning .
Biosimilars are biological products that are highly similar to their reference biologicals. Biosimilars are designed to have comparability with respect to quality, safety and efficacy compared to an already licensed reference biological. Most regulatory agencies, including the European Medicines Agency (EMA), do not require a full clinical dossier for a biosimilar. It is usually possible to carry out one clinical trial in one indication, with the option to extrapolate to other indications of the reference biological .