Safety Issues of Biosimilar Products
Journal Title: Advances in Clinical Toxicology - Year 2019, Vol 4, Issue 3
Abstract
Biosimilars are not expected to be direct copies of biologic medicines and are therefore not the same as generic drugs. Due to the complex structure of biologic medicines and the processes involved in production, biosimilars must be shown on the basis of analytical, non-clinical and clinical data to be similar to an original biologic in terms of structural characteristics, and safety and efficacy. Minor differences with the active ingredient are expected and permitted so long as any such differences are demonstrated not to be clinically meaningful. In 2012, 7% of worldwide sales (US $53 billion) were at risk as a result of the free entry of generic drugs, which compete directly with the original brands, forcing them to lower their prices or, even worse, to stop producing them. By 2020, it is expected that this loss of profitability will reach US $259 billion. This is clear that biosimilars impose some goods in terms of availability and affordability but surely a discourage to invention of newer biotech products in future.
Authors and Affiliations
Mohiuddin AK*
Keywords
Related Articles
- EP ID EP751661
- DOI 10.23880/act-16000158
- Views 1
- Downloads 0
Polytene Chromosomes as a Genotoxicology Tool
It is not possible to visualize the interphase chromosomes with light microscopy; however, polytene chromosomes are giant interphase chromosomes visible under light microscopy. Therefore, polytene chromosomes of Dros...
Chronic Toxicity in Wistar Rats of Cytoreg, An Ionic Antineoplastic Therapeutic Mix of Strong and Weak Acids
Drugs are used for prevention, diagnosis and treatment of diseases of humans or other living things. The efficacy and safety of new drugs must be shown in order for the compounds to become marketable. In the research an...
Hepatoprotective Activity of Hydroalcoholic Extract of Murraya Koeinigii Leaves against CCl4-Induced Hepatotoxicity in Rats
The objective of the present study was to evaluate hepatoprotective activity of hydroalcoholic extract of Murraya koenigii leaves (HAMK) in rats. Hepatic damage was induced by administration of carbontetra chloride (1 m...
Metformin Improves Dopamine Release and Motor Performance in C57BL/6N Mice induced by MPTP: Insights of Alternative Medication for Parkinson’s Disease
It is obvious that Levodopa can effectively ameliorate most of the motor symptoms associated with Parkinson’s disease. However, Levodopa-induced dyskinesia (LID) experienced due to its long-term usage poses a great conc...
Risk Assessment of Dietary Exposure to Aflatoxin Contamination in Spices
This study highlights the daily consumption of spices in human diet and the potential of aflatoxin B1 (AFBI) contamination which attributable to the risk of developing liver cancer. All the AFBI contamination data in sp...