Prof. Ciana Flashcards
What is a biosimilar?
A biosimilar is a biological medicine highly similar to another already approved biological medicine (the ‘reference medicine’ or ‘originator’). Biosimilars are a new class of medicinal products.
Biosimilars are approved according to the same standards of pharmaceutical quality, safety and efficacy that apply to all biological medicines. Biosimilar and its reference medicine are different from the point of view of the production process. In the phases of the process, there are a lot of variables that could change, such as environmental parameters, pH, temperature and these changes will change the resulting product. They should provide evidence of the same clinical efficacy and safety. The European Medicines Agency (EMA) is responsible for evaluating the majority of applications to market biosimilars in the European Union (EU). A biosimilar is not regarded as a generic of a biological medicine. This is mostly because the natural variability and more complex manufacturing of biological medicines do not allow an exact replication of the molecular micro-heterogeneity. A chemical molecule is simple to produce, but a biological product is so difficult for the previous several reasons. In 2004, the European Medicines Agency has elaborated new directives regulating the biosimilar approval. The first three biosimilar approved in Europe have been: Growth hormone, Erythropoietin and Granulocyte-colony stimulating factor. Rituximab is an example of biosimilars. In conclusion, the features of a biosimilar medicine are:
• Highly similar to the reference medicine
• No clinically meaningful differences compared with the reference medicine
• Variability of biosimilar kept within strict limits
• Same strict standards of quality, safety and efficacy
To demonstrate the biosimilarity between the biosimilar and the reference product, the biosimilar undergoes quality studies, non-clinical studies about safety and efficacy and then clinical studies about safety and efficacy. The biosimilar must have a name that allow its identification.
Prescriptions of biosimilar are increasing, they have a lower price compared to biological medicines and so more people can have access to use these drugs.
describe the gene therapies already approved by regulatory agencies for the treatment of cancer
