The biosimilars era

In recent years, the development of new drugs that are more specific to a determined condition has led to an increase in their price. Because the whole process of creating a new treatment, involves so many years of research and trials to confirm not only their efficacy, but also that they don’t generate several adverse events, that’s why when they finally go to the market, they are sold very expensive.

Thanks to the plenty experience we have working with patients, we know that they usually don’t receive these novel treatments because they are highly expensive; besides the fact that they are not given in all public health centers.  However, right now it is known that the most expensive cancer treatments, which are for lung, breast and kidney metastatic cancer, for example, have a strong relationship with the large gains in life expectancy. Information given by the Epidemiology and end results (SEER)-Medicare database, where Howard et al., (2016) found it and reported it in his article “New Anticancer Drugs Associated With Large Increases In Costs And Life Expectancy”. Because those treatments are not available for everyone, there are some pharmaceutical companies that are focused on creating biosimilars. The biosimilars are produced according to specific requirements established by the European Medicines Agency (EMEA) to ensure their quality, efficacy and safety; which has been shown to be comparable to the original medicine, once the patent has expired.

Running clinical trials that are reliable is important to demonstrate that the investigational product has the same quality as the original one. In the whole process, we know how important is the correct selection of subjects, taking care about the conditions that the drug has to be stored in, and which documents are required for the approval from the involved Committees, among other requirements.  You can give us a call to know about the process and we will more than happy to assist you as soon as possible in order to run your next biosimilar trial.