Biopharmaceuticals are therapeutic protein based medications generated using genetically modified cells. With the advent of recombinant DNA technology and a long series of scientific advances, it is now possible to produce highly complex biological compounds in large scale. This enables the industry to give patients access to highly effective and specific biologics, important for the treatment of various serious conditions, such as cancer, autoimmune diseases and other disorders.
The establishment of a solid biotechnology platform combined with the application of the highest quality standards will allow Brazil to produce previously imported biologics locally, followed by the fully back-integrated development and manufacture of novel innovative biopharmaceuticals.
The creation of an innovative biopharmaceutical product requires a long period of research and development and a high investment. Translational research, which focuses on the transformation of knowledge generated by basic research into new therapies and medicines, has lead to quantum-leaps in medicine. Therapeutic monoclonal antibodies represent such progress and have revolutionized the treatment of autoimmune diseases, cancer and other serious conditions.
Developing a copy of an innovative biopharmaceutical is an extremely sophisticated process, demanding an average of eight years to complete. The development process comprises a series of systematic activities that require a large investment and significant technical training. These activities include items such as the generation of cells that will produce the drug, biopharmaceutical characterization, production process optimization and clinical research. In addition, the biological medicines, which are much larger molecules and much more complex than synthetic drugs, need to be fully analytically characterized. These are some of the reasons why the term “generic” does not apply to copies of biological medicines that are thus called biosimilars.
In the US and the European Community, the development of biosimilars is regulated strictly by the central regulatory agencies FDA and EMA. In Brazil the development of biosimilars is regulated by ANVISA to the highest ethical, technical and scientific standards, with criteria comparable to those adopted in Europe and USA. This allowed expansion of patient access to numerous biological medicinal products.