Continuing the series on biosimilar medications, once the challenges of product development, analytical characterization and comparability, preclinical and the results of clinical studies have been overcome, we enter the phase of preparation and approval of the registration.
In order to guarantee success and obtain the registration of the biological medication, there is an important step, which is the elaboration of a good registration dossier. And for this to happen, it is essential to follow the following steps:
· Choose a qualified professional for the construction of the dossier, as it is necessary for him to be able to organize the information, checking the consistency of data and ensuring that the different parties talk to each other, since it is a sector of very specific knowledge where the ANVISA technician who will evaluate the record has very high qualification.
· In biologicals, the active principle is basically the product, so ANVISA's focus on the technical part of the dossier will be for this item, mainly for the construction of the lineage and the master cell bank, product characterization and the exercise of analytical comparability.
· The production part of both the active principle and the final product must be clearly stated, proving that the process is well established and controlled, showing the company's knowledge of the critical points of production and their respective controls.
· Quality control and stability need to guarantee constant product quality and rely on robust and validated methodologies.
· When presenting the results of the clinical research, a final report of well-organized efficacy and safety studies will facilitate ANVISA’s assessment and must include the result of immunogenicity studies that assess the body's immune response to the biological drug molecule.
· The pharmacovigilance plan, which is another key point in the approval of biosimilars, should also be included, describing how the product will be monitored on the market, how risk management will be carried out, and the actions for drug surveillance.
Today, the queue for the registration of biologicals has only 6 products, the oldest being filed in 10/2018; that is, the delay in registration is not a barrier in this case and even the technical complexity is already much clearer for the company that embarked on this path, because ANVISA is very open to discuss the steps with the companies, which undoubtedly increases the chance of success.
The great discussion of biosimilars is in interchangeability. But that will be one of the topics in another blog post.