Biosimilar medical products – licensing, pharmacovigilance and interchangeability

Abstract

The use of biological medicine has significantly increased in recent decades and has made substantial contributions to improving the effectiveness of therapies in many diseases. The expiration of patents of biological innovative medicines enables copies of those drugs called similar biological products (biosimilars) to be approved by regulatory authorities and to enter in clinical use. Biosimilars are comparable but not identical and are not a generic version of the innovator biological product. Although biosimilars undergo rigorous characterization as well as clinical studies to prove their safety and effectiveness, specific regulatory requirements for registration apply in the case of biosimilars. They are highly complex molecules and small changes in the production process can have major implications in its safety and effectiveness profile. The availability of biosimilars enhances competition, with the potential to improve patient access to biological medicines and to contribute to the financial sustainability of healthcare systems. In order to be certain that a biosimilar reaches its potential in clinical use, an intensive pharmacovigilance monitoring system must be established in order to prove the true similarity between the original biologic and its biosimilar. There is a need for further guidance and resolution of the ongoing discussions on biosimilar labelling, naming, pharmacovigilance and substitution in order to ensure effective and appropriate use of biosimilars in clinical practice.

Regulatory considerations of biosimilars and clinical dilema of their use

“…But, since biosimilar drugs are not exact copies and the generic approach cannot be applied in this case, the discussion whether they can be substitutes of original biologics is still open. Interchangeability and substitution of biosimilars is not regulated buy any EU regulatory document and EMA does not have the authority to designate a biosimilar as automatically substitutable, so it is left to each member country to decide how this process is going to be defined (23). European Consensus document released by the European Commission notes that interchangeability implies an initiative or agreement by the prescriber, patients and pharmacist about switching decisions and changing therapy from one biologic product to another (24).…”

Clinical Outcomes and Patient Experience of Biosimilar to Biosimilar Infliximab Switching in Patients with Inflammatory Bowel Disease: A Prospective, Single-Centre, Phase IV Interventional Study with a Nested Qualitative Study

“…The expiry of the patents on a num-ber of these drugs has allowed the development of biosimilar molecules with significant reductions in drug acquisition costs. With the growing number of available biosimilars, clinical studies in real-world patient populations are required to inform decisions made by physicians at a local level about transitioning between biosimilars and the safety of doing so [1,2]. The majority of the current literature compares biosimilars of infliximab to their originator [3][4][5][6][7][8].…”

Custo-minimização da troca entre o medicamento referência seu biossimilar: sustentabilidade na relação tratamento vs. saúde suplementar

“…Como disposto na Resolução da Diretoria Colegiada (RDC) nº 55, de 16 de dezembro de 2010, da Agência Nacional de Vigilância Sanitária (ANVISA), órgão vinculado ao Ministério da Saúde (MS) que tem por objetivo regular e controlar a área sanitária de serviços e produtos em todo o território brasileiro, é considerado um produto biológico o medicamento biológico não novo ou conhecido, que contém molécula com atividade biológica conhecida, já registrado no Brasil, e que tenha passado por todas as etapas de fabricação propostas. Tratam-se de produtos altamente complexos tanto no seu modo de produção quanto na sua estrutura molecular 2 , e o desempenho clínico pode não ser totalmente definido apenas através de meios físico-químicos como ocorre com as drogas sintéticas simples 3,4 .…”