Additional Guidance in Brazil Is Necessary
The guidance released by ANVISA allows for the agency to have flexibility in determining requirements for biologics and biosimilars on a case-by-case basis. Further guidance is anticipated surrounding specific classes of medications, such as interferons and monoclonal antibodies, to provide individualized requirements for products of a complex nature. As such, it is important for ANVISA to consider releasing direction surrounding the regulation of NBCDs. NBCDs are complex products similar to biologics, but are produced via chemical synthesis, rather than live proteins.
In a recent article published in BioProcess International, Dr. Vera Weinstein notes, “NBCDs are medicinal non-biological products where the active substance is not a homo-molecular structure, but consists of a variety of different, closely related, structures which cannot be fully characterized.”5 Oftentimes these products lack a defined mechanism of action (MOA), and pharmacokinetic (PK) or pharmacodynamics (PD) testing is not sufficient to predict clinical outcomes. Due to the inability to characterize these products, significant issues related to the immunogenicity of these medications can arise. One such example of an NBCD is Copaxone®, a treatment indicated for relapsing-remitting multiple sclerosis (RRMS). It is currently impossible to identify the active sequences or epitopes in Copaxone®, even using the most technologically sophisticated separation techniques. Furthermore, the MOA and its specific effects on the immune system for Copaxone® are still not fully elucidated.6
NBCDs such as Copaxone® were a focus for a recent meeting held in São Paulo, Brazil, “U.S. & Brazil: Navigating New Frontiers in Pharmaceutical, Medical Device & Food Law & Regulation,” which brought together regulatory and industry experts to discuss food, medical device, and pharmaceutical regulations in the U.S. and Brazil. A panel discussion highlighted the need for additional regulations surrounding NBCDs to ensure products of this nature that are brought to market have proven safety and efficacy profiles.