Barriers towards effective pharmacovigilance systems of biosimilars in rheumatology: A Latin American survey

Abstract

Purpose This review summarises the current status of regulatory guidelines for the approval of biosimilars in Latin America and highlights the main barriers to effective pharmacovigilance in this region. We also report results from a survey of Latin American rheumatologists assessing their understanding of prescribing biosimilars and the pharmacovigilance of these drugs. Methods We reviewed the current guidelines for the regulatory approval of biosimilars and barriers to effective pharmacovigilance in Latin American countries. Rheumatologists attending the II Pan‐American League of Rheumatology Associations PANLAR Review Course (Biosimilars update) in Lima, Peru were asked to complete a short survey to determine their knowledge of biosimilars. Results Many Latin American countries continue to lag behind Europe and the United States in establishing regulatory guidance and effective pharmacovigilance systems for biosimilars. Results from our survey also highlight a lack of awareness regarding the availability of biosimilars, their nomenclature, automatic substitution, and reporting adverse drug reactions because of these drugs. Conclusions The main barriers to effective pharmacovigilance in Latin America are the lack of consensus on the interchangeability of reference biologics and biosimilars, and the need for more suitably trained personnel to carry out effective postmarketing pharmacovigilance of biosimilars. Inconsistencies in biosimilar nomenclature make it difficult to adequately trace drugs and record adverse drug reactions associated with their use, creating a barrier to the global pharmacovigilance of biologics.

Clinical and Regulatory Concerns of Biosimilars: A Review of Literature

“…After screening for eligibility, we included 16 studies in the analysis ( Table 2 ) [ 21 , 22 , 23 , 24 , 25 , 26 , 27 , 28 , 29 , 30 , 31 , 32 , 33 , 34 , 35 , 36 ]. The included studies were from Europe, UK, United States, Australia, Asia, and Africa [ 21 , 22 , 23 , 24 , 25 , 26 , 27 , 28 , 29 , 30 , 31 , 32 , 33 , 34 , 35 , 36 ]. The targeted healthcare professionals were: clinicians, GPs, pharmacists, nurses, consultants, care managers, and specialists in clinical settings where biologics are more involved such as oncology, rheumatology, endocrinology, gastroenterology, dermatology, nephrology, and hematology.…”

Health technology assessment of biosimilars worldwide: a scoping review

“…The biosimilar approval pathways are similar in most countries when their goal is to prove biosimilarity [4,5]. However, different countries tend to have different regulations to decide substitution and interchangeability [1,[4][5][6][7][8].…”

“…Despite this, the use of biosimilars, the cost-savings achieved and their market share vary considerably between biosimilar drugs, therapeutic areas, countries and even within the same country [ 6 , 12 , 13 ]. Those differences can be linked to an overall lack of biosimilar familiarity worldwide accompanied by concerns about biosimilars efficacy, safety, immunogenicity, extrapolation, switching and interchangeability [ 8 , 14 – 16 ].…”

Intercambialidade e substituição de biossimilares: seria a avaliação de tecnologias em saúde (ATS) um instrumento para tomada de decisão?

“…Complexity of the molecule and manufacturing process (live cells); possible immunogenic alterations 3,4, 28,36 Absence of standardization in the necessary evidence for assessment of biosimilarity and interchangeability by regulatory agencies 3, 37,38 Absence of national guidelines on substitution/interchangeability 4,5, 7,10,11,26,39 , standardization of nomenclature and pharmacovigilance systems 3, 37,38 Insufficient evidence from controlled clinical trials and real-world data that support substitution/interchangeability 3,4, 24,38,40,41,42 Absence of educational programs for physicians and patients on biosimilars and their reliability 3,4, 39,41,43,44 Box 1…”