Abstract
PurposeThis 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.MethodsWe 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.ResultsMany 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.ConclusionsThe 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.
Highlights
None of the rheumatologists reported the use (Biosimilars update), in Lima, Peru (September 6‐8, 2017).a,b Note: aThe survey was originally written in Spanish. bRemsima and Inflectra are the product names for the infliximab biosimilar, CT‐P13, developed by Celltrion (Incheon, Republic of Korea) and marketed worldwide.[70]
In Latin America, healthcare professionals play an important role in the pharmacovigilance of biologics, including biosimilars; they face several challenges
Key barriers to effective pharmacovigilance include the lack of international consensus on nomenclature to distinguish between reference biologics, biosimilars, and noncomparable biotherapeutics and the absence of clear guidance on interchangeability and substitution of a reference product with a biosimilar.[18,71]
Summary
As patent portfolios for reference biologics near end of term, pharmaceutical companies are developing safe and effective biosimilars for these drugs.[1,2,3,4] A biosimilar is highly similar to an approved reference product, with no clinically meaningful differences in purity, potency, and safety (Table 1).[5,6,7,8,9,10] Biosimilars can potentially increase patient access to more affordable biologic treatments and have an important role in the treatment of chronic conditions, including rheumatic and musculoskeletal diseases.[11,12] Several biosimilars are approved for treating patients with rheumatic and musculoskeletal diseases such as rheumatoid arthritis, ankylosing spondylitis, idiopathic juvenile arthritis, psoriatic arthritis, and other immune‐mediated inflammatory conditions.[2,13] In addition, several potential biosimilars are in development.As with reference biologics, biosimilars can cause an immunogenic response in treated individuals. The immune system can induce the development of antidrug antibodies in response to a biologic, which can impact the medicine's clinical efficacy and increase the risk of adverse drug reactions (ADRs).[14] Adverse events (AEs) such as cardiotoxicity, cytokine‐release syndrome, and reactivation of latent tuberculosis can be encountered with biologic treatments.[15] To ensure patient safety, it is important to monitor immunogenicity and ADRs during drug development and through postmarketing surveillance to gain real‐world clinical
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