Results of a survey was carried out by the World Health Organization (WHO) revealed that challenges still remain when it comes to the regulatory evaluation of biosimilars .
The survey, which was carried out in 2019‒2020, covered most current topics pertinent to biosimilars. The results of the survey revealed that, despite the efforts of WHO in helping Member States implement the evaluation principles in the WHO biosimilar guidelines  into their regulatory practices, challenges still remain. These include interchangeability, naming and pharmacovigilance.
Interchangeability, naming and pharmacovigilance
Interchangeability continues to be a hot topic when it comes to biosimilars and many countries have different approaches. Approaches to this issue include automatic interchangeability upon approval, depending on the clinical evidence provided by the manufacturer and relying on decisions made by the prescriber.
In addition, the US Food and Drug Administration (FDA) has adopted a unique regulatory process whereby a biosimilar can be approved as interchangeable. However, despite guidelines being issued in May 2019 , interchangeability requirements are still unclear and no biosimilar has been approved as interchangeable by FDA to date . No other regulatory authority has adopted this regulatory approach. This approach is also in contrast to the European Union (EU), where decisions on the interchangeability or substitution of biosimilars and originator biologicals are not made by the European Medicines Agency (EMA), but at the national level .
The authors acknowledged that this is a contentious issue, especially among healthcare professionals, who often require more concrete information on the efficacy and safety of interchangeability. However, they believe that this is ‘more of an issue to be considered and decided by physicians and patients rather than a regulatory issue’.
The scientific concept underlying the development and licensing of biosimilars is not always well understood and this is where communication and the education of both physicians and patients is important. The role of regulatory authorities in this, according to the authors, ‘is to inform physicians and patients about the regulatory assessment and decision as a prerequisite for switching products on the market’.
The WHO’s official guidelines on the evaluation of biosimilars (referred to as similar biotherapeutic products or SBPs) were adopted by the Expert Committee on Biological Standardization (ECBS) in 2009 . The authors suggest that publication of a national Q&A document on biosimilars, similar to the WHO document, and public assessment reports on biosimilars could serve as potential tools for aiding communication on biosimilars. They also suggest that the template for Public Assessment Summary Information for Biosimilar (PASIB), which was released by the Biosimilars Working Group of the International Pharmaceutical Regulators Forum (IPRF) in 2016 ‘could be used by regulators worldwide’. This they say, ‘would contribute to enhanced transparency and increase the public's confidence to uptake biosimilars and promote their interchangeability’.
Finally, as discussed in the article on quality of biosimilars , an efficient and comprehensive pharmacovigilance system is necessary to ensure the efficacy and safety of biosimilars. Thus, good pharmacovigilance is also essential for establishing the safety and efficacy of interchangeability of biosimilars.
Accurate naming is necessary in order to identify products and carry out pharmacovigilance. Any confusion over naming could lead to prescription mix‐ups, unintentional switching, and questions on traceability. Naming of biosimilars therefore continues to be a contentious issue that has been extensively discussed but has still reached no consensus. WHO has previously suggested the use of a biological qualifier for naming biologicals consisting of a random alphabetic code, made up of four random consonants . However, not everyone agreed with their proposal; for example, the International Generic and Biosimilar medicines Association (IGBA) opposed the move, stating that ‘successful product identification and tracking using multiple identification components are already in force’ .
The authors therefore state that to avoid problems biosimilars ‘should be clearly identifiable by a unique brand name together with the International Nonproprietary Naming (INN), as stated in the WHO Biosimilar Guidelines. Provision of the lot number, which is an important part of production information, is also essential’.
Conflict of interest
The authors of the research paper  declared that there was no conflict of interest.
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Regulatory issues related to quality of biosimilars
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Regulatory challenges with biosimilars
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7. GaBI Online - Generics and Biosimilars Initiative. Regulatory issues related to quality of biosimilars [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2021 Feb 12]. Available from: www.gabionline.net/Biosimilars/Research/Regulatory-issues-related-to-quality-of-biosimilars
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