PANLAR presented its position on biosimilar medicines at its own congress in Argentina. Via the consensus statement, the PANLAR specialists seek to demonstrate the efficacy, pharmacovigilance, regulation, quality and safety of biosimilar medicines.
PANLAR, the Pan American League of Associations for Rheumatology, is an association of Rheumatology professional bodies from 21 member nations of North, Central and South Americas.
PANLAR, founded in 1943, gathers the scientific societies of rheumatology, health professionals related to rheumatic illnesses and rheumatic patient associations of all countries in the Americas.
Considering the availability of biologicals, biosimilars and biomimics in North American and Latin American countries is evolving, with differing regulations and clinical indications, in 2019, PANLAR created a consensus statement on biosimilars in rheumatology.
The consensus statement was intended for a target audience of rheumatologists and healthcare providers, regulators, legislators and patients. The consensus process was developed by four groups: PANLAR steering committee, the scientific committee, panel members and an external panel review. A modified Delphi process, a group consensus strategy, in which participants’ answers are analysed anonymously, was chosen for development of the consensus statement.
The following topics as priorities were explored during the consensus process: regulation, efficacy and safety, extrapolation of indications, interchangeability, automatic substitution, pharmacovigilance, risk management, naming, traceability, registries, economic aspects and biomimics. Using a questionnaire in the process, consensus was achieved when there was agreement among 80% or more of panel members. A total of three Delphi rounds were completed.
The position of PANLAR regarding biosimilars, based on the consensus process, is presented below, see Table 1.
| Table 1: PANLAR position on biosimilars in rheumatology
|| PANLAR position
| General recommendation
|| 1. Biosimilars should be considered as a therapeutic option for RMDs.
2. A naming convention should be implemented to clearly identify and distinguish a specific biological (biosimilar or reference biological).
3. A risk management plan (RMP) should be required by regulatory agencies approving biosimilars. The RMP on biosimilars should be the same as for their reference products.
4. Strategies to ensure traceability should be implemented to follow all steps along the supply chain, allowing the association of adverse effects with a specific modification.
5. An effective pharmacovigilance programme should be implemented using activities to closely monitor, identify, and evaluate any safety issues related to biosimilars.
6. The implementation of registries is encouraged to facilitate post-approval surveillance of biosimilars to monitor safety.
| Public health and access
|| 7. The price of a biosimilar should be significantly lower than that of its reference product, thereby increasing access to these expensive medicines.
| Particular issues
|| 8. Biomimics (intended copies, unregulated biologicals, or similar biotherapeutic products) cannot be considered biosimilars unless they have been reviewed and approved by a regulatory agency according to the guidelines developed by WHO on the approval of biosimilars. As biomimics have not undergone this regulatory process, PANLAR does not recommend their use.
| RMDs: rheumatic and musculoskeletal diseases; WHO: World Health Organization.
No consensus was achieved regarding extrapolation of indications, and some regulatory agencies suggest that decisions should be made on an indication-by-indication basis. The panel members did not reach consensus about automatic substitution either.
Most panel members agreed that all biomimics should be required to demonstrate efficacy and safety in well-designed comparative effectiveness clinical trials and be subject to regulatory review according to the pathway for biosimilar approval recommended by WHO so that, if approved, they could be considered to be true biosimilars.
As there are not harmonized regulations regarding biosimilars in Latin America and North America, this work by PANLAR proposes consensus recommendations based on established international guidelines to be followed by various stakeholders caring for patients with rheumatologic diseases.
Dissemination of this consensus statement through educational programmes can help patients, healthcare professionals, and policy makers to better understand the development and use in clinical practice.
The results of this consensus statement should facilitate access to biological therapies for rheumatologic diseases by promoting the use of high-quality biosimilar medications at competitive prices.
Readers interested to learn more about policy recommendations of biosimilars in Europe are invited to visit www.gabi-journal.net to view the following manuscript published in GaBI Journal:
Policy recommendations for a sustainable biosimilars market: lessons from Europe
GaBI Journal is indexed in Embase, Scopus, Emerging Sources Citation Index and more.
Readers interested in contributing a research or perspective paper in Spanish and/or English on biosimilar policies in Latin America to GaBI Journal – an independent, peer reviewed academic journal – please submit your manuscript here.
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