Improving the understanding of originator and biosimilar biologics among healthcare providers in Saudi Arabia

Omair, Mohammed A.; Alhawassi, Tariq M.; Alwaihibi, Munira; Aldrees, Ghada; Mosli, Mahmoud; Asser, Wesam M.; Alharaibi, Maryam Ali; Alotaibi, Atheer Tariq; Bintaleb, Doaa A.; Alharbi, Najah K.; Alotaibi, Ahmed Zabin; Alshammari, Wajed A.; Alanazi, Nouf; Asiri, Ali Mohammed; Almadany, Rana; Rayes, Hanan Al; Althunian, Turki A.; Alotaibi, Moureq R.; Jazaeri, Abdulrazaq Al

doi:10.1016/j.jsps.2020.11.008

Cited by 7 publications

(8 citation statements)

References 12 publications

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“…The SSR will aim to update these recommendations in parallel to future updates by the ACR. Future efforts should address questions related to the use of biosimilar [ 24 , 25 ], an important issue to rheumatology practice in the KSA not covered in the source guidelines.…”

Section: Discussionmentioning

confidence: 99%

Recommendations for the treatment of rheumatoid arthritis in Saudi Arabia: adolopment of the 2021 American College of Rheumatology guidelines

et al. 2022

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Background The 2021 American College of Rheumatology (ACR) rheumatoid arthritis (RA) guideline considers the specific context of the United States which differs from that of Saudi Arabia in many aspects that may impact recommendations. The objective of this project was to adapt a set of prioritized recommendations from the 2021 ACR guideline for the treatment of rheumatoid arthritis RA for the context of Saudi Arabia, by the Saudi Society for Rheumatology (SSR). Methods The process followed the GRADE-ADOLOPMENT methodology, and the reporting adhered to the RIGHT-Ad@pt checklist. Working groups included a coordination group and a 19-member panel representing different stakeholder groups. The Evidence to Decision (EtD) tables included evidence on health effects from the source guideline and contextual information from the Saudi setting. Results The panel prioritized and adapted five recommendations from the source guideline. The process led to modifying two out of the five prioritized recommendations, all listed here. In naive patients with low disease activity, methotrexate (MTX) is conditionally recommended over sulfasalazine (SSZ) (modified direction); hydroxychloroquine (HCQ) is conditionally recommended over SSZ (unmodified). Initiation of csDMARDs with short-term glucocorticoids is conditionally recommended over csDMARDs alone in naive patients with moderate to high disease activity (modified direction). Switch to subcutaneous MTX is conditionally recommended over addition/switch to alternative DMARD(s) in patients taking oral MTX who are not at target (unmodified). Discontinuation of MTX is conditionally recommended over gradual discontinuation of the bDMARD or tsDMARD for patients taking MTX plus a bDMARD or tsDMARD who wish to discontinue a DMARD (unmodified). Conclusion Rheumatologists practicing in Saudi Arabia can use the adoloped recommendations generated by this project while adopting the rest of the recommendations from the 2021 ACR guidelines.

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Section: Discussionmentioning

confidence: 99%

Recommendations for the treatment of rheumatoid arthritis in Saudi Arabia: adolopment of the 2021 American College of Rheumatology guidelines

et al. 2022

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“…We previously published a white paper describing a symposium that was presented in collaboration with three scientific societies (the SSR, the Saudi Pharmaceutical Society, and the Saudi Society of Clinical Pharmacy) on biosimilars. The white paper identified that the development of national guidelines on biosimilars use was the unmet need with the highest priority ( Omair et al, 2020 ). This is consistent with the barriers that were identified in our study.…”

Section: Discussionmentioning

confidence: 99%

Perception of Biosimilar Biologics and Non-Medical Prescription Switching among Rheumatologists: A Saudi Society for Rheumatology Initiative

Almadany

Omair

Rayes

et al. 2022

Saudi Pharmaceutical Journal

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Background The aim of this study was to evaluate rheumatologists’ perceptions of biosimilar biologics and Non-Medical Switching (NMS). Methods A cross-sectional survey was conducted among registered members of the Saudi Society for Rheumatology. The questionnaire focused on biosimilars and NMS. Logistic regression was performed to ascertain the effect of demographics and practice characteristics on the use of biosimilars and NMS. Results Out of 249 SSR members, 143 completed the survey, generating a response rate of 57.4%. Of those (59.44%) were men with a mean (±SD) age and years of practice of 42.3 ± 9.13 and 10.3 ± 8.9, respectively. Rheumatologists managing adult patients (81.82%) and Ministry of Health practice (43.36 %) were the majority of respondents. Previous experience in prescribing a biosimilar was reported by 43 (30.07%) participants, with a higher probability among women (p = 0.015). A total of 26 (18.18%) participants had performed NMS on eligible patients. Adequate knowledge on biosimilars was reported by 69 (48.25%) participants. The adequacy of evidence to grant biosimilar approval for the studied indication and extrapolation to treat other conditions was reported by 88 (61.5%) and 69 (48.3%), respectively. The concept of totality-of-the-evidence was well understood by 37.1%. Biosimilars had been previously used by 43 (30.07) participants in their practice. NMS had been attempted by 26 (18.18), while 86 (60.1%) participants believed that NMS might harm patients. Conclusion There is a clear knowledge gap about the biosimilar approval process among adult and pediatric rheumatologists who took part in the survey. In addition, a large number of participants reported having negative opinions about NMS. There is a need to organize SSR-led educational activities, and develop national guidelines regarding biosimilars and NMS.

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“…Given the evidence confirming the similarity of biosimilars to their respective reference products on the basis of rigorous pre-approval evaluations, regulatory agencies permit the extrapolation of the efficacy and safety of biosimilars from one approved indication to others for which the reference product has been approved based on a single, successful, phase III, randomized controlled trial [ 12 , 27 ]. Such extrapolation of indications may be approved even if the biosimilar has not been evaluated in the other indications if the reference product has the same mechanism of action in all of the other indications.…”

Section: Overarching Principles and Consensus Recommendationsmentioning

confidence: 99%

“…Biologics have intrinsic natural variability, which can result in variations between batches of the same product [ 73 ]. The regulatory approval of biosimilars differs from that of reference products, and although similar to each other, biosimilars can never be identical to reference products because of differences in the origin of the cell lines, as well as the complex manufacturing processes that may impact the translational and post-translation modifications and contaminants, biological activity, intrinsic heterogeneity, and stability [ 27 , 74 , 75 ]. Although comparability studies have demonstrated no differences in quality and impurities following a newer manufacturing process [ 72 , 76 ], regulatory bodies are concerned about the potential of biosimilars to induce an immunogenic response.…”

Section: Overarching Principles and Consensus Recommendationsmentioning

confidence: 99%

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Consensus-Based Overarching Principles and Recommendations on the Use of Biosimilars in the Treatment of Inflammatory Arthritis in the Gulf Region

Alnaqbi,

Al Adhoubi,

Aldallal

et al. 2024

BioDrugs

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Background Though biologic agents have significantly improved the treatment of inflammatory arthritis (rheumatoid arthritis, psoriatic arthritis, and axial spondyloarthritis), high costs, stringent regulations, strict reimbursement criteria, and existing patents have limited patient access to treatments. While being highly similar in quality, safety, and efficacy to biologic reference products, biosimilars can reduce the financial burden and prevent underutilization of medication. Objective The objective of this initiative was to develop an evidence-based consensus of overarching principles and recommendations aimed at standardizing the use of biosimilars in treating inflammatory arthritis in the Gulf region. Methods A task force of practicing rheumatologists, a clinical pharmacist, a health economist, patients, regulators, and payors from across the Gulf region developed recommendations and overarching principles based on the outputs of a systematic literature review conducted to address Patient-Intervention-Comparison-Outcome (PICO) questions specific to key challenges regarding the use of biosimilars for the treatment of inflammatory arthritis in the region. As the data before 2017 have been previously reviewed in another publication, the current review focused on data published between January 2017 and August 2022 (PROSPERO ID CRD42022364002). Consensus on each statement required a level of agreement of 70% or greater. Results Consensus was reached for five overarching principles and nine recommendations by the task force. The principles emphasize the importance of improving the awareness, understanding, and perception of biosimilars, as well as the need for regulated regional real-world data generation and protocols to make biosimilars a viable and affordable treatment option for all patients. The consensus recommendations advocate the need for shared treatment decisions between rheumatologists and patients when considering biosimilars. They further recommend that confirmation of a biosimilar’s efficacy and safety in a single indication is sufficient for extrapolation to other diseases for which the reference product has been approved. Finally, there is a need for pharmacovigilance and national health policies governing the adoption and prescription of biosimilars in clinical practice across the region. Conclusions These are the first consensus recommendations for the Gulf region based on a systematic literature review and Preferred Reporting Items for Systematic Review and Meta-analysis (PRISMA) guidelines, integrating clinical evidence with clinical expertise to optimize decision making for the use of biosimilars in patients with inflammatory arthritis. They were formulated based on predominantly international data because of the limited regional data and therefore can be generalized to serve as recommendations for healthcare professionals in other parts of the world. ...

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Improving the understanding of originator and biosimilar biologics among healthcare providers in Saudi Arabia

Cited by 7 publications

References 12 publications

Recommendations for the treatment of rheumatoid arthritis in Saudi Arabia: adolopment of the 2021 American College of Rheumatology guidelines

Recommendations for the treatment of rheumatoid arthritis in Saudi Arabia: adolopment of the 2021 American College of Rheumatology guidelines

Perception of Biosimilar Biologics and Non-Medical Prescription Switching among Rheumatologists: A Saudi Society for Rheumatology Initiative

Consensus-Based Overarching Principles and Recommendations on the Use of Biosimilars in the Treatment of Inflammatory Arthritis in the Gulf Region

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