Biosimilars approvals by thirteen regulatory authorities: A cross-national comparison

Machado, Fernanda Lacerda da Silva; Cañás, Martín; Doubova, Svetlana V.; Urtasun, Martín A.; Marín, Gustavo H.; Osorio-de-Castro, Claudia Garcia Serpa; Albuquerque, Flavia Caixeta; Ribeiro, Tatiane Bonfim; Pont, Lisa; Crisóstomo Landeros, José; Roldán Saelzer, Juan; Sepúlveda Viveros, Dino; Acosta, Angela; Machado Beltrán, Manuel A.; Gordillo Alas, Lily Iracema; Orellana Tablas, Lourdes Abigail; Benko, Ria; Convertino, Irma; Bonaso, Marco; Tuccori, Marco; Kirchmayer, Ursula; Contreras Sánchez, Saúl E.; Rodríguez-Tanta, L. Yesenia; Gutierrez Aures, Ysabel; Lin, Boya; Alipour-Haris, Golnoosh; Eworuke, Efe; Lopes, Luciane Cruz

doi:10.1016/j.yrtph.2023.105485

Cited by 3 publications

(6 citation statements)

References 25 publications

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“…The result of the median biosimilar approval lag of 800 days in this study is also similar to that of a recent study in Malaysia, which found a median approval lag of 855 days for innovative medicines [31]. While it is recognized that the timing of approval of new drugs, including biosimilars often varies across countries and regions [5,9], any delay could limit timely patient access [7,32]. The observed lag in biosimilar approval in this study therefore suggests that patients may experience delayed access to new biosimilar treatments that have already been approved on the international market.…”

Section: Biosimilar Lagsupporting

confidence: 86%

“…Between August 2008 and August 2023, 18 INN biosimilars in 38 different brands were approved in Malaysia, with a median of two biosimilar brands per INN reference biological product. These ndings are generally consistent with those of other studies that examined biosimilar approvals around the world [9,41,42]. For example, according to an IQVIA market report [42], as of July 2023, the FDA had approved 40 biosimilar brands across 15 reference biologic products.…”

Section: Biosimilar Evolution In Malaysiasupporting

confidence: 84%

“…Using a time-to-event analysis of 18 INN biosimilars approved in the EU, it was found that subsequent approval occurred in Malaysia between August 2008 and August 2023, on average 800 days after EU approval. Previous studies have similarly reported approval time delays for biosimilars between countries and jurisdictions [9,29,30]. Though these studies focused only on approved biosimilars, which may have underestimated the time lag [6], their ndings on time lag are generally comparable to the current study.…”

Section: Biosimilar Lagsupporting

confidence: 68%

“…EU approval was used as the global reference because the Malaysia biosimilar guidelines were based on the EMA biosimilar guidelines. [11], and the EU is the global pioneer in biosimilar approval, with the most approvals and uptake in the world [3,9].…”

Section: Introductionmentioning

confidence: 99%

“…Although regulatory approval does not always imply market availability, it is a necessary condition for market entry in many countries. Therefore, the absence or delay in biosimilar approval in a country may result in a of affordable treatment alternatives to innovative biological products [9,10].…”

Section: Introductionmentioning

confidence: 99%

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Biosimilar drug lag and evolution in Malaysia: A retrospective analysis of regulatory approvals

Hoang,

Fatokun,

Farrukh

2024

Preprint

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The availability of biosimilars has the potential to increase patient access to affordable biological treatments. However, a delay in national regulatory approval after global approval remains a concern, potentially impeding timely patient access. This study assessed the drug lag for biosimilars approved in Malaysia relative to the European Union (EU) and examined the evolution of biosimilar approvals in Malaysia between 4 August 2008 and 31 August 2023. The median biosimilar approval lag in Malaysia was 800 days (95% CI 398.57-1201.43). Over the study period, 18 INN biosimilars in 38 different brands were approved in Malaysia, with a majority (76.3%) of brand approvals occurring between 2016 and 2023. The number of brand approvals ranged from one to four per INN biosimilar, with a median of 2 (IQR = 1–3). The median time lag between the first and second biosimilar brand approvals was 608 days (IQR = 266–866), while that between the second and third brand approvals was 119.50 days (IQR = 50.25–1442.25). There was a notable drug lag for biosimilar approvals in Malaysia, but recent years showed an increasing trend in biosimilar brand approvals. Streamlined regulatory processes are essential to enhancing biosimilar availability and accessibility in Malaysia.

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Section: Biosimilar Lagsupporting

confidence: 86%

Section: Biosimilar Evolution In Malaysiasupporting

confidence: 84%

Section: Biosimilar Lagsupporting

confidence: 68%

Section: Introductionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

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Biosimilar drug lag and evolution in Malaysia: A retrospective analysis of regulatory approvals

Hoang,

Fatokun,

Farrukh

2024

Preprint

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Evaluating biosimilars: safety, efficacy, and regulatory considerations in clinical studies

Liu,

Wang,

Wang

et al. 2024

Int J Clin Pharm

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Biosimilars in the Era of Artificial Intelligence—International Regulations and the Use in Oncological Treatments

Bas,

Duarte

2024

Pharmaceuticals

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This research is based on three fundamental aspects of successful biosimilar development in the challenging biopharmaceutical market. First, biosimilar regulations in eight selected countries: Japan, South Korea, the United States, Canada, Brazil, Argentina, Australia, and South Africa, represent the four continents. The regulatory aspects of the countries studied are analyzed, highlighting the challenges facing biosimilars, including their complex approval processes and the need for standardized regulatory guidelines. There is an inconsistency depending on whether the biosimilar is used in a developed or developing country. In the countries observed, biosimilars are considered excellent alternatives to patent-protected biological products for the treatment of chronic diseases. In the second aspect addressed, various analytical AI modeling methods (such as machine learning tools, reinforcement learning, supervised, unsupervised, and deep learning tools) were analyzed to observe patterns that lead to the prevalence of biosimilars used in cancer to model the behaviors of the most prominent active compounds with spectroscopy. Finally, an analysis of the use of active compounds of biosimilars used in cancer and approved by the FDA and EMA was proposed.

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Biosimilars approvals by thirteen regulatory authorities: A cross-national comparison

Cited by 3 publications

References 25 publications

Biosimilar drug lag and evolution in Malaysia: A retrospective analysis of regulatory approvals

Biosimilar drug lag and evolution in Malaysia: A retrospective analysis of regulatory approvals

Evaluating biosimilars: safety, efficacy, and regulatory considerations in clinical studies

Biosimilars in the Era of Artificial Intelligence—International Regulations and the Use in Oncological Treatments

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