An Update on the Registration of Biosimilars in Malaysia

Khoo, Yvonne Siew Khoon; Tang, Tien Yew; Goh, Pick Sim; Halimi, Hazureen Mohd; Ghani, Azizah Ab

doi:10.1177/2168479016664774

Cited by 3 publications

(2 citation statements)

References 2 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…Priority review with a target of 120 days may be granted for rst INN biosimilars that has not been previously registered in Malaysia [24]. However, these targets may be shorter or longer in practice depending on various time-dependent factors [15,19]. It can therefore be assumed that the biosimilar time lag observed in this study is attributed to both submission and regulatory review delays.…”

Section: Biosimilar Lagmentioning

confidence: 99%

“…However, it is unclear how quickly biosimilar approvals have occurred in Malaysia relative to the global situation and how approvals have evolved over the years. Previous studies have focused on the regulatory framework and processes [11,15,16], and stakeholder perceptions of biosimilars in Malaysia [17,18], with little attention to approval dynamics. Therefore, the objectives of this study were to assess the drug lag for biosimilars approved in Malaysia from their approval in the European Union (EU) and to examine the evolution of biosimilar approvals in Malaysia in terms of the number and approval time lag between successive brands of each biosimilar between 4 August 2008 and 31 August 2023.…”

Section: Introductionmentioning

confidence: 99%

See 1 more Smart Citation

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

Hoang,

Fatokun,

Farrukh

2024

Preprint

View full text Add to dashboard Cite

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.

show abstract

Section: Biosimilar Lagmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

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

Hoang,

Fatokun,

Farrukh

2024

Preprint

View full text Add to dashboard Cite

show abstract

Regulatory considerations in biosimilars: Asia pacific regions

Rathore

Bhargava

2020

Preparative Biochemistry & Biotechnology

View full text Add to dashboard Cite

Perspectives toward biosimilars among oncologists: A Malaysian survey

Chong

Rajah

Chow

et al. 2022

J Oncol Pharm Pract

View full text Add to dashboard Cite

Introduction Biosimilars confer significant cost-saving advantages and expand patients’ access to biologic therapies in cancer care. In line with the increasing availability of antineoplastic biosimilars, it is pertinent to understand the oncologists’ view on the adoption of biosimilars in their clinical practice. The study aimed to assess (i) the prevalence of biosimilar use, (ii) perception towards biosimilars, (iii) factors influencing the use of biosimilars and (iv) knowledge about biosimilars among Malaysian oncologists. Methods A cross-sectional survey was conducted among clinical oncologists and medical oncologists in Malaysia between January 2020 and February 2021 using a structured 31-item questionnaire. Results Among the 121 oncologists registered in the country, 36 responded (response rate = 30%). A total of 64% of the respondents prescribed biosimilars either often or always. Most oncologists (72%) agreed or strongly agreed that switching will not have a significant effect on the treatment benefit, with lower percentages saying that they agreed or strongly agreed that it will not lead to the emergence of additional adverse effects (56%) or harmful immunogenicity (64%). Patients’ preferences (40%) and the non-availability of biosimilars in hospitals (34%) are the major barriers cited to the prescribing of biosimilars. Cost differences and robust pharmacovigilance activities are the two most important factors that would influence the prescribing of biosimilars. The mean score of knowledge in biosimilar among respondents was 3.81 (± 0.86) out of a maximum possible score of 6. Conclusions The identified gap in prescribing and the use of biosimilars among Malaysian oncologists warrant educational intervention and robust pharmacovigilance activities to facilitate the prescribing of biosimilars and ultimately increase the accessibility to biologics in cancer treatment.

show abstract

An Update on the Registration of Biosimilars in Malaysia

Abstract: Study findings revealed some similarities and differences in current evaluation practice (timeline and requirements) for biosimilar versus novel BTPs. The findings of this research also provide an insight on current evaluation practice on biosimilar product labeling.

Cited by 3 publications

References 2 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

Regulatory considerations in biosimilars: Asia pacific regions

Perspectives toward biosimilars among oncologists: A Malaysian survey

Contact Info

Product

Resources

About