METHODS: This research aims to compare evaluation practice on biosimilar and novel BTPs at the Biological Product Registration Section in Malaysia. Evaluation activities were studied in terms of evaluation questions, evaluation timeline, nonclinical and clinical requirements, and local requirements on product label (including package insert). Six biosimilar product dossiers and 6 novel BTP dossiers evaluated in 2013-2015 were sampled. Parameters for comparison were determined and analyzed using data collection forms. Specific to the biosimilar products, the evaluation practice on labels and package inserts were dissected and described in a qualitative arm of this research.
RESULTS: Generally, the registration requirements of novel BTPs and biosimilar products are in agreement with international regulatory practices. However, some labeling and package insert requirements, and registration conditions are unique to the Malaysian regulatory context.
CONCLUSIONS: 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.
METHODS: The authors invited 48 CGTP companies to participate in the survey between October 2019 and June 2020, and 30 companies responded.
RESULTS: The majority of respondents were aware of the mandatory CGTP regulatory control and the availability of the guidelines. Many CGTPs were in the early development phase, and the most difficult registration barriers were dossier preparation and compliance with the pre-clinical and clinical requirements.
CONCLUSIONS: These findings represent the current CGTP landscape in Malaysia from the industry's viewpoint, enabling the NPRA to implement initiatives to facilitate registration and enforcement.