An Update on the Registration of Biosimilars in Malaysia.

Background: Because of its structure and complex manufacturing process, every biotherapeutic product (BTP; medicinal products made by or derived from living organisms and produced by biotechnology) adheres to stringent quality assurance and control requirements, in addition to extensive nonclinical and clinical study data. Similarly, copy products of original biotherapeutics (termed as "biosimilars") are subjected to equally strict regulatory control. BTPs have been registered in Malaysia since the 1990s; however, registration of biosimilars started only in 2008.

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.