Unlike most small-molecule drugs, which are chemically synthesized with highly predictable structures and functions, biologics and biosimilars are pharmaceutical compounds synthesized or extracted from a biological source, often with much more complex structures. Thus, unlike generic medicines in which the active ingredients are identical to the reference small-molecule drug, biosimilars are approved by worldwide regulatory agencies based on the demonstration of a “high similarity” to the reference products. DDReg was tasked to register a biosimilar product sourced from a CMO in Malaysia for a customer who is among the top 10 pharma companies in India. This, if successful, was to be Ist biosimilar in the RoW market for the customer.

Ideally, this was routine or “just another” project for DDReg. However, this was not to be as the product was not simple generic, complex generic, or value-added generic. It was a biological product – a biosimilar. Since it was a biological product, the technology and development process was completely different from of routine generics. The documentation was very elaborate, complex and voluminous. On top of the regulations were not so well developed for Malaysia for biosimilars. Therefore, taking right regulatory decisions and living up to DDReg’s image and promise of delivering “First Time Right” was a tough challenge.

Solution:
The team was able to cover all aspects of development, manufacturing, pre-clinical & clinical testing and compile the submission dossier as well as application.

With the committed & focused effort of the working team that plugged almost all possible query generating avenues, the biosimilar submission had a successful review by NPRA Malaysia and was a granted market authorization. This leads to many successes for the customer as it was the first biosimilar MA grant for the customer in the ROW market. Customers enjoyed the first-mover advantage for the specific biosimilar in Malaysia. This success also opened business opportunities for the same product in other ASEAN markets.