Case Studies

Biosimilar Market Authorization in Malaysia 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 […]

A UK-based global CHC organization wanted to seek MA for a Fixed Dose Combination analgesic formulation. The product was sourced from a 3rd party CMO. Usually, the 3rd party sourcing is required when the in-house pipeline not able to support markets or when there is a local/regional business need for a client. For getting a