Biosimilars:
The US Food and Drug Administration (FDA) has released new draft guidelines aimed at reducing the cost and time for biosimilar development. This shift is expected to significantly benefit Indian pharma companies which have invested heavily in biosimilar pipelines. A biosimilar is a biologic medication that is highly similar to an already approved biologic, known as the reference product. A biosimilar is not a generic drug; unlike generics, which are simple chemical copies, biosimilars are complex proteins made from living cells, highly similar but not identical to the original biologic.This can remove the requirement for comparative efficacy trials, saving USD20–25 million per project, and shorten development timelines from 5–7 years to 3–4 years.Both biosimilars and their reference biologics are made from living sources such as cells, tissues, microorganisms (bacteria or yeast), or combinations of natural materials like proteins and sugars.
