The above comment, although sounds a bit harsh, was made recently by none other than Scott Gottlieb - the Food and Drug Administration Commissioner of the United States. He expressed his anguish while explaining the reasons for a delayed launch of several important biosimilar drugs.
We know, this new genre of drugs has a potential to be a quick game changer, significantly improving access to affordable biologic medicines for many patients. Unfortunately, much desired accelerated progress in this direction, got considerably retarded in the face of a strong headwind, craftily created by the innovator companies, as is widely believed. There are various ways of creating the same. However, the two major ones can be ascribed to:
- Getting caught in the labyrinth of complex patent challenge.
- General apprehensions of many doctors on the efficacy and safety of biosimilars as compared to reference drugs.
This is happening in major markets, including India, in varying degree, though. In this article, I shall deliberate on this issue, starting with the largest pharma market of the world and then focusing on India.…continue reading…
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