New Delhi, Oct. 31 -- The U.S. Food and Drug Administration (FDA) has announced major steps to make it faster and less costly to develop biosimilar medicines, lower-cost "generic" alternatives to biologic drugs used to treat serious and chronic diseases.
In a new draft guidance, the FDA has proposed major updates aimed at simplifying biosimilarity studies and reducing unnecessary clinical testing.
The agency also launched a separate initiative to make it easier for biosimilars to be developed as interchangeable with brand-name biologics, allowing patients and pharmacists to choose affordable options more easily.
It also noted that the expensive biologic drugs account for only 5 per cent of prescriptions in the U.S. but make up 51 per c...
		
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