In a meeting conducted last month, the FDA declared the regulation of biosimilar and interchangeable drugs with regards to Insulin. This has muddled the understanding of the working and processing criteria of the Pharmaceutical industry.
Apart from the transition in Insulin drugs, other biological products such as Human Growth Hormone is also taken into consideration to be given a biosimilar instance and announced deemed under the under section 351 of the Public Health Service Act (PHS Act). The changes can be seen taking place latest by March 2020. The FDA has also issued two drafts and two guidelines following a proposed rule that elaborates the expectations among the pharma industry, for the biosimilar drugs.