Perhaps you remember how biosimilars are similar drugs to biopharmaceuticals. Biosimilars employ biosimilar approval pathways. These pathways are necessary in order to allow the manufacturing of these versions of the original drug. The approval depends on the expiration date of the exclusivity.
FDA defines drug shortages as the time-limited situations resulting from the drug demand exceeding the drug supply. To qualify as such, the American Society of Health-System Pharmacists (ASHP) verifies the drug stock with the manufacturers. However, the state of being medically necessary does not
