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Most developed nations require drug manufacturer to prove that their formulations are bioequivalent to their brand name counterparts. Bioequivalence does not mean generic drugs must be exactly the same as the brand name product, chemical differences may exist Hatch Waxman act, standardized procedures for recognition of generic drugs. Before a company can market a generic drug, it needs to file an abbreviated new drug application (ANDA) with the food and drug administration. These products cannot be entirely identical because of batch-to-batch variability and their biological nature, and they are subject to extra rules. FDA also recognizes drugs that use the same ingredients with different bioavailability and divides them into therapeutic equivalence groups. Each year, drug makers lose exclusivity for popular medicines, forcing them to constantly research and launch new drugs to stay afloat. The FDAs purpose is to promote international harmonization of technical and scientific standards for generic medicine development. According to precedence research, the global generic drugs market was worth $390.57 billion in 2020 and is projected to reach approximately $574.63 billion by 2030, attaining a compound annual growth rate (CAGR) of 5.59 percent between 2021 and 2030. Generic cost around 40 to 60 percent less, and you get the same strength, dosage and quality of medication. Generic drug approval review in Japan is conducted by the pharmaceuticals and medical devices agency (PMDA), which reviews the equivalence of the original drugs. The original drugs are given the reexamination period of 8 years at the time of approval. The applicant can apply for the generic drugs after the reexamination period of original drugs. To manufacture and market generic drugs, unlike the original drug, there is no need to conduct clinical trials to verify efficacy and safety of the active ingredients.