Korean pharmaceutical companies are competing fiercely to develop the generic drugs of Trajenta Tab, the latest antidiabetic medication, industry sources said.
The review process of Trajenta will end in September, allowing the domestic makers to seek permissions for generic development. The medicine review system is designed to gather information to confirm the safety and efficacy of new drugs after approving them. Officials restrict the permission for the generics of new medicines during the period.
Trajenta was second most prescribed drug to treat diabetes last year with its prescription amount reaching112.8 billion won ($97.6 million) including complexes, according to UBIST, a market research agency. General practitioners have also welcomed the drug, as they can prescribe it relatively freely for patients with kidney
The domestic pharmaceutical companies have competed to submit applications for bioequivalence test to develop the generics of Trajenta as soon as its review period ends in September. The bioequivalence test aims to verify whether generics are equal to original drugs in efficacy and effect.
Regulators gave the go-ahead to 18 bioequivalence tests to develop the generic drugs of Trajenta and Trajenta-bio tabs last year, according to National Institute of Food and Drug Safety Evaluation under Ministry of Food and Drug Safety Monday.
Following Trajenta’s lead were Talion tab to treat allergic rhinitis with 15 approvals, and Brilinta tab to treat thrombotic cardiovascular diseases with 10 approvals.
Also active was the development of generics for Tamiflu, a flu-fighting drug the patent period of which expired in 2016. Regulators made eight approvals for its generic development last year.
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