Domestic pharmaceuticals active to develop drugs by changing combinations or administration routes

Korean pharmaceutical companies are now actively developing incrementally modified drugs, officials said Tuesday.

The incrementally modified drugs refer to medicines that have similar compounds and efficacy to original drugs but have changed the properties and types of the latter to produce the effectiveness. A typical example is a complex drug that mixes two or more compounds.

The Ministry of Food and Drug Safety 식품의약품안전처 recognizes those products as incrementally modified drugs which are backed up by data proving they are better than original ones regarding safety, efficacy, and usefulness. The clinical trial periods of the incrementally modified drugs are shorter than those of new medicines, and investment costs are also smaller.

According to the ministry’s analysis of medicines approved in 2016, the number of approvals for incrementally modified drugs, which plunged from 19 in 2013 to one in 2014, rebounded to 18 in 2015 And to 24 last year.

Especially noticeable were the development of high blood pressure compound drugs and diabetics complex drugs. Among the newly approved drugs were Dukarb by Boryung Pharm보령제약, Karbpine by Boryung Biopharma보령바이오파마, Candeamlo by Shinpoong신풍제약, Machkhan by CJ HealthcareCJ헬스케어, Zemimet SR Tab. by LG ChemicalLG화학, and Duvimet XR Tab. by Chong Kun Dang종근당.

Some incrementally modified drugs have changed their administration routes. Liporaxel Sol. Developed by Daehwa pharmaceutical대화제약 turned the substance of paclitaxel for anticancer therapy into an oral anticancer drug for the first time in the world. GastiinCR made by Korea United Pharm한국유나이티드제약 and approved last year is an incrementally modified drug that changed a general drug to an extended release(ER) type. ER slowly melts in our body, which makes patients reduce the number of medication intake. Multinational pharmaceuticals have released ER medicines to increase market share.

Also approved by the ministry as incrementally modified drugs were Sayprep Sol., a colonic irrigation medicine developed by CTC Bio씨티씨바이오, Duocolon Sol. By Alvogen Korea알보젠코리아, and Coolipa Sol. By Ahngook Pharm안국약품 last year.

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