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Yungjin applies for approval of its Ofev generic

By Hwang, Byung-woo | translator Kang, Shin-Kook

24.08.23 05:21:05

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First Korean company to confirm bioequivalence

Company owns technology for synthesizing nintedanib API and can produce the finished product in-house

Seeks to solely lead the development of a generic version of Boehringer Ingelheim¡¯s Ofev

 ¡ãPic of Boehringer Ingelheim

Yungjin Pharmaceutical announced on the 22nd that it has completed the license application for a generic version of Boehringer Ingelheim's ¡®Ofev Soft Cap (Ofev)¡¯ that it had developed by changing the original drug¡¯s soft capsule formulation into a tablet.

As a global blockbuster product, Ofev (nintedanib) is widely used in combination with pirfenidone to delay the decline in lung function in patients with idiopathic pulmonary fibrosis.

Despite being a non-reimbursed drug in Korea, Ofev generated sales of around KRW 6 billion last year and is in such high demand that a petition is underway for its reimbursement.

Yungjin Pharmaceutical was the first Korean pharmaceutica

Hwang, Byung-woo(tuai@dailypharm.com)
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