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Only CKD and Jeil have high-dose Xeljanz generics approved

By Lee, Hye-Kyung | translator Kim, Jung-Ju

23.12.12 05:50:42

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Higher dosage formulations have lower performance, concerns over safety are also an issue…most companies focus on developing low-dose generics

May release the generic versions after after patent expiry in November 2025

 ▲Pfizer

Jeil Pharm received approval for its ‘Topazan Tab 10mg,’ a high-dose generic version of the rheumatoid arthritis treatment ‘Xeljanz (tofacitinib citrate).’

With the Ministry of Food and Drug Safety’s approval of Topazan Tab 10mg on November 11 in addition to the Topazan Tab 5mg that was approved on November 27, Jeil Pharm now owns both low- and high-dose generic versions of Xeljanz.

Following Boryung, which received approval for ‘Boryung Tofacitinib TAb 5mg (tofacitinib aspartate) as the first Xeljanz generic in August 2020, 58 generics have been approved to date, but Chong Kun Dang is the only company that received approval for both the 5mg and 10mg doses.

Reasons

Lee, Hye-Kyung(hgrace7@dailypharm.com)
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