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China approves first ambrisentan generic Posted 26/10/2018

China’s drug regulator, the China Food and Drug Administration (CFDA, 国家食品药品监督管理局 in simplified Chinese), has approved its first ambrisentan generic.

China-based Hansoh Pharma announced that it had received approval for sales of its generic ambrisentan product, Punuoan, in July 2018 as the first-to-market.

The drug is a generic version of GlaxoSmithKline’s endothelin receptor antagonist (ERA) Volibris (ambrisentan). Volibris is indicated for the treatment of pulmonary hypertension, which is a type of high blood pressure that affects the arteries in the lungs and the right side of the heart.

Volibris is designated as an orphan drug, which means that it was developed for use against a rare, life-threatening or chronically debilitating condition.

According to Chinese data collection service DXY Insight, ambrisentan is also being developed by 15 other Chinese companies. Four of these companies, including Chiatai Tianqing and Huahai Pharmaceutical, are waiting for approval of their applications.

China has been trying to improve access to medicines, speed up its drug approval process and cut healthcare costs, as part of a wide-ranging 2016‒2030 ‘healthy China’ plan aimed at raising life expectancy [1]. As part of this the CFDA will be merged into an overarching market supervision administration – the State Market Regulatory Administration (SMRA), with a new State Drug Administration (SDA) being established for the regulation of the life sciences and health care [2], under the supervision of the SMRA. In April 2018, the country also introduced a new policy of tax breaks for generics, as well as forbidding doctors to write brand names on prescriptions [1].

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References
1. GaBI Online - Generics and Biosimilars Initiative. China introduces new policy to boost generics [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2018 Oct 26]. Available from: www.gabionline.net/Policies-Legislation/China-introduces-new-policy-to-boost-generics
2. GaBI Online - Generics and Biosimilars Initiative. CFDA to come under national market supervision administration [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2018 Oct 26]. Available from: www.gabionline.net/Policies-Legislation/CFDA-to-come-under-national-market-supervision-administration

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Source: DXY Insight, Hansoh Pharma

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