- The Chinese FDA is granting priority review to four major pharmaceutical companies for their blockbuster antiviral hepatitis C treatments, potentially hastening the commercialization of the drugs in China, reports The Wall Street Journal.
- None of the new oral direct-acting anti-virals for treating hepatitis C (HCV) have so far been approved in China, so patients still must rely on interferon-based therapies. Regulatory review in China for new drugs can stretch for several years.
- In order to expedite approval of these new treatments, the Chinese FDA is will expedite regulatory review of hepatitis C drugs from Gilead, AbbVie, Bristol-Myers Squibb (BMS) and Xian Janssen, a joint venture involving Janssen.
The impetus for this change is a new policy adopted by the Chinese FDA in February, The Journal said. This policy is aimed at spurring innovation for various diseases, including hepatitis, AIDS, and tuberculosis.
According to IMS Health estimates, the Chinese drug market will be worth $185 billion by 2018, compared to $63 billion in 2014. In addition to a more valuable pharmaceutical market, healthcare spending is also projected to increase substantially. This large market has tempted international drugmakers but long approval timelines and other hurdles can stand in their way.
This is something that the Chinese State Council is attempting to change. Spurring innovation is part of a larger set of reforms, which include consolidation of the market, better quality oversight, and shorter approval timelines.
In order to qualify for expedited approval, companies must show that their treatments have significant advantages over existing treatment options. In addition, foreign companies pursuing expedited approval are strongly encouraged to manufacture in China, and simultaneously submit applications in the US and the EU, when submitting to the CFDA—with the goal of having uniform quality standards.
The World Health Organization (WHO) estimates that 10 million people in China have hepatitis C, indicating a significant unmet medical need. China's determination to expedite approval timelines for the new antivirals could help improve public health among that population.