Welcome to this week's FiercePharmaAsia report, which includes China's new wave of policy changes aimed to streamline clinical trials and drug approvals, a special report on the top 15 generic drugmakers by 2016 revenue, a new biologics plant by Boehringer Ingelheim in Shanghai and more.
In a wave of drug policy proposals, China’s FDA is offering to grant conditional OKs for orphan meds already approved abroad, even without in-China trial data. The “conditional marketing authorization” idea was listed as part of CFDA’s expedited review program rolled out last February, but it was then targeted toward meds that treat life-threatening conditions and has shown preliminary clinical benefits.
In another proposal, CFDA is revamping clinical trial policies. To foster new trial sites, the agency is backing away from its certification system, which requires any facility that wants to conduct clinical trials to obtain a certificate first. It also plans to adopt the U.S. FDA’s approach and change its trial approval system to a “no response means approval” mechanism.
Emerging markets have been relying heavily on generics, and several Indian companies made our “top 15 generic drugmakers by 2016 revenue.” Sun Pharma (6), Lupin (9), Aurobindo (12), Dr. Reddy’s (13) and Cipla (14) are among the 15, although many of the Indian drugmakers faced increasing pricing pressure and regulatory setbacks.
Boehringer Ingelheim just opened a €70 million facility in Shanghai where it will do contract manufacturing. The first phase of that biologics plant can handle clinical supplies or commercial production up to 2,000 liters, while it is designed so that it can add additional 2,000L capabilities if demand calls for that. With that facility, the company expects to capitalize on China’s huge population and growing demand for meds.
Following a kickback probe in South Korea that saw Novartis handed a $50 million fine and have coverage on several meds suspended, the Swiss pharma said it's strengthening and simplifying its global ethics and compliance approach. It is aiming to shift from policing to coaching, with a compliance unit focused on helping local units make the right decisions.
Regulatory actions from the FDA has left a huge dent in Dr. Reddy’s Laboratories’ annual financials. In the last fiscal year, the company’s revenues in North America were down 16% to about $993 million. The Indian drugmaker acknowledged that the FDA’s problems with its manufacturing had a part in the gloomy performance, but also attribute the fall to increased competition to a key drug.