New CFDA guidelines could stem MNCs' pricing power

New China FDA guidelines for bioequivalence studies of generic drugs could eventually reduce multinational companies' price premiums on brand name drugs that compete with local generics, according to Goldman Sachs analyst Richard Yeh. That could prompt MNCs to shift their strategies in China toward patented drugs, Yeh wrote in a note.

The three guidelines, which incorporate some assessment criteria used in the U.S., define technical details addressing selection of reference drugs and the design and assessment of in vitro and human studies, according to Yeh. He wrote that the guidelines are likely to improve Chinese generics' quality, and expects more guidelines in the coming months that will address China's regulation of generics. ...