Sweeping China Policy Reforms Seen Bolstering Domestic Generics
Off-patent original drugs in China are set to face unprecedented competition as the country drives up policy support for high-quality, bioequivalent domestic generics, and outlines other sweeping moves covering pricing and compulsory licenses.
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Offering deep price discounts in exchange for inclusion in reimbursement lists is never easy, given companies' need to balance expected benefits in volume gains with their international pricing systems and commercial pressures. But in China the underlying considerations are even more complex, as shown by the latest round of national price reductions for selected drugs.
All eyes on a list of selected oral hepatitis C drugs that are expected to win out in China's notoriously lengthy approval battle, amid a potentially huge opening as Chinese HCV patients switch from interferon to all oral therapies.
When a roomful of attendees at the annual ChinaTrials meeting, held Nov. 4 in Beijing, voted that a planned marketing authorization holder (MAH) system would be the single development likely to have the most impact on the pharma industry, few predicted that the scheme would come true just hours later.