Picking up on a hot new trend in the drug development world, Chinese officials are putting the finishing touches to a new set of regulations to govern the development of biosimilars. The Financial Times quotes regulators saying that they're hammering out the details for follow-on biologics, looking for a mix of guidelines drawn from both the U.S. and Europe.
There isn't anything unusual about biosimilars in China. Regulators have approved several hundred such drugs, according to the Southern Medicine Economic Research Institute. But they've been subjected to the same rules that have governed all new chemical entities, while these new regulations are likely to key off of demands in the U.S. for late-stage studies that can demonstrate clear efficacy and safety of copycat biologics.
Quoting Deloitte figures, the FT notes that biosimilars and biologics make up about 10% of China's booming pharma market. But with a new generation of antibodies in the clinic, that figure is expected to continue to swell at an annual growth rate of 32%.
Chinese officials have been ramrodding through a number of new initiatives aimed at bolstering the drug R&D industry. And Big Pharma has responded eagerly, investing billions of dollars in new research activities in China even as their research activities in the West are capped or chopped down. Some large multinationals, meanwhile, have been diving into the biosimilars game, anxious to cash in on less-expensive therapies that will compete with some well-known blockbusters.
- here's the article from the Financial Times