Over the past few years some of the most influential groups in biotech have been hammering away at the argument over biosimilars, effectively shaping discussions around the core notion that complex biologics can't be knocked off like the traditional small molecule. Unique and expensive studies would be needed to prove they work as advertised; interchangeable status at the pharmacy could be hard to obtain. Costs would remain high.
Now a group of Indian and Chinese companies have invested hundreds of millions of dollars into new facilities that could rock, if not help topple, that elaborately-built premise, which has been influencing the FDA as it slowly ramps up a new regulatory structure to deal with follow-ups. As Gardiner Harris reports in The New York Times, pioneers like Dr. Yusuf Hamied at Cipla say that they can copy a number of biologics and sell them for a third of their regular price. And that's just for starters.
"Once we recover our costs, our prices will fall further," he told The Times. "A lot further."
Some UN officials insist that the developing world will need to get these drugs--classic blockbuster biologics like Herceptin, Avastin, Rituxan and Enbrel--at a low cost before they can effectively fight cancer and other non-communicable diseases. And that's a big focus in countries like India and China, where pharma giants have been investing big bucks as they position themselves to reap the rewards found in emerging markets.
Provided these upstart developers can deliver as promised, without presenting a host of new safety issues in their wake, the FDA could find itself under siege to explain why biosimilars will arrive in the U.S. slowly, with price tags that are still substantial.
- read the article from The New York Times