Don't panic on Roche's behalf yet. Losing some Herceptin patent protections in India doesn't mean biosimilar versions will hit the market posthaste. That's partly for legal reasons--the company still retains the compound patent on the drug--but also for practical reasons. Domestic drugmakers aren't yet ready to sell them.
The first obstacle could be cleared soon, at least theoretically. Indian officials have been considering handing out compulsory licenses on several cancer drugs, including Herceptin, which would allow particular generics makers to sell their own versions, despite what patent coverage remains.
But as the Economic Times reports, the government is hesitating on a compulsory license for Herceptin. Officials want to find out a., whether any companies have actually applied for approval for their own biosimilar versions; and b., how long the approval process might take, should an application exist. Apparently, the applicable law on compulsory licenses requires "urgency" in supplying lower-cost alternatives--and if it takes too long for those alternatives to hit the market, then that throws the urgency argument into question.
"It is important for the government to first test the waters on whether there are companies ready to take the compulsory license and manufacture the drug," former Ranbaxy Laboratories president Ramesh Adige told the ET. "If a CL is issued and there are no takers, it would be embarrassing."
Cipla, which has been at the forefront of selling knockoff cancer drugs in India, including an unauthorized copy of Bayer's Nexavar, set up a biosimilars partnership in 2010, aiming to turn out a Herceptin substitute. But as of February, the World Health Organization believed that Indian companies--Cipla included--weren't ready to make biosimilar versions.
So, unless knockoff versions are more advanced than previously thought, the only lower-cost versions of Herceptin are likely to come from Roche's partner, Emcure Pharma, which is turning out the drug at a big discount.
Roche actually increased its price cut earlier this year, in fact, after India issued a compulsory license on Nexavar, but it's still too expensive for many Indians to afford. Some patient advocates figure that a compulsory license might spur development, but the timetable for biosimilars is much longer than for generic pills.
- read the ET article
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