Last year, Roche appeared to throw in the towel on its breast cancer drug Herceptin in India when it said it would not defend the patent there. But it has come back out swinging with a court action that has messed with this week's launch of a biosimilar from Mylan.
Mylan said today that it and Indian biologics partner Biocon have nabbed the first approval in India and will have a biosimilar of Herceptin (trastuzumab) ready to roll out early next year.
A team from IBM Research and the Institute of Bioengineering and Nanotechnology in Singapore have designed a Vitamin E-based hydrogel that can release Roche's cancer antibody Herceptin under the skin for several weeks.
Roche's cancer drug Kadcyla, an expected superstar that is pegged to assume the mantle of Herceptin in later years, has moved forward in Europe where Friday it was recommended for approval. The FDA signed off on it February.
Now that the Swiss drugmaker has decided to forego a patent fight over the breast cancer drug in India, domestic drugmakers are rubbing their hands together in anticipation.
Roche could have Indian competition for Herceptin sooner than it thought. Now that the Swiss drugmaker has decided to forego a patent fight over the breast cancer drug in India, domestic drugmakers are rubbing their hands together in anticipation.
Roche is throwing in the towel on its IP protection for Herceptin in India. As PharmAsia News reports, the company will give up its patents for Herceptin there, a move that opens it up to biosimilar competition and potentially heads off compulsory licensing in the process.
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 Cranbury, NJ-based biotech says they will focus on knockoffs of Humira, Rituxan, Avastin, Herceptin and Erbitux.
The Kolkata Patent Office pulled divisional patents for the drug, saying they hadn't been properly submitted, Reuters reports. The news comes on the heels of GlaxoSmithKline's losing a key patent on another breast cancer drug, Tykerb.