New York: Dr. Reddy’s Laboratories Ltd, India’s third-biggest drug maker, said its version of Roche Holding AG’s rituximab will be 50% cheaper than the original, allowing more access to the cancer therapy. Rituximab treats non-Hodgkin’s lymphoma, a blood malignancy. Reddy’s released Reditux on the weekend in Hyderabad, where the company is based. The generic-drug maker will also seek to sell the treatment elsewhere, including the US, spokeswoman Mythili Mamidanna said.
Reddy’s and bigger rivals Ranbaxy Laboratories Ltd and Cipla Ltd built billion-dollar businesses copying blockbuster medicines and selling them at a fraction of the price in the US and Europe. They are developing the capability to produce complex drugs, known as biologics, whose sales are growing at 14 times the pace of traditional chemical compounds and are among the most expensive prescriptions.
“The door is wide open”, for Indian companies to produce biologic medicines, said Sarah E. Frew, a research associate at the University of Toronto’s McLaughlin-Rotman Centre for Global Health. “We’re going to see more of this.”
Rituximab, approved to help fight non-Hodgkin’s lymphoma in the US almost a decade ago, generated more than $2 billion (Rs8,200 crore) last year. US companies Genentech Inc. and Biogen Idec Inc. market the drug as Rituxan in the US, and Basel, Switzerland-based Roche sells it in Europe under the name Mabthera.
Reddy’s Reditux is priced at Rs10,000 ($243) for a 100mg dose in a 10ml vial, or about half the price Roche charges for Mabthera, Dr. Reddy’s Mamidanna said. A 500mg dose will cost Rs40,000, she added.
The injectable medicine is a monoclonal antibody designed by scientists to target a particular type of cell.
Reditux is the second product from Dr. Reddy’s biologics unit, which is developing treatments for cancer and autoimmune diseases.
Reddy’s sells Grafeel, or filgrastim, to boost white blood-cell production. Filgrastim is marketed by Amgen Inc., based in Thousand Oaks, California, as Neupogen.
India has an estimated 40,000 sufferers of non-Hodgkin’s lymphoma, a type of cancer arising in white blood cells, said Mamidanna. Mabthera is patent-protected until 2013 and there are no immediate plans to change its price, said Roche spokeswoman Martina Rupp.
US law allows the Food & Drug Administration (FDA) to approve generic versions of conventional drugs, mostly made from chemical synthesis, after their patents expire. Congress is considering a law that would create a process to allow the FDA to approve generic versions of biotech medicines, sometimes known as “biosimilars”. Dr. Reddy’s plans to sell Reditux in other markets including the US, the world’s biggest drug market, Mamidanna said. “There is nothing actively being done about it at the moment.” The Indian drug maker doesn’t expect charges of infringement of patent by Roche in Indian courts, she said.
Clinical trials generally aren’t required for copies of conventional drugs, though for Reddy’s to gain approval for its version of rituximab, it would have to undergo years of testing that’s required for any new medicine.
Conventional drugs are small molecules that generic makers can reproduce in versions that are almost identical to the original product, and vary little from batch to batch. Biotech medications use living cells to produce human proteins, and the final composition can vary, depending on the techniques used.
Biotech companies say it is unlikely generic makers can easily reproduce the drug-making methods.
“New manufacturers would have to start again from scratch and would have to develop their own unique data to be able to be sure that the end product is not toxic and works in patients in the same way as the originator product,” Roche’s Rupp said in an emailed response to questions.
“The production needs the right production facilities and expert know-how,” she said. “Over the last 30 years, Roche has developed these molecules, learning about them very slowly.”