Indian Drug Maker Cuts Cost of Cancer Therapy

PharmaManufacturing.com
05/03/2007

Dr. Reddy's Laboratories, India's third-biggest drug maker, said that its version of Roche Holding's cancer therapy, rituximab, would allow greater access at half the price of the original.

Rituximab treats non-Hodgkin's lymphoma, a blood malignancy. Reddy's released Reditux over the weekend in Hyderabad, India, where the company is based. The generic-drug maker will also seek to sell the treatment elsewhere, including the United States, a company spokeswoman, Mythili Mamidanna, said by telephone on Monday.

Reddy's and bigger rivals, Ranbaxy Laboratories and Cipla, have built billion-dollar businesses copying blockbuster medicines and selling them at a fraction of their usual price in the United States and Europe. They are developing the capability to produce complex drugs, known as biologics, which are among the most expensive prescription drugs and for which sales are growing at 14 times the pace of traditional chemical compounds.

"The door is wide open" for Indian companies to produce biologic drugs, said Sarah 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 in the U.S. almost a decade ago, generated more than $2 billion last year. U.S.-based Genentech and Biogen Idec market the drug as Rituxan in the United States, and Roche sells it in Europe under the name Mabthera.

Reddy's Reditux is priced at 20,000 rupees, or $486, for a vial, or about half the price that Roche charges for Mabthera, Mamidanna said.

The injectable medicine is a monoclonal antibody designed by scientists to target a particular type of cell.

Reditux is the second product from the 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 as Neupogen.

India has an estimated 40,000 people diagnosed with non-Hodgkin's lymphoma, a type of cancer arising in white blood cells, Mamidanna said.

Mabthera is patent-protected until 2013 and there are no immediate plans to change its price, said Martina Rupp, a Roche spokeswoman.

U.S. law allows the Food and Drug Administration 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."

Clinical trials generally are not required for copies of conventional drugs, though Reddy's would have to undergo the years of testing that is required of any new drug in order to gain approval for its version of rituximab.

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 that it is unlikely generic makers could 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.