Boehringer Ingelheim GmbH is planning to test a version of Roche Holding AG (ROG)’s top-selling drug Rituxan with a trial design that may speed the copy to market.
Boehringer is recruiting 306 patients to test its version of the treatment in rheumatoid arthritis, Asthika Goonewardene, a London-based analyst for Bloomberg Industries, said in a note to clients today. The study caters to both European Union and U.S. regulators by using medicine made in both regions and is designed to compress the stages of data-gathering needed for approval into a single trial, Goonewardene said.
Boehringer is muscling into a crowded field. Novartis AG (NOVN), Celltrion Inc. (068270), partners Samsung Electronics Co. (005930) and Quintiles Transnational Corp., and Teva Pharmaceutical Industries Ltd. (TEVA) with Lonza Group AG (LONN) are among the companies already working on a Rituxan copy. The streamlined design of the study may give Boehringer an advantage, Goonewardene said.
“This will significantly decrease the cost of development in the U.S.,” the analyst said in a telephone interview.
Boehringer declined to comment. According to documents posted on the website ClinicalTrials.gov, the study was announced in September and isn’t yet recruiting patients. The Ingelheim, Germany-based drugmaker said in the documents it’s aiming to finish the research by April 2015.
Roche is working on innovations to counter potential copies of Rituxan, including a subcutaneous administration approach and GA101, a new compound designed to be better than Rituxan, said Daniel Grotzky, a spokesman for the Basel, Switzerland-based company.
Rituxan, also know by its generic name rituximab, had 6 billion Swiss francs ($6.45 billion) in sales last year. Roche’s patents on the medicine expire in 2018 in the U.S. and earlier in Europe. Biogen Idec Inc. (BIIB) helps market the drug in the U.S. Roche rose 0.5 percent to 181.90 Swiss francs at 2:35 p.m. in Zurich.
Because Rituxan is a biological drug, made out of living cells, putting out a copy isn’t as simple as making a generic of a chemically based pill like Pfizer Inc. (PFE)’s Lipitor or Viagra. Under EU regulations and draft U.S. guidelines, companies that want to sell a copy of a biotech drug, a so-called biosimilar, will need to show that their version of Rituxan does the same thing as Roche’s.
Teva and Lonza helped show how complicated the process can be this week. The partners stopped their planned 544-patient, final-stage trial of a Rituxan copy to confer with regulators about the best way to design the trial program, Bloomberg Industries reported on Oct. 3.
Patients hadn’t been treated yet in the trial, Teva said in a statement late yesterday.
“Teva is firmly committed to the development of biosimilars,” the Petach Tikva, Israel-based company said in the statement. “However, given the changes in the regulatory and competitive environment, Teva (through its joint venture with Lonza) is evaluating the path forward for rituximab.”
Regulators might also allow Teva to run one study to meet both European Union and Food and Drug Administration requirements, BI said.
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