Europe’s drug regulator set out guidelines for copying some of the most expensive biotechnology medicines, giving companies such as Novartis AG and Teva Pharmaceutical Industries Ltd access to a $36.4 billion market.
The European Medicines Agency’s draft regulation, posted today on the agency’s website, aims to clarify how drugmakers can copy and sell so-called monoclonal antibodies after they lose patent protection. The document is open to public comments until May 31, the London-based agency said.
Three important monoclonal antibody treatments are slated to lose patent protection by 2015: Roche Holding AG’s Herceptin for cancer, Biogen Idec Inc and Elan Corp’s multiple sclerosis drug Tysabri and Remicade for rheumatoid arthritis, sold by Johnson & Johnson and Merck & Co together, the medicines had sales of more than $10 billion last year.
“Looking out five to ten years, I see this as a multi-billion-dollar opportunity,” said Jeff George, who heads Novartis’ generic-drug unit, Sandoz. Novartis is working on eight to 10 copies of biological drugs, he said.
Antibodies are part of the immune system, recognising and fighting infection and other foreign substances in the human body. Monoclonal antibodies are produced to closely resemble human ones.
New Biosimilars
Monoclonal antibody copies would be a new type of biosimilar, a copy of a medicine designed to mimic substances fond in the body such as hormones. Conventional generic drugs are copies of treatments for high blood pressure or pain, and often don’t resemble biological compounds. Biosimilars have been sold in Europe since 2005. Companies use genetically engineered cells to make biosimilars, and conventional generics are manufactured by chemical reactions in large vats.
“Monoclonal antibodies are currently still perceived by many to be a bigger challenge for biosimilar development” than drugs like generic epoetin, an anemia treatment, according to Elmar Kraus, an analyst at DZ Bank in Frankfurt.
