Bio similars/Off Patent Generic Biologic drugs

A Billion Dollar Boost

The EU Regulators


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.


New Bio-similars
Monoclonal antibody copies would be a new type of bio similar, a copy of a medicine designed to mimic substances found 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. Bio similars have been sold in Europe since 2005. Companies use genetically engineered cells to make bio similars, and conventional generics are manufactured by chemical reactions in large vats. The guidelines released today establish the kinds of tests and studies needed to show the copy is similar to the branded drug. Companies will have to submit their products to human trials, though they will usually be less extensive than those needed for the approval of a branded antibody. The agency may accept trials that forgo the use of a control group, and compare the generic with the original. The regulator also may accept data gathered to support the application of a treatment in one illness to support approval for other uses.

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