EU Drug Agency OKs Rule On Biosimilar Antibodies

Law360, New York (November 19, 2010, 12:35 PM EST) -- The European Union’s drug oversight agency on Friday adopted a new guideline governing biosimilar antibody medicines used to treat cancer and autoimmune diseases, moving Europe closer to allowing pharmaceutical makers to produce new, potentially cheaper versions of the drugs.

The European Medicines Agency’s guideline for so-called similar biological medicinal products containing monoclonal antibodies will outline clinical and nonclinical requirements for drugs containing a certain type of antibody that may be similar to others already on the market, the agency said.

The guideline, the EMA said, would...
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