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Guidelines for Biosimilar Antibodies in Europe Due in November

By Donald Zuhn, Kevin Noonan, Chris Singer, Sherri Oslick, and Jason Derry

By James DeGiulio -- As the Food and Drug Administration begins gathering information on how to implement the new biosimilar approval pathway of the Biologics Price Competition and Innovation Act (see "FDA Planning to Hold Public Hearings on Biosimilar Approval Pathway"), the European Medicines Agency (EMA) announced that it has finalized its requirements for biosimilar antibodies, and that these requirements will be made public in November. Once the guidelines are released, they will be open to external consultation for three to six months before being formally adopted, and will likely go into effect in the second half of 2011. Europe...

Full post as published by Patent Docs on October 05, 2010 (boomark / email).