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 remains a few steps ahead of the U.S. with regard to their biosimilar regulatory scheme. European regulators have already approved 13 biosimilars, including generic versions of human growth hormone, erythropoietin, and G-CSF. Now that the FDA has begun to evaluate how the U.S. biosimilar pathway shall function, it is highly likely that the November EMA guidelines could serve as a model for future U.S. biosimilar requirements. The details on the EMA guidelines are not yet known, but it has been revealed that clinical trials will be required to establish antibody biosimilarity. However, the EMA would not reveal whether the biosimilar antibody would also be interchangeable for the original, a distinction that is relevant in the U.S. regulatory scheme as well as in Europe.
Antibodies represent a substantial economic opportunity for generic manufacturers both in the U.S. and Europe, and generic companies are eager to enter the multibillion-dollar antibody market as the patents on key brand products expire. However, despite the economic incentive, production of biosimilar antibodies is significantly more difficult than conventional small molecule drugs. So far, the EMA has received requests for scientific advice on only six biosimilar antibodies. One such request is by Teva, which is already conducting clinical studies comparing its generic antibody to Roche's antibody drug Rituxan.
It is certain that FDA officials, drug companies, and patent practitioners will be paying close attention to the November guidelines put forth by the EMA, as they very well could serve as a template for future U.S. guidance on antibody biosimilarity. PatentDocs will report on the guidelines in detail when they are made public next month.
James DeGiulio has a doctorate in molecular biology and genetics from Northwestern University and is a graduate of Northwestern University School of Law. Dr. DeGiulio is a member of MBHB's 2010 associate class and he can be contacted at [email protected].
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