April 11, 2011 09:08 ET

Approval of Biosimilar Monoclonal Antibodies Faces Tough Regulatory Environment

ROCKVILLE, MD--(Marketwire - Apr 11, 2011) - has announced the addition of GBI Research's new report "Biosimilars Approval Pathways in the US and Europe," to their collection of Biopharmaceuticals market reports. For more information, visit

GBI Research analysis finds that reduction of healthcare expenditures is on top of the agenda for governments and so initiatives on introducing regulations governing biosimilars seems to be of prime importance in developing nations. Since biologics are among the highest priced therapies in the world, controlling expenses due to high priced biologics is one of the key focus points and it has increased the expectations of a regulatory pathway among the biosimilars industry participants.

Biologics Price Competition and Innovation Act (BPCIA), signed into law by US President Barack Obama in March 2010, establishes a regulatory pathway for approval of biosimilars in the US. The act empowers the FDA to develop standards to evaluate and approve biosimilars in the US. The act also grants FDA the authority to develop comprehensive guidelines for approval of biosimilar products or product classes. The act grants a market exclusivity of 12 years and data exclusivity of four years to innovator biologic drugs. Market exclusivity of 12 years is considered to be favorable to the innovator biologics.

The act also puts forward a resolution process for biosimilar related patent disputes. The process of patent resolution is very complex and is not very favorable to the biosimilar manufacturers. This patent resolution process is being considered as a major hurdle to the growth of biosimilars in the U.S.

GBI Research finds that one of the main challenges facing the biosimilars market is the intrinsic difficulty in replicating the efficacy profile of the original product. Biosimilars have similar therapeutic properties but they are not the same and hence the issue of interchangeability is a major hurdle for the rapid growth of the biosimilars market. Unlike generic versions of chemical drugs, biosimilars require preclinical and clinical studies to evaluate and comparison of efficacy and safety, if the biosimilars manufacturer claims interchangeability.

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