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FDA Releases Draft Guidelines For Biosimilar Approval Pathway

Northeastern University Provides Input on Regulatory Standards

The FDA recently released draft guidelines for the Biosimilar Approval Pathway, which will accelerate the approval process for biosimilars—the generic versions of biopharmaceuticals. These guidelines will give drug companies who are producing these generic drugs the opportunity to enter the market rapidly.

Since 2009 Northeastern University has been working with the FDA and the biotechnology industry to give input on regulatory standards for approval of these next generation drugs.

Rather than just treating diseases such as cancer, biopharmaceuticals (though expensive) have the potential to cure these deadly conditions. The generic versions, biosimilars, may make these drugs available at lower price points.

These guidelines are designed to ensure the generic product is highly similar to the biopharmaceutical, and that there are no clinically meaningful differences between the two drugs.

Rituxan, manufactured by Genentech and Biogen Idec, is a biopharmaceutical used to treat certain types of Non-Hodgkin’s Lymphoma, Chronic Lymphocytic Leukemia and Rheumatoid Arthritis. The drug generates more than $6 billion is sales annually, and is expected to come of patent in 2015 here in the U.S. Currently, there are several biogeneic versions of this drug in clinical development. All drug developers looking to tap into Rituxan’s market will have to pass the biosimilar guidelines first.

The approval process for biosimilars is complicated because these drugs derive from living cells. This typically leads to a complex manufacturing process, high production costs and very stringent approval criteria.

With $50 billion worth of drug patents expected to expire in the next few years, officials have identified a need to shorten the approval method for biosimilars—putting them on the market faster, and creating more competitive, and eventually more affordable, versions of biopharmaceuticals. “There is enormous global interest in the biopharmaceutical sector and traditional pharmaceutical companies are increasing their presence and market share through investments, mergers and acquisitions of smaller biotechnology companies,” said Prof. Graham Jones, Chair of the Department of Chemistry and Chemical Biology at Northeastern University. “The innovative drugs in development, and generic versions thereof, now represents the fastest growing component of the drug industry.”

Jones and several other faculty members in the Barnett Institute and Department of Chemistry and Chemical Biology at Northeastern University have spent the past several years working with biotechnology companies to develop comprehensive and information rich approaches to characterize these new drugs. These methods include mass spectrometry and chromatography. “To compare a biosimilar with the innovator product, you must dive deep into the chemical structure of the biopharmaceutical, which is a fundamental strength of the Barnett Institute. Because of our expertise in this area, there will be many opportunities for us to play a significant role in the rapidly growing field of biosimilars,” said Dr. Barry Karger, director of the Barnett Institute.

Just recently, Northeastern faculty members visited the FDA campus to deliver training on biopharmaceutical analysis for members of their regulatory teams. “Our Barnett Institute researchers are world leaders in this field, and their work represents an exemplary model of use inspired research applied to the betterment of the healthcare industry,” said Jones.

Founded in 1898, Northeastern is a global, experiential, research university located in Boston. Northeastern is the recognized leader in experiential learning, anchored in the world’s largest and most innovative cooperative-education program. We integrate study with opportunities for professional work, research, and service in the United States and 82 other countries. The University’s use-inspired research enterprise is strategically aligned with three global imperatives: health, security, and sustainability. Northeastern offers a comprehensive range of undergraduate and graduate programs leading to degrees through the doctorate in eight colleges and the School of Law.

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