UNE College of Pharmacy’s Edward Li testifies at FDA Advisory Committee on breast cancer treatment drug

Edward Li, Pharm.D., M.P.H., BCOP, professor in the College of Pharmacy, has testified at the Open Public Hearing portion of the July 13, 2017 Oncologic Drugs Advisory Committee. The committee discussed the biologics license application of a proposed biosimilar to Herceptin^® (trastuzumab), used to treat a form of breast cancer.

Biosimilars are a type of biological product that are licensed (approved) by the FDA because they are highly similar to an already FDA-approved biological product, known as the biological reference product. These approved biosimilars have been shown to have no clinically meaningful differences from the reference product and are also less expensive.

The proposed biosimilar to Herceptin^® would be used to treat HER2 positive breast cancer, an aggressive form of the disease. This treatment would function in the same manner as Herceptin^® but would be a lower-cost alternative. Approving this product will allow healthcare providers and patients another product option within HER2 positive breast cancer, and it will help to increase access to medications while reducing spending on drug therapy.  

“With the addition of new and impending immunoncology agents, there is an increase in the financial pressure on our healthcare system,” said Li. “We urgently need market competition to reduce overall spending on trastuzumab products, which will help to moderate the growth of oncology drug expenditures.” 

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