Ensuring innovation and competition for biologics leads to more timely products for patients

FDA

13 June 2019 - Today, the FDA approved the agency’s 20th biosimilar product, Kanjinti (trastuzumab-anns), for the treatment of patients with certain types of breast or stomach cancer.

It is the fifth FDA-approved biosimilar to Herceptin (trastuzumab), a remarkable development in and of itself, since about four years ago, there were no biosimilars approved in the U.S.

In 2010, Congress authorised an abbreviated licensure pathway through the Biologics Price Competition and Innovation Act (BPCI Act) for biological products that are demonstrated to be biosimilar to, or interchangeable with, an FDA-licensed biological reference product. One of the goals of the BPCI Act was to create greater competition in the medical marketplace that would increase treatment options for patients and lead to less expensive alternatives. This is critical, since biologics, which are generally complicated, large molecule drugs, have become a mainstay of modern medicine, play a critical role in the treatment of serious illnesses, and often present the only effective treatment option for some patients. Indeed, biologics today account for about a third of new therapies approved by the FDA.

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Michael Wonder

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Michael Wonder

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Medicine , US , Market access , Biosimilar