Biosimilars aren’t “new” drugs, but they are significantly changing the landscape of breastcancertreatment. A biosimilar is a copy of a prescription that’s been on the market for a while and has an expired patent. However, unlike generics, biosimilars are only as similar to the original branded drug as validation technologies can confirm. This means a rigorous FDA/EMA review prior to approval in a new indication.
Biosimilar drugs cost less than their branded counterparts. The number of biosimilars available in oncology is likely to increase rapidly, with the therapeutic focus shifting from supportive care (chemotherapy) to targeted, life-prolonging (i.e. mAbs). Herceptin® is a monoclonal antibody (trastuzumab) which has approval in early/advanced breast cancer as well as gastric cancer (where patients show an overexpression of HER2). Several biosimilar versions of trastuzumab are flooding the European/US market.
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