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FDA Approves Pfizer's Trastuzumab Biosimilar, Trazimera

(The Center for Biosimilars) Mar 11, 2019 - The FDA has approved Pfizer’s trastuzumab-qyyp (Trazimera), a biosimilar referencing Herceptin. "This is an important milestone in the [United States] which both adds to our growing portfolio of oncology treatments and has the potential to improve access to cancer care,” said Andy Schmeltz, global president of Pfizer Oncology, in a statement. “We are proud to be able to offer treatment options that can help address the diverse needs of patients.”

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Debu Tripathy, MD (Posted: March 12, 2019)

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We will be seeing many more biosimilars approved in the coming years. This term is applied to biological agents since they are not precise chemical structures and therefore cannot be called "identical". By the same token, they may not possess completely equivalent clinical activity and safety. Regulatory agencies do not require the same rigor of testing as a new indication for a biologic agent, but they do have to show "similar" composition, activity and safety. Typically, the clinical endpoint may not have to be as robust (for example statistically non-inferior response as opposed to progression-free survival in the advanced setting, and complete pathological response pre-operatively as opposed to disease-free survival in the early stage setting). Nevertheless, it is general accepted (by some but not all), that these are similar enough to be substituted for the brand name. It is estimated that in the US, this may result in 30-40% drops in prices - maybe not the dramatic effect we would like to see in cancer drug prices, but outside of the US, they might make the difference between large numbers of patients receiving biological drugs vs. not.

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