FDA Approves 17th Biosimilar, Third for Herceptin
The US Food and Drug Administration (FDA) on Friday approved Merck and Samsung Bioepis’ Ontruzant (trastuzumab-dttb), the third biosimilar approved in the US to Roche’s Herceptin (trastuzumab).In the US, where no Herceptin biosimilar has launched, there are two other competitors: Celltrion’s Herzuma (trastuzumab-pkrb), approved in December 2018, and Mylan and Biocon’s Ogivri (trastuzumab-dkst), approved in December 2017.
In Europe, Ontruzant launched in March and according to Bernstein Research, biosimilars there are now capturing 11% share of the reference product market. There are now four competitors for Herceptin in Europe: Celltrion’s Herzuma (trastuzumab), which launched in May 2018, Amgen’s Kanjinti, which Bernstein said started showing up as promotional product in June in Germany; and Pfizer’s Trazimera, which was approved in July.
Pfizer on Interchangeability
Meanwhile, as the US has yet to see its first interchangeable biosimilar, Pfizer’s Laura McKinley, John Kelton and Robert Popovian are clarifying interchangeability, as well as recent draft guidance from the US Food and Drug Administration (FDA) on interchangeability, and further discussing substitution and physician-mediated switching.
The authors explain that a designation of interchangeability, or lack thereof, “does not relate to the quality, safety or effectiveness of biosimilars or interchangeable biological products. Rather, this designation is intended to meet an additional statutory standard that would enable substitution at the pharmacy level without the intervention of the healthcare provider who prescribed the reference product.”
Building off a citizen petition filed by Pfizer on regulating biosimilar misinformation, they also highlighted how, “Despite FDA’s efforts, there continues to be a great deal of confusion and misinformation surrounding the topic of interchangeability.”