FDA Approves Fifth Trastuzumab Biosimilar


The approval of Amgen’s trastuzumab-anns, the fifth biosimilar to Herceptin, marks the twentieth biosimilar approved by the FDA.

Officials with the FDA approved Amgen’s trastuzumab-anns, also known as ABP 980 (Kanjinti), the fifth FDA-approved biosimilar referencing trastuzumab (Herceptin).

Trastuzumab is indicated for the treatment of human epidermal growth factor receptor 2 (HER2) overexpressing breast cancer and HER2 overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma.

This approval marks the twentieth biosimilar to be approved by the FDA for 9 different reference products since 2015, including at least 1 biosimilar approved for Avastin, Enbrel, Epogen/Procrit, Herceptin, Humira, Neulasta, Neupogen, Remicade, and Rituxan.

In FDA Voices, Janet Woodcock, MD, director of the Center of Drug Evaluation and Research for the FDA and Peter Marks, MD, PhD, director of the Center for Biologics, Evaluation and Research, provided their perspectives on the evolution of the US biosimilar market.

“Increasing competition in the market for biological products faces obstacles, such as current payment systems, litigation, and rebating practices,” Woodcock wrote. “A robust market for safe, effective biosimilar products is crucial—more products on the market increases competition, which can lead to more access and reduced health care costs for patients and our nation’s health care system.”

According to Woodcock, biologics represent approximately 40% of all prescription drug spending and account for 70% of spending growth from 2010 to 2015. The biosimilar market will play a critical role in countering this trend, she noted.

The latest approval is based on results from the phase 3 LILAC study, which was initially presented in 2017. The trial included 725 patients with HER2-positive early breast cancer who were randomized to receive either the biosimilar or the reference trastuzumab. After 4 cycles of chemotherapy, patients received a neoadjuvant course of their assigned therapy along with paclitaxel for 4 cycles.

According to the study, the primary pathologic complete response endpoint was achieved in 48% of those who received the biosimilar trastuzumab-anns versus 40.5% of those who received the reference product. By local review, the advantage for the biosimilar exceeded the prespecified 13% margin for bioequivalence by risk difference, but prespecified margins were not exceeded in the central review.

“By facilitating innovation that leads to more approved products, we can promote more competition within classes of biological products,” Marks wrote in FDA Voices. “This can offer different therapeutic options for patients, which can drive innovation to benefit patients and opportunities for price competition.”

ABP 980 was approved in the European Union in May 2018. Amgen previously received a Complete Response Letter from the FDA for the product in June 2018, according to The Center for Biosimilars.

“While the US market for biosimilars is still maturing, we welcome the opportunity to briefly reflect on the success that our 20th biosimilar represents,” Marks wrote. “We also know there is much more work to be done toward building the robust competitive environment we envision for biosimilars.”


  • Woodcock J, Marks P. Ensuring Innovation and Competition for Biologics Leads to More Timely Products for Patients. FDA Voices. https://bit.ly/2F8ny17. Accessed June 13, 2019.
  • Von Minckwitz G, Colleoni M, Kolberg HC, et al. Efficacy and safety of ABP 980 compared with reference trastuzumab in women with HER2-positive early breast cancer (LILAC study): a randomized, double-blind, phase 3 trial. Lancet Oncology. 2018. doi: 10.1016/S1470-2045(18)30241-9.

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