FDA OKs Fifth Biosimilar to Trastuzumab

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.

For more on this approval, visit Specialty Pharmacy Times®.