Amgen, Allergan get FDA nod for biosimilar Herceptin
Amgen and Allergan have received the Food and Drug Administration’s green light for Kanjinti (trastuzumab-anns), a biosimilar of Genentech’s Herceptin (trastuzumab), for all approved indications: for the treatment of HER2-overexpressing adjuvant and metastatic breast cancer and HER2-overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma.
“The FDA approval of Kanjinti is an important milestone for our biosimilars portfolio, providing an additional treatment option for patients across three types of cancer,” David Reese, Amgen executive vice president of research and development said. “Kanjinti is the third biosimilar from our portfolio to receive FDA approval, highlighting our long-term commitment to providing patients with serious illnesses access to high-quality biological therapies.”
“Kanjinti is the second of four biosimilars from Amgen and Allergan’s collaboration to be approved by the FDA,” Allergan chief research and development officer David Nicholson said. “We are proud of the progress being made as we continuously strive to develop and deliver high-quality cancer therapies in collaboration with Amgen.”
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