Amgen and Allergan have secured approval from the US Food and Drug Administration (FDA) for Kanjinti (trastuzumab-anns), a biosimilar to Roche’s Herceptin (trastuzumab).
The FDA has approved Kanjinti for all approved indications of the reference product Herceptin to treat HER2-overexpressing adjuvant and metastatic breast cancer and HER2-overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma.
Trastuzumab is a recombinant DNA-derived humanised monoclonal immunoglobulin G1 kappa antibody. Kanjinti’ active ingredient is humanised monoclonal antibody, which has the same amino acid sequence, structure and function as trastuzumab.
Kanjinti holds the same pharmaceutical dosage form and same strength after reconstitution as trastuzumab, and is not yet commercialised.
Allergan chief research and development officer David Nicholson said: “KANJINTI is the second of four biosimilars from Amgen and Allergan’s collaboration to be approved by the FDA.
“We are proud of the progress being made as we continuously strive to develop and deliver high-quality cancer therapies in collaboration with Amgen.”
According to Amgen, Kanjinti was showed to be highly similar and have no clinically meaningful differences from Herceptin based on a comprehensive totality of evidence that included extensive comparative analytical, pharmacokinetic and clinical data.
Kanjinti is claimed to be the only trastuzumab biosimilar to integrate the evaluation of a single transition in the clinical study at the time of approval, showing similar safety and immunogenicity in patients who have been previously on Herceptin.
Amgen research and development executive vice president Dr David Reese said: “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.
“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.”
Amgen includes 10 biosimilars in its portfolio, of which three were approved in the US and three in the European Union (EU).
The biosimilar, in combination with cisplatin and capecitabine or 5-fluorouracil, is indicated to treat patients with HER2-overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma, who have not received prior treatment for metastatic disease.