Amgen and Allergan’s Kanjinti (biosimilar, trastuzumab) Receive the US FDA’s Approval for All Approved Indications of Herceptin

Amgen and Allergan's Kanjinti (trastuzumab, biosimilar) Receive FDA’s Approval for All Approved Indications of Herceptin


  • The FDA’s approval is based on the totality of evidence which includes extensive comparative analytical, pharmacokinetic and clinical data demonstrating that Kanjinti is highly similar and have no clinical differences from Roche’s Herceptin
  • Kanjinti is the second biosimilar from Amgen and Allergan’s collaboration and third biosimilar from the Amgen’s portfolio to receive FDA’s approval for HER2-overexpressing adjuvant & m-breast cancer and HER2-overexpressing m-gastric or gastroesophageal junction adenocarcinoma
  • Kanjinti is an immunoglobulin G1 kappa mAb consisting same amino acid sequence, structure and function as trastuzumab and has same dosage form & strength following reconstitution as trastuzumab

Click here to read full press release/ article | Ref: Amgen | Image: Industry Week