Shots:

• 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

Ref: Amgen | Image: Industry Week