FDA Approves Herceptin Biosimilar Kanjinti for HER2-positive Breast Cancer

FDA Approves Herceptin Biosimilar Kanjinti for HER2-positive Breast Cancer
The U.S. Food and Drug Administration (FDA) has approved Amgen and Allergan’s Kanjinti (trastuzumab-anns), a biosimilar to Genentech'Herceptin (trastuzumab), for all indications of its reference product — including as a treatment for HER2-positive breast cancer, the companies announced. A biosimilar is a biological medical product that is nearly identical to an original treatment that's already on the market, but usually at a significantly lower price. A different company will manufacture a biosimilar after the original product’s patent expires, but must first get regulatory approval. The FDA approval means that people in the U.S. with HER2-positive breast cancer, or gastroesophageal junction adenocarcinoma, can now receive a potentially less expensive form of the HER2-targeting antibody with a similar safety and efficacy as the original product. "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," David M. Reese, MD, executive vice presid
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