Amgen Enters Biosimilar Market With Launch Of KANJINTI™ For Breast Cancer And Other Tumors

Sao Paulo / PRNewswire / - Amgen, one of the world's leading biotechnology companies, launches its first biosimilar for cancer treatment in the Brazilian market. KANJINTI™^1,2 (trastuzumab) has been approved by ANVISA (National Health Surveillance Agency) after passing tests that have proven its biosimilarity to Herceptin®³ .

Targeted therapy is indicated for patients with the HE2-positive mutation who are undergoing treatment for early, metastatic breast cancer and advanced gastric cancer. "The arrival of KANJINTI™ in the Brazilian market is a milestone for Amgen, which aims to make affordable high cost biological therapies for patients with serious diseases, complementing our portfolio of cancer therapies and expanding treatment options in the country," says the director. Amgen's doctor in Brazil, Tatiana Castello Branco .

KANJINTI™ is the only biosimilar in the Brazilian market that has undergone a phase III clinical study in which the transition from the reference drug to the biosimilar with the maintenance of clinical results. The data show that the new drug has no relevant clinical differences from the reference drug, demonstrating its safety and corresponding immunogenicity in patients already using the originator molecule.

Biosimilars and Metastatic Breast Cancer

Breast cancer is the most common cancer among Brazilian women: 59,700 new breast cancer cases are estimated for each year in 2018-2019, with an estimated risk of 56.33 cases per 100,000 women⁴ . The TCU (Federal Audit Court) operational audit identified that the diagnosis of cancer in Brazil is made late. The arrival of biosimilars represents a real opportunity for Brazilian patients to access these technologies, especially in these advanced cases.

"Targeted therapy acts on tumor mutation and increases the chances of a positive response to treatment, offering real benefit to patients and broadening therapeutic options, although there are barriers related to the high cost of these drugs. The arrival of biosimilars in this scenario represents a great achievement for doctors and patients, as they offer the same efficacy and safety ratios with better cost-benefit ratio, "says Ricardo Caponero , clinical oncologist at Hospital Alemão Oswaldo Cruz .

¹ Trademark registered by Amgen, Inc.
² ANVISA, RESOLUTION-RE No. 1,299, of May 16, 2019.
³ Trademark by Genentech, Inc.
⁴ 2018-2019, Ministry of Health, National Cancer Institute.