EMA Maintains Approval for Amgen's Kanjinti and Updates Post-Market Regulatory Records
Significance of EMA's Regulatory Record Update
The European Medicines Agency (EMA) has updated the post-market procedure record for Kanjinti's EPAR on August 11, 2026, while the marketing authorization granted on May 16, 2018, remains valid. This is not a new approval or indication expansion but rather a lifecycle management procedure reflecting post-authorization changes and safety monitoring. The marketing authorization holder is Amgen Europe B.V., and the product is a biosimilar used in the treatment of breast and gastric cancer. Therefore, this update should be interpreted as an event demonstrating ongoing regulatory compliance and eligibility for participation in European tender markets, rather than a re-evaluation of clinical value.
Clinical Basis of HER2-Targeted Biosimilar
Kanjinti's active ingredient is trastuzumab, a monoclonal antibody that targets the human epidermal growth factor receptor 2 (HER2) on tumor cells. The reference product is Herceptin (trastuzumab) from Roche Holding AG (ROG.SW), and Kanjinti is in the approved and marketed stage. The key LILAC Phase 3 trial (NCT01901146) randomized 725 patients with HER2-positive early breast cancer, with a central laboratory-assessed pathological complete response rate of 48% for Kanjinti and 42% for Herceptin. The hazard ratio was 5.8 percentage points, and the 90% confidence interval was -0.5% to 12.0%, which falls within the pre-defined equivalence range, supporting the regulatory conclusion that there is no clinically meaningful difference.
Approval History and Competitive Landscape
The EMA's Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion on March 22, 2018, and the marketing authorization was granted on May 16 of the same year, with no separate advisory committee (AdComm) vote. The US FDA approved Kanjinti as trastuzumab-anns on June 13, 2019. Direct competitors include Herzuma from Celltrion Inc. (068270.KS), Ontruzant from Samsung Bioepis, and Trazimera from Pfizer Inc. (PFE), all of which are trastuzumab biosimilars based on Herceptin. In early HER2-positive breast cancer, trastuzumab and chemotherapy form the treatment backbone, and in high-risk patients, the combination with Perjeta (pertuzumab) is used. Biosimilar competition is focused on price, supply, and bidding execution rather than efficacy differentiation.
Impact on Market and Amgen's Performance
Roche's Herceptin sales decreased from 1.381 billion Swiss francs in 2024 to 1.028 billion Swiss francs in 2025 due to the expansion of biosimilars, a decrease of 22% on a constant currency basis. This figure shows that while the trastuzumab family still has an original sales base of over 1 billion Swiss francs, price competition has intensified structurally. Amgen Inc. (AMGN) did not disclose Kanjinti's sales separately but reported biosimilar sales of $683 million in 2025, up from $667 million in 2024. Maintaining approval and updating regulatory documents is more about defending this sales base and access to hospital tenders than being a new growth driver.
In the short term, the EMA's continued approval and the update of post-market records allow Amgen (AMGN) to continue supplying Kanjinti in European hospital tenders, but it is not a factor that will lead to a surge in sales due to new approvals. The LILAC Phase 3 trial showed a central laboratory-assessed pCR of 48% versus 42% and a hazard ratio of 5.8 percentage points, which researchers and prescribers can use as evidence of clinical similarity compared to Herceptin. In 2025, Herceptin sales were 1.028 billion Swiss francs, a 22% decrease, and Herzuma, Ontruzant, and Trazimera compete on price and supply stability, leading to continued pressure on profitability. In the medium to long term, this contributes to the defense of Amgen's biosimilar sales of $683 million, including Kanjinti, and the credibility of its follow-up portfolio, but the investment effect depends more on net price and bid win rate than on market share.
Source: EMA (ema)