Celltrion Herzuma receives final EU approval, accelerating competition in HER2 biosimilar market
EU approval clears path for commercialization
Herzuma (trastuzumab), developed by Celltrion (068270), is a biosimilar targeting human epidermal growth factor receptor 2 (HER2) of Roche's Herceptin. The Committee for Medicinal Products for Human Use (CHMP) under the European Medicines Agency (EMA) adopted a positive opinion on December 14, 2017, and the European Commission (EC) granted a marketing authorization valid in all EU member states on February 9, 2018. The approval covers HER2-positive early and metastatic breast cancer and metastatic gastric cancer, marking Herzuma's transition from development to approval and commercialization in Europe.
Equivalence demonstrated in 549-patient Phase 3 trial
The approval was based on the Phase 3 NCT02162667 trial involving 549 patients with HER2-positive early-stage breast cancer. In neoadjuvant and adjuvant therapy, Herzuma showed a pathological complete response rate (pCR) of 46.8% compared to 50.4% for Roche's Herceptin. The 95% confidence interval for the treatment difference was -12.38% to 5.16%, falling within the equivalence range. EMA concluded, based on quality, pharmacokinetics, efficacy, and safety data, that Herzuma has no clinically meaningful difference from Herceptin, and no separate advisory committee (AdComm) voting process was required.
Price realignment in a 2.1 billion Swiss franc market
Roche's Herceptin sales in Europe in 2017 amounted to 2.123 billion Swiss francs, equivalent to approximately USD 2.1 billion at the time. Biosimilar entry promotes price reductions through hospital tenders and insurer negotiations, increasing access to HER2-targeted therapies while eroding original drug sales. From a patient perspective, Herzuma provides an additional intravenous alternative with the same approved indications and comparative clinical evidence, though the actual rate of adoption depends on national prescribing and tender policies and physician acceptance.
Direct competition with first-to-market Ontuzan
Samsung Bioepis' Ontruzant (trastuzumab) received EU approval in November 2017, making Herzuma a second entrant in the market. Following this, Amgen's Kanjinti, Pfizer's Trazimera, and Biocon's Ogivri received approvals in 2018, making price, supply stability, and distribution networks key factors in market share. Celltrion Healthcare leveraged its existing European partners, including Mundipharma, BioGlan, and Convergence, and Herzuma expanded its regulatory reach with FDA approval on December 14, 2018, and Japanese approval on September 21, 2018.
Herzuma's EU approval marks Celltrion's transition of a Phase 3-completed asset into the approval and commercialization stage, entering the 2.123 billion Swiss franc Herceptin market in Europe in 2017. In the short term, competition with Ontruzant in hospital tenders, supply stability, and net pricing by country will determine the speed of sales penetration. In the medium to long term, the entry of Kanjinti, Trazimera, and Ogivri into a multi-player competition will expand treatment access but also pressure biosimilar players on pricing and margins. For researchers and clinical practice, the pCR equivalence and approval for HER2-positive breast and gastric cancers from the 549-patient Phase 3 trial provide a basis for substitution prescribing and real-world data accumulation.
Source: EMA (ema)