2014年1月20日,韩国Celltrion公司近日宣布，单抗生物仿制药Herzuma(trastuzumab，曲妥珠单抗)获韩国食品药品安全部(MFDS)批准，这是该公司获批的第二种单抗生物仿制药。
具体而言，MFDS已批准Herzuma用于治疗早期和晚期(转移性)HER2阳性乳腺癌、以及晚期(转移性)胃癌的治疗。Herzuma能够激活人体免疫系统，抑制HER2信号通路，从而靶向并摧毁肿瘤。
Herzuma为罗氏(Roche)单抗药物赫赛汀(Herceptin，通用名：trastuzumab，曲妥珠单抗)的生物仿制药。Herceptin是罗氏的乳腺癌重磅药物，2012年全球销售额超过63亿美元，韩国市场规模约为800亿韩元(约合8000万美元)。目前，还没有乳腺癌单抗生物仿制药在欧洲或其他发达国家完成临床试验，使得Celltrion在乳腺癌单抗生物仿制药市场中处于有利地位。
此前，该公司单抗生物仿制药Remsima(infliximab，英夫利昔单抗)已于2013年9月获欧洲药品管理局(EMA)批准，这是全球获发达国家批准的单抗生物仿制药，是强生(JNJ)关节炎重磅药物Remicade(类克，通用名：infliximab，英夫利昔单抗))的生物仿制药。
目前，Celltrion是全球第二大单抗药物生产企业，也是亚太地区的单克隆抗体药物生产企业
New Drugs Online Report for trastuzumab biosimilar (CT-P6)
Information
Generic Name: trastuzumab biosimilar (CT-P6)  
Trade Name: Credima (EU), Herzuma 
Synonym: CT-P6, CT-P06 
Entry Type: Biosimilar  
Development and Regulatory status
UK: Phase III Clinical Trials 
EU: Phase III Clinical Trials 
US: Phase III Clinical Trials 
UK launch Plans: Available only to registered users
Actual UK launch date:  
Comments
Mar 15: Celltrion received approval for its trastuzumab biosimilar from South Korea´s Ministry of Food and Drug Safety in Jan 2014, for treatment of early and metastatic HER2-positive breast cancer, and metastatic gastric cancer [12].
13/03/2015 12:22:37 
Feb 15: Trastuzumab biosimilar not currently being evaluated via the EU centralised procedure; it appears the application has yet to be filed [11].
13/03/2015 12:20:51 
The patent on Herceptin expires in 2014 in Europe and in 2019 in the US and the drug could be exposed to biosimilar competition in Europe from 2015. [10]
04/06/2014 08:46:01 
May 14: Currently pre-registration in the EU [9].
13/05/2014 11:27:32 
Apr 14: Hospira has won a UK court case overturning two Roche patents on trastuzumab meaning that the drug could be open to biosimilar competition when its main patent expires 28 Jul 14 [6]. Celltrion Hospira and Celltrion will be able to launch CT-P6 after getting the regulatory approval from EMA and it is understood that both companies will seek approval in 2014 [7]. 
16/04/2014 14:51:58 
Jun 13: CT-P6 was filed with the Korean Ministry of Food and Drug Safety on 4 June 2013 [3].
28/06/2013 17:30:08 
The patents on Herceptin expire in Europe in July 2014 and in the US in June 2019 [2].
25/06/2013 14:56:21 
Trial or other data
Sep 15: Estimated primary completion date for PIII trial in 532 patients with HER-2 positive early breast cancer (NCT02162667) is Dec 2016 [13] 
08/09/2015 16:11:02
Apr 14: EudraCT Number: 2013-004525-84. Celltrion is starting a PIII international trial in 532 patients with HER2+ early operable breast cancer (neo and adjuvant therapy) that will evaluate the efficacy and safety of biosimilar trastuzumab (CT-P6) vs Herceptin both given in combination with docetaxel followed by FEC (5-fluorouracil, epirubicin and cyclophosphamide. The primary efficacy endpoint is defined as the absence of invasive tumour cells in the breast and axillary lymph nodes (pathological complete response - pCR) [7]
14/04/2014 11:59:50
Apr 14: PIII study (COMPARE; NCT01084876) compared the efficacy and safety of the trastuzumab biosimilar with Herceptin®, both in combination with paclitaxel, as first-line therapy in patients with metastatic breast cancer. The randomised, double-blind, parallel-assignment study enrolled 475 pts in 15 countries, including India, Romania, Austria, Poland, Bulgaria and Russia. Results were presented at the 49th Annual Meeting of the American Society of Clinical Oncology (ASCO-2013). [5]
02/04/2014 16:49:54
Jun 13: A PIII double-blind, randomized study carried out in Romania, showed equivalent efficacy of CT-P6 to trastuzumab in overall response rate and safety profile in 383 patients with HER2+ metastatic breast cancer in combination with paclitaxel as first-line therapy given every 3 weeks, according to a presentation at ASCO [3]. 
28/06/2013 17:30:41
EudraCT 2011-004468-31: a double-blind, randomised, parallel group, PIII study to demonstrate equivalent efficacy and comparable safety of CT-P6 and Herceptin, both in combination with paclitaxel, in 366 patients with metastatic breast cancer. The primary endpoint is ORR (complete [+ partial response) at 6 months, by RECIST 1.1. The study started Feb 10 [1]
25/06/2013 13:57:10
References  
Available only to registered users
 Category
BNF Category: Other antineoplastic drugs (08.01.05)
Pharmacology: Anti-HER2 monoclonal antibody  
Epidemiology: HER2 positive breast cancer accounts for up to 25% of all breast cancers. On this basis, ~ 550 patients were diagnosed with HER2 positive metastatic breast cancer in England and Wales in 2010 [4].  
Indication: Breast cancer 
Additional Details: early and metastatic, HER2 + 
Method(s) of Administration  
Intravenous infusion 
Company Information
Name: Not Known 
US Name: Celltrion 
Further Information
Anticipated commissioning route (England) NHSE 
High cost drug list? Awaiting Update
Tariff Chemotherapy
Implications Available only to registered users