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Date: 2018-02-13

Type of information: Granting of a Market Authorisation in the EU

Product name: Herzuma® - CT-P6

Compound: biosimilar version of of trastuzumab - Herceptin®

Therapeutic area: Cancer - Oncology

Action mechanism:

  • biosimilar product/monoclonal antibody. Trastuzumab is a recombinant DNA-derived humanized monoclonal immunoglobulin G1 kappa antibody approved in many regions for the treatment of HER2-overexpressing early breast cancer, metastatic breast cancer and metastatic gastric cancer.
  • Celltrion and Teva entered into an exclusive partnership to commercialize CT-P6 and CT-P10 in the U.S. and Canada in October 2016 . As part of the agreement, Teva is responsible for all commercial activities in the U.S. and Canada, pending regulatory approvals for both products. Celltrion is responsible for completing all clinical developments and regulatory activities.
   

Company: Teva Pharmaceuticals (Israel) Celltrion (South Korea)

Disease:

  • HER2-overexpressing breast cancer,
  • HER2-overexpressing  metastatic gastric cancer

Latest news:

  • • On June 18, 2018, Celltrion announced that the company has made a resubmission to the FDA to obtain its marketing approval for CT-P6, a proposed mAb biosimilar to Herceptin® (trastuzumab). Celltrion submitted its abbreviated Biologics License Applications (aBLAs)  CT-P6 to the FDA in May of last year, respectively. However, it received CRLs (complete response letters) from the FDA related to the warning letter issued by the FDA in January 2018, related to the manufacturing facility in Incheon, South Korea. FDA has notified Celltrion of its re-inspection schedule regarding regular audit results, and separately from this procedure, it has confirmed the resumption of the review procedure for the  proposed biosimilar upon the resubmission of the aBLAs.
  • • On February 13, 2018, the European Commission (EC) approved Herzuma® (trastuzumab biosimilar) for the treatment of patients with early breast cancer, metastatic breast cancer, or metastatic gastric cancer whose tumors have either HER2 overexpression or HER2 gene amplification
  • Herzuma® is the third biosimilar from Celltrion’s portfolio approved by the EC.
  • • On December 14, 2017, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation for Herzuma®, intended for the treatment of breast and gastric cancer. Herzuma® will be available as a 150 mg powder for concentrate for solution for infusion. Data show that Herzuma® has comparable quality, safety and efficacy to Herceptin.  The full indication is:
  • - Herzuma is indicated for the treatment of adult patients with HER2 positive metastatic breast cancer
  • • as monotherapy for the treatment of those patients who have received at least two chemotherapy regimens for their metastatic disease. Prior chemotherapy must have included at least an anthracycline and a taxane unless patients are unsuitable for these treatments. Hormone receptor positive patients must also have failed hormonal therapy, unless patients are unsuitable for these treatments.
  • • in combination with paclitaxel for the treatment of those patients who have not received chemotherapy for their metastatic disease and for whom an anthracycline is not suitable.
  • • in combination with docetaxel for the treatment of those patients who have not received chemotherapy for their metastatic disease.
  • • in combination with an aromatase inhibitor for the treatment of postmenopausal patients with hormone-receptor positive metastatic breast cancer, not previously treated with trastuzumab.
  • - Herzuma® is indicated for the treatment of adult patients with HER2 positive early breast cancer (EBC):
  • • following surgery, chemotherapy (neoadjuvant or adjuvant) and radiotherapy (if applicable)
  • • following adjuvant chemotherapy with doxorubicin and cyclophosphamide, in combination with paclitaxel or docetaxel.
  • • in combination with adjuvant chemotherapy consisting of docetaxel and carboplatin.
  • • in combination with neoadjuvant chemotherapy followed by adjuvant Herzuma® therapy, for locally advanced (including inflammatory) disease or tumours > 2 cm in diameter
  • Herzuma® should only be used in patients with metastatic or early breast cancer whose tumours have either HER2 overexpression or HER2 gene amplification as determined by an accurate and validated assay.
  • Metastatic gastric cancer: Herzuma® in combination with capecitabine or 5-fluorouracil and cisplatin is indicated for the treatment of adult patients with HER2 positive metastatic adenocarcinoma of the stomach or gastro-esophageal junction who have not received prior anti-cancer treatment for their metastatic disease. Herzuma® should only be used in patients with metastatic gastric cancer (MGC) whose tumours have HER2 overexpression as defined by IHC2+ and a confirmatory SISH or FISH result, or by an IHC 3+ result.
  • • On July 31, 2017, Celltrion and Teva Pharmaceutical Industries announced that the FDA has accepted for review the Biologics License Application (BLA) for CT-P6, a proposed biosimilar to Herceptin® (trastuzumab) which is used for the treatment of Human Epidermal growth factor Receptor 2 (HER2)-overexpressing breast cancer and metastatic gastric cancer.
  • The BLA for CT-P6 includes data for CT-P6 and reference trastuzumab in terms of efficacy, safety, immunogenicity, pharmacodynamics (PD) and pharmacokinetics (PK). These trials were conducted in over 500 patients in 22 countries. CT-P6 has been approved by the Korean Ministry of Food and Drug Safety . Celltrion also filed marketing authorization applications for CT-P6 to the European Medicines Agency in October 2016 . The BLA for CT-P6  has been accepted for filing by the FDA for standard review, with FDA Regulatory Action expected during the first half of 2018.
  • • On April 27, 2017, Celltrion announced that the company submitted the application for sales approval to Japanese Ministry of Health,  Labour and Welfare on 11th to enter the Japanese market for anticancer antibody biosimilar Herzuma®(CT-P6, INN: Trastuzumab) that the company itself developed. The size of the original pharmaceutical market in Japan is estimated to be around 450 billion KRW, and Celltrion is aiming to launch in 2018 after approval of the sale of Herzuma®.

Patents:

Submission of marketing authorization application USA : 2017-07-31

Submission of marketing authorization application UE: 2016-10-00

Withdrawal of marketing authorization application USA:

Withdrawal of marketing authorization application UE:

US authorization:

UE authorization: 2018-02-13

Favourable opinion UE: 2017-12-17

Favourable opinion USA:

Orphan status USA:

Orphan status UE:

Pediatric exclusivit _USA:

Pediatric exclusivity UE:

OTC status:

Other news:

Is general: Yes