Type of information: Positive opinion for the granting of a Market Authorisation in the EU
Product name: Kanjinti® - ABP 980
Compound: biosimilar version of trastuzumab - Herceptin®
Therapeutic area: Cancer - Oncology
- biosimilar/monoclonal antibody. ABP 980 is being developed as a biosimilar to trastuzumab (Herceptin®), 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. The active ingredient of ABP 980 is a humanized monoclonal antibody that has the same amino acid sequence as trastuzumab. ABP 980 has the same pharmaceutical dosage form and strength as trastuzumab. It binds with high affinity and specificity to HER2 leading to the inhibition of proliferation of tumour cells that overexpress HER2.
- Amgen and Allergan are collaborating on four oncology biosimilar medicines, including ABP 980 which is the second to be submitted for FDA approval.
Company: Amgen (USA - CA) Allergan (Ireland)
Disease: breast cancer, gastric cancer
- • On March 22, 2018, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive
opinion, recommending the granting of a marketing authorisation for Kanjinti®, intended for the treatment of breast and gastric cancer. The drug will be available as powder for concentrate for solution for infusion (150 mg and 420 mg). Kanjinti® is a biosimilar medicinal product. It is highly similar to the reference product Herceptin®
(trastuzumab), which was authorised in the EU on 28 August 2000. Data show that Kanjinti® has comparable quality, safety and efficacy to Herceptin. The full indication is:
Kanjinti is indicated for the treatment of adult patients with HER2 positive metastatic breast cancer (MBC):
- • 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 MBC, not previously treated with trastuzumab.
- Kanjinti® 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 Kanjinti therapy, for locally advanced (including inflammatory) disease or tumours >2 cm in diameter
- • On July 31, 2017, Amgen and Allergan announced the submission of a Biologics License Application (BLA) to the FDA for ABP 980, a biosimilar candidate to Herceptin® (trastuzumab). The BLA submission includes analytical, pharmacokinetic and clinical data, as well as pharmacology and toxicology data. The Phase 3 comparative efficacy, safety and immunogenicity study was conducted in adult female patients with HER2-positive early breast cancer.
Submission of marketing authorization application USA : 2017-07-31
Submission of marketing authorization application UE:
Withdrawal of marketing authorization application USA:
Withdrawal of marketing authorization application UE:
Favourable opinion UE: 2018-03-22
Favourable opinion USA:
Orphan status USA:
Orphan status UE:
Pediatric exclusivit _USA:
Pediatric exclusivity UE: