Amgen is planning UK launch .
Company cannot confirm the date of availability of ABP215 in the UK .
Has been available in the US since Oct 17 .
Approved for the treatment of various cancers, combined with other agents: metastatic carcinoma of the colon, rectum, breast; unresectable advanced, metastatic or recurrent non-squamous non-small cell lung cancer (NSCLC); advanced/metastatic renal cell cancer; epithelial ovarian, fallopian tube, or primary peritoneal cancer; metastatic carcinoma of the cervix .
Amgen also submitted an MAA for a bevacizumab biosimilar called Kyomarc but withdrew the application. Based on the review of the data at the time of the withdrawal, the CHMP had no major concerns and was of the provisional opinion that Kyomarc could have been approved for the treatment of the cancers listed above - see EMA questions and answers .
CHMP recommends EU approval for various cancer indications .
Approved in US .
Patent expiry including paediatric extension 06/20 .
FDA’s Oncologic Drugs Advisory Committee voted 17-0 to recommend approval of ABP 215 in each of the approved indications .
Marketing Authorisation Application submitted to the EMA, based on non-clinical data plus the results of the PIII clinical trial. Amgen-Allergan believe that this will be the first bevacizumab biosimilar application submitted to the EMA .
Filed in US. Amgen-Allergan based the application in part on a PIII study of patients with non-squamous NSCLC .
Reference product primary conditions are colorectal cancer, non-squamous NSCLC, glioblastoma, RCC, breast cancer & ovarian cancer .
The PIII trial reported to meet its primary outcome involved 642 patients. Amgen believes the positive NSCLC study will eventually support ABP 215´s approval in all 6 cancers for which Avastin is already indicated. But Amgen and Allergan will have to wait until Avastin´s patents run out, not expected until 2019 in the US and 2022 in Europe .