Boehringer Ingelheim says it has clinical data in hand that show its biosimilar version of Roche’s cancer blockbuster Avastin is bioequivalent to the brand.
The phase I trial suggests that Boehringer’s BI 695502 candidate has the same biologic profile as Avastin (bevacizumab), a VEGF-targeting antibody that is used to treat colorectal, ovarian, cervical and lung cancer, as well as renal cell carcinoma and glioblastoma.
Avastin has been on the market since 2004 and along with breast cancer drug Herceptin (trastuzumab) has been the mainstay of Roche’s cancer portfolio, bringing in nearly $7bn in sales for the company last year.
Boehringer wants a slice of that market, and in the last few weeks has started the INVICTAN-2 trial comparing BI 695502 to Avastin – both on top of chemotherapy – in patients with non-small cell lung cancer (NSCLC).
The main objective in the trial will be to compare response rates using imaging for the two drugs over 18 weeks of follow-up after starting treatment, with secondary measures including progression-free survival (PFS) and overall survival. The first data is expected to be available in August 2017, setting up a possible filing later that year.
Biosimilar versions of Avastin are already on the market in some emerging markets such as India and Russia, and Boehringer is in a race with several other biosimilar developers aiming to bring Avastin clones to big markets like the US and EU.
Amgen and Allergan have just filed for approval of their ABP 215 candidate with the US FDA, saying they believe this is the first bevacizumab biosimilar application submitted in the US, while Samsung Bioepis, Pfizer and Biocon/Mylan have candidates in late-stage development.
Roche is unlikely to make things easy for them, however, insisting it has patent protection for its brand until 2019 in the US and 2022 in Europe.
BI 695502 is one of two biosimilars Boehringer has in phase III testing along with BI 695501, a version of AbbVie’s rheumatology blockbuster Humira (adalimumab).