Oncobiologics Readying Avastin Biosimilar Candidate for Phase III Trials

April 16, 2015
Randi Hernandez

Randi Hernandez was science editor at BioPharm International from September 2014 to May 2017.

The company announced that a pharmacokinetic study comparing ONS-1045 to US- and EU-sourced Avastin will conclude shortly.

 

Oncobiologics announced on Apr. 15, 2015 that it expects to initiate Phase III trials for its biosimilar to Genentech’s Avastin (bevacizumab) following the successful conclusion of a pharmacokinetic study comparing the biosimilar to versions of Avastin that are approved in the United States and European Union. The study will also compare the reference products to each other.

Avastin, which is a vascular endothelial growth factor, is used to treat various cancers. It is also used off-label for the treatment of age-related macular degeneration (AMD) and has been shown to be just as effective as Lucentis for this indication. When diluted to the concentrations called for in ophthalmic indications, Avastin is one-twentieth the price of Lucentis, which sells for approximately $2000 per injection.

According to calculation from BioWorld, Avastin captured $7 billion in revenue in 2013-so it is no surprise that there are more than 20 biosimilars for the medication in various stages of discovery and development. Actavis and Amgen's candidate, ABP 215, will complete Phase III clinical trials in early 2016. Boehringer Ingelheim GmbH's BI 695502 will begin Phase III trials vs. bevacizumab plus chemotherapy in patients with lung cancer. Pfizer's PF-06439535 completed Phase I trials in August 2014, and Phase I trials of Mabxience S.A.'s BEVZ92 are expected to be completed by September 2016.

Oncobiologics is developing the Avastin biosimilar in partnership with inVentiv Health. Oncobiologics has 11 other biosimilars in development, including products for adalimumab, cetuximab, rituximab, and trastuzumab.

Source:
Oncobiologics