|Oncobiologics CEO Pankaj Mohan|
CRO inVentiv Health and biotech partner Oncobiologics have a plot to cash in on the burgeoning market for knockoffs of biotech drugs, and the two have begun development on a biosimilar of the blockbuster Humira.
The Netherlands has approved the pair's study protocol and green-lit a Phase I trial, which Oncobiologics expects will wrap up by the end of the year. Under the pair's deal, inVentiv has signed on to take care of studies and bioanalytics, and, once the duo's biosimilars are up for sale, the two will broaden the deal to make use of the CRO's commercialization network.
AbbVie's Humira, which grossed nearly $10.6 billion last year, is the first target of inVentiv and Oncobiologics' biosimilars campaign, which will also target Rituxan, Avastin, Herceptin and Erbitux.
"This represents the culmination of two years of hard work by our team, as well as proof-of-concept for our biosimilars business model, BioSymphony, which integrates our world-class CMC and manufacturing capabilities with the external clinical expertise of inVentiv Health, a top global CRO, and several regionally strong commercial partners around the world," Oncobiologics CEO Pankaj Mohan said in a statement.
Biosimilars development has become a particular focus for inVentiv. In March, they signed a deal with Australia's Proteomics International to expand its characterization services. That collaboration will bridge Proteomics International's structural characterization and quality control testing of proposed and reference drugs to inVentiv's existing services in bioanalytics, clinical development and commercialization, the company said.
- read the statement