May 4, 2015
By Mark Terry, BioSpace.com Breaking News Staff
Cranbury, N.J.-based Oncobiologics Inc. announced today that is has finished completion of its new manufacturing facility at its Cranbury headquarters location.
Oncobiologics focuses on the development and commercialization of therapeutic biosimilars, including monoclonal antibodies and fusion proteins. The company currently has seven molecules in its pipeline with four more planned. It claims a potential $100 billion in global revenue at the time the patents expire.
Biosimilars are biological products that are “interchangeable” or have a “biosimilar” function as an FDA-licensed product. The Patient Protection and Affordable Care Act (ACA) signed into law in 2010 made an abbreviated licensure pathway for biosimilars.
Oncobiologics has seven biosimilar products in its pipeline ranging from preclinical development to Phase III trials. The pipeline products are biosimilars for Humira (AbbVie ), Avastin, Actemra and Herceptin (Genentech , Erbitux (Bristol-Myers Squibb Company , Prolia (Amgen , and Simponi (Johnson & Johnson /Janssen).
The new facility will use multiple technologies for rapid deployment of commercial-scale manufacturing. The company utilized single-use technology, which allowed the facility to be designed and constructed in less than a year. A previous in-house clinical manufacturing facility went from design to opening in less than six months using the same technology.
“The completion of our Biologics Manufacturing Center is a watershed achievement for Oncobiologics, representing the final piece of the BioSymphony business model that we have assembled over the past three years,” said Scott Gangloff, the company’s senior vice president of Development and Manufacturing in a statement. “By fully integrating our CMC development and manufacturing operations at a single site, we are able to expedite technology transfer, resulting in a streamlined path to commercialization.”
The BioSymphony business model is made up of a team of scientific and engineers, collaborative partnership with global CROs and regional commercial partners, and program management team. In 2013 Onciologics formed strategic partnerships with InVentiv.
The new facility, dubbed the 2000-L facility, will be used to manufacture ONS-3010, a biosimilar to AbbVie’s Humira, to be used in an upcoming Phase III clinical trial.
Biosimilars are the hot new focus of many companies. Amgen announced that it had plans to have as many as five biosimilar products on the market by 2019. Novartis AG is selling a biosimilar based on Amgen’s Neupogen, called Zarxio.
Joe Jiminez, chief executive officer of Novartis, however, indicated in August 2014 that he did not think biosimilars would play a major role in healthcare until 2017 through 2019. However, Joseph Fuhr Jr., a professor of Economics at Widener University, wrote an article , speculating that biosimilars have potential to save healthcare costs in the U.S. “It is estimated that the potential savings in the U.S. for just 11 biosimilars over the time period from 2014 to 2024 could be $250 million.”
Oncobiologics did not respond to interview requests before deadline.
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