Oncobiologics is a clinical stage biopharmaceutical company focused on identifying, developing, manufacturing and commercializing complex biosimilar therapeutics. Our current focus is on technically challenging and commercially attractive monoclonal antibodies (mAbs), in the disease areas of immunology and oncology. Our strategy is to cost-effectively develop these biosimilars on an accelerated timeline, which is fundamental to our success and we believe positions us to be a leading biosimilar company.
We have leveraged our team’s biopharmaceutical expertise to establish fully integrated in-house development and manufacturing capabilities, which we refer to as our BioSymphony™ Platform. Oncobiologics’ platform addresses the numerous complex technical and regulatory challenges in developing and commercializing mAb biosimilars and was designed to provide significant pricing flexibility.
Oncobiologics is currently developing a portfolio of eight commercially attractive mAb biosimilars. The company’s most advanced assets, ONS-3010 (a biosimilar of Humira®) and ONS-1045 (a biosimilar of Avastin®) have both successfully completed Phase I trials. We have initiated Phase 3 preparatory activities for ONS-3010 and ONS-1045.
Oncobiologics' goal is to utilize its BioSymphony Platform to identify, develop, manufacture and commercialize technically challenging and commercially-attractive mAbs on an accelerated timeline in a cost-effective manner, initially in the disease areas of immunology and oncology. The key elements of our strategy are:
Rapidly advancing our lead product candidates through late-stage clinical development and continuing to advance our preclinical pipeline. ONS-3010 and ONS-1045 are our most advanced clinical-stage product candidates. In the first quarter of 2015, ONS-3010 met its primary and secondary study endpoints in a Phase 1 clinical trial and we are preparing to commence enrollment in a confirmatory Phase 3 clinical trial in 2016. Our second product candidate, ONS-1045, met its primary and secondary study endpoints in a Phase 1 clinical trial in October 2015 and we are advancing development of ONS-1045 to be Phase-3 ready in 2016. In addition to our advanced product candidates, we have identified six preclinical candidates. Our most advanced preclinical candidates, ONS-1050 and ONS-4010, are ready to enter Phase 1 clinical trials in 2016 and 2017, respectively, pending successful completion of comparative analytical and in vitro functional studies. (See Product Pipeline)
Employing our expertise in product development to further expand our pipeline.We use a comprehensive approach to identify both near-term and future biosimilar targets that will further enhance and sustain our growth. In particular, we periodically evaluate approved complex biologics using a multi-faceted selection criteriato identify reference products that have a potential for significant commercial opportunity.
Cost effectively developing and manufacturing mAb biosimilars in an accelerated timeframe. Our internal capabilities allow us to employ a seamless transition between development and manufacturing, significantly reducing the time and cost of biosimilar development. We utilize single-use technology that reduces costs of manufactured goods as compared to traditional manufacturing methods. These integrative features of our in-house capabilities permit us to initiate current good manufacturing practice (cGMP) manufacturing within six weeks of completion of process development as compared to traditional technology transfers that can take six months or more. We believe these cost reductions will enable significant pricing flexibility, and will be fundamental to establishing long-term leadership in the biosimilar industry.
Continuing to invest in and expand our in-house manufacturing capabilities. We believe our in-house manufacturing capabilities offer us competitive advantages in the biosimilar industry. Our current manufacturing facilities and infrastructure are sufficient to support the clinical development of our pipeline and the commercialization of our two most advanced product candidates. Further, given the modular nature of our facilities and infrastructure, we are able to rapidly and cost effectively expand our capacity to support our future manufacturing needs as we continue to expand our pipeline of product candidates.
Maximizing the value of our pipeline by retaining development and commercialization rights in the United States and continue to selectively out-license to ex-U.S. markets.The United States is the largest potential biosimilar market in the world and we intend to retain U.S. rights to select product candidates while entering into additional strategic collaborations and partnerships with biotechnology and pharmaceutical companies in other regions. We believe this strategy will maximize the commercial value of our development programs.