Oncobiologics is a pure-play complex biosimilar company focused on technically challenging and commercially attractive monoclonal antibodies (mAbs), in the therapeutic areas of immunology and oncology. Our strategy is to cost-effectively develop technically challenging biosimilars on an accelerated timeline, which we believe is fundamental to our success and 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.
Oncobiologics is actively working on eight biosimilar candidates. 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 and Phase 3 trial enrollment is anticipated to begin during the first half of 2016.
Oncobiologics utilizes its BioSymphony Platform to develop, manufacture and commercialize technically challenging, cost-effective biosimilars on an accelerated timeline, initially in the therapeutic areas of immunology and oncology.
Rapidly advancing our lead product candidates through late-stage clinical development and continuing to advance our preclinical pipeline. We have a product pipeline of eight biosimilar candidates, two of which are in clinical development (See Product Pipeline). Our fully integrated in-house development and manufacturing capability, and our team’s clinical and regulatory expertise, driven by our entrepreneurial culture, enables Oncobiologics to advance our product pipeline on an accelerated timeline and in an efficient and cost-effective manner. This model is designed to enable significant pricing flexibility, providing us with competitive advantages, and positions us to be a leading biosimilar company.
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. Our integrated in-house capabilities allow 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. Overall, these cost reductions should support 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. Our in-house manufacturing capabilities are designed to 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. We are also selectively entering into strategic collaborations and partnerships with biotechnology and pharmaceutical companies in ex-U.S. regions to maximize the commercial value of our development programs in those regions. Further, licensing revenue obtained from these regional ex-U.S. partnerships will be utilized to partially, or in some cases, fully offset late-stage clinical development costs.
Within four years of its opening, Oncobiologics is one of very few organizations to have advanced two complex monoclonal antibody biosimilars through successful human PK studies and is prosecuting six additional mAb biosimilars in pre-clinical development. This rapid technical success is a validation of the company’s BioSymphony Platform and makes it a highly attractive partner for gaining access to the burgeoning global biosimilars market opportunity.