About Oncobiologics

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.

Product Pipeline
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.

Our goal is to utilize the BioSymphony Platform to identify, develop, manufacture and commercialize technically challenging and commercially attractive mAb biosimilars on an accelerated timeline in a cost-effective manner, initially in the disease areas of immunology and oncology. In order to achieve this goal, we have adopted a strategy to leverage the BioSymphony Platform and its capabilities to provide funding for our biosimilar development program while we continue to develop our pipeline. The key elements of our strategy include:

Maximizing our Biosymphony Model.    We are augmenting our BioSymphony Platform to add capacity and capability to provide CDMO services beginning in 2019 to provide development and bulk drug manufacturing for development stage biotechnology and biopharmaceutical companies. We believe that this strategy will allow us to fund and achieve commercial readiness for our pipeline of biosimilar product candidates.

Rapidly advancing our lead biosimilar product candidates through late-stage clinical development in emerging markets.    We recently outlicensed the remaining emerging markets rights to our most advanced clinical-stage product candidates, ONS-3010 and ONS-1045, and intend to rapidly commercialize these assets with our partner to begin generating revenue in 2020. We believe that this strategy will accelerate the development of our biosimilar pipeline and enhance market awareness of our biosimilar product candidates when we prepare to launch in developed markets. (See Product Pipeline)

Expanding our pipeline to include innovative mAb candidates.    We plan to initiate development of an innovative mAb candidate in early 2018. We believe that this opportunity can be exploited with a small investment and could potentially begin generating revenues in 2021.

Advancing our pre-clinical biosimilar pipeline towards clinical development.    We will continue to build our pipeline of early stage biosimilar product candidates for further development and commercialization. We believe that the long term value of our company will be driven by the launch of multiple biosimilar products from our pipeline.

Seeking opportunities to maximize the value of our pre-clinical and clinical pipeline via co-development partnerships and/or licensing the development and commercialization rights where appropriate.    We currently intend to enter into strategic collaborations and partnerships with biotechnology and pharmaceutical companies in the United States and other regions. We believe this strategy will allow us to maximize the impact of our financial resources and result in increased commercial value of our development programs.