Oncobiologics is a U.S. based biotechnology firm focused on the development, manufacture and commercialization of biosimilar versions of leading global biopharmaceuticals. The firm was founded in 2011 by a team of highly accomplished scientists and engineers from leading pharma and biotech organizations. Since its establishment, Oncobiologics has leveraged its scientific strengths and technical infrastructure to rapidly develop a portfolio of therapeutically important and commercially-attractive complex biosimilars (monoclonal antibodies), with its first asset entering Phase I clinical trials in Europe in June 2014 and Phase III in Q1/2015.
Oncobiologics is actively working on seven (7) biosimilar assets, with several others under consideration for future development. A Phase I clinical study of the company’s biosimilar version of Humira has been completed in Europe, with results expected in early 2015. Oncobiologics' next biosimilar, a highly comparable version of Avastin, is expected to enter a Phase I study in Q4 2014, with other molecules following in the first half of 2015. Combined, the marketed versions of the pipeline products referenced above generate more than $40 Billion in annual global revenue.
A core differentiator for Oncobiologics is its BioSymphony™ development model, which provides the unique ability to control molecule development from “DNA to commercial product.” Operating from a fully integrated 35,000 sq. ft. facility in the US, the BioSymphony model includes R&D, Clinical and Commercial Launch capabilities designed to provide scientific rigor, speed and cost efficiencies, so as to deliver a robust scientific package as required by the European EMA and the US FDA. Expert global partners are leveraged for unique functional expertise, including a strategic partnership with one of the top 5 CROs for clinical development and regulatory consulting activities.
The R&D facility is equipped with state-of-the-art equipment that enables advanced orthogonal analytics, formulation and high-throughput process development. The GMP manufacturing facility features the latest 2000 liter single-use technology system which enables scalable production in a small footprint. The facility is capable of clinical manufacturing and commercial launch. The GMP facility has been certified by a QP from Europe.
Oncobiologics is currently engaged in several collaboration discussions with multi-nationals and has already executed licensing agreements for selected molecules and emerging market geographies.
Within three years of its creation, Oncobiologics is one of very few organizations to have successfully advanced a complex monoclonal antibody biosimilar into Phase I clinical study (others include Amgen, Sandoz, Boehringer Ingelheim and Pfizer). This rapid technical success is a validation of the company’s development model and makes it a highly attractive partner for gaining access to the burgeoning global biosimilars market opportunity.