NeuClone has partnered with Serum Institute of India to develop ten biosimilars for global registration, following FDA and EMA guidelines. NeuClone and Serum Institute have invested in state-of-the-art facilities purpose built for biosimilar production. NeuClone is responsible for initial biosimilar development, analytical characterisation and biosimilarity determination, while Serum Institute is responsible for clinical and commercial scale manufacture.
This partnership exemplifies our strategy of developing the most cost effective, high quality biosimilars for global distribution.
Upon completion of all clinical programs, NeuClone will retain all rights in developed world markets, including the United States, Australia, New Zealand, Europe, Canada, Japan, South Korea and China. Serum Institute will retain marketing rights for all biosimilars in countries across rest-of-world (RoW) markets.
Serum Institute of India is the world’s largest vaccine manufacturer by number of doses produced and sold globally, at over 1.3 billion doses. As such, Serum Institute is also the largest global manufacturer of complex biologicals, including proteins, monoclonal antibodies and vaccines. Approximately two in every three children immunised globally are vaccinated with one of their products, which have been used over decades in approximately 170 countries.
Serum Institute has a strategic and commercial vision to replicate its success in vaccines with biosimilars – making them available at sufficient volume, quality and price to deliver globally.
Outside their historical business dedicated to vaccines, Serum Institute also developed a biosimilar of EPO. The Institute’s introduction of biosimilar erythropoietin (EPO) to the Indian market is indicative of the power of quality, capacity and corporate branding for trusted products. Serum Institute’s biosimilar EPO was the 11th alternative to the originator sold by Amgen (Epogen), Johnson & Johnson (Eprex) and other EPO products classified in India as similar biologics. Despite entering the Indian EPO market late, Serum Institute became the largest provider of EPO in India, after only eighteen months.
Serum Institute’s fully human IgG1 monoclonal antibody, Rabishield® is another demonstration of their ability to develop, manufacture and commercialise high quality and affordable complex biologics.
In 2017, Rabishield® was launched in collaboration with the University of Massachusetts Medical School. The product provided a ‘first of its kind’ treatment in a more potent, easier to manufacture form, at a significant discount to existing treatments. Rabishield® fulfilled unmet patient demand in countries where existing standards of care were financially out of reach, and where rabies was continuing to cause significant loss of life.