A 5-Step Guide To Achieving Your Biosimilar Milestones On Time

Over the next decade, a number of blockbuster biologics will lose their patent exclusivity, and as a result, the biosimilar market will be abundant with opportunity for developers. However, biosimilar development comes with its own unique challenges, including selecting the ideal market for product launch, manufacturing a biosimilar with no clinically meaningful differences from the reference product, and procuring regulatory approval amid rapidly evolving guidance. To increase patient access to these vital drugs, biosimilar developers must build a robust approach to development and manufacturing.

To successfully trod this path, consider the key milestones along the way, including reference product selection, analytical characterization, clinical trials, regulatory approval, and commercial launch. With these milestones in mind, develop a plan that considers which market demonstrates patient need, how best to achieve compliance with regulators, what trial protocols to implement, and how to ensure speed, efficiency, and quality across your manufacturing processes.