A biosimilar is developed to be comparable to an approved biologic, with no clinically meaningful differences from the original product. Biosimilars go through an expedited approval process from the US FDA and other Western regulators; the developer of the biosimilar simply has to show that it is safe, pure, and potent enough to act in place of the biologic. Biosimilars are notably less costly than their biologic counterparts, due to their ability to build off of already existing biologics and a streamlined approval process. Western companies such as Pfizer and Novartis are leaders in the development of biosimilars, including Zirabev, a Avastin biosimilar used in the treatment of cancer.
India has played a pivotal role in biosimilar research and development, showcasing its expertise by introducing the first biosimilar as a Hepatitis B vaccine in 2000. With a proven track record in creating and testing similar biologics, Indian companies offer valuable experience. Smart Western companies can benefit from this expertise by collaborating with Indian firms to efficiently, affordably, and reliably create and test biosimilars.
The availability of large, modern laboratory facilities in India equipped for biosimilarity testing is a key advantage. These facilities also possess the capability for efficient scale-up if required. Western companies can choose to establish their own facilities in India or explore partnerships with established Indian organizations. Amritt, a dependable intermediary, facilitates connections between Western companies and vetted outsource partners and suppliers in India, ensuring a smooth and reliable collaboration.