Stake Your Claim: How Indian Biosimilar Companies Are Poised To Succeed In The Global Market

With many blockbuster biologics slated to lose their patent exclusivity over the next decade, the market is rife with potential to usher in a new era of biosimilars that offer the potential to lower drug costs and increase access to lifesaving therapies. Launching a biosimilar requires a highly specialized approach, particularly when it comes to navigating the regulations of your target market. In India, biosimilar developers have already had marked success launching biosimilars domestically. In anticipation of the upcoming patent cliff, many are considering how to launch a biosimilar in highly competitive markets like the U.S. and Europe.

To succeed in these new markets, Indian biosimilar developers must prioritize compliance and innovation. This includes committing to GMP manufacturing protocols and quality standards to maintain compliance with FDA, EMA, and ICH standards. Furthermore, it is critical to leverage state-of-the-art analytic techniques to build a robust data package for regulatory submission. Download the full article to learn more about how Indian developers can design their biosimilar approach strategically.