The Biopharma Patent Cliff Looms – Design Your Biosimilar Approach Accordingly

By 2030, a wide array of blockbuster biologics are slated to lose their patent exclusivity, opening the market for increased biosimilar development, and as a result, improved accessibility and affordability for patients. Biosimilar R&D is significantly less expensive – 15 to 20 times lower – than development for innovator molecules thanks to the fact that the active ingredients have already been proven to be safe and effective; it also enables faster development timelines.

Your success in biosimilar development depends largely on your team’s ability to conduct thorough market analysis from the earliest stages of development and tailor your approach accordingly. Working with key stakeholders, including patients, providers, and payers, is another critical step to success. From a manufacturing perspective, it is critical to stay closely aligned with the regulatory guidelines in your target market. Download the full paper to learn more about the upcoming patent cliff and key market, manufacturing, and regulatory considerations in biosimilar development.