Most pharmaceutical companies work with an average of seven bioanalytical labs in a given year, taking time and scientists away from important research and development initiatives. There’s a better way. Learn more.
Three biosimilars for rheumatoid arthritis (RA) were approved by the FDA last year, but the regulatory pathway in the US is still considered a new frontier, especially when compared to regulatory guidance in the EU. With our global industry’s growing interest in developing biosimilars, it’s critical that sponsors have a clear understanding of key clinical issues and develop a strategy for navigating today’s regulatory environment.
Today, RA studies are taking longer and require more sites to complete. With so few patients actually participating in clinical trials, what does the industry need to do to attract more RA patients to participate in clinical trials?
The approval of novel orphan drug designations continues to grow, while many existing rare disease therapies are receiving approval for expanded indications. With this increase and broadening class of products, including some that target the same mutation or molecular defect, sponsors face new and significant market access challenges in securing reimbursement.