Rheumatoid Arthritis Biosimilars: Regulatory and Clinical Considerations

Three biosimilars for rheumatoid arthritis (RA) were approved by the FDA last year, Rheumatoid Arthritis Biosimilarsbut the regulatory pathway in the U.S. 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. Continue reading