Keyword: Covance

Rheumatoid Arthritis Biosimilars: Regulatory and Clinical Considerations

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.

The Importance of Stakeholder Research in Rare Disease Drug Development

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.