This article, based on the EMA’s European public assessment reports (EPARs) and the FDA’s BLA (biologics license application) reviews, identifies many inconsistencies that require revision of regulatory guidance to ensure faster approval of biosimilars.
Real-world evidence (RWE) has become increasingly important for innovative manufacturers looking to convince reluctant payers that their new medicine has a place in patient care. Indeed, many claim the changing nature of the data landscape in healthcare will revolutionize the way we consider evidence, but does this apply to biosimilars? Is there a real need to look at data from actual clinical practice before or after market entry for these products?
Mergers and acquisitions (M&As) are commonplace across the healthcare landscape. Such consolidation is intended to drive efficiencies and spur growth. Traditionally, such M&A activity has involved horizontal integration — the marriage of similar types of organizations (i.e., a pharmaceutical company and a biotech; a national insurance provider with a regional player). The desired merger of CVS and Aetna, however, introduces a dramatically different dynamic — the vertical integration of two different types of businesses, a pharmacy/drug distribution entity and an insurance company, to create a new type of healthcare system. How will such a new entity impact biosimilar use?
The U.S. biosimilar market is relatively new. It took another two years for the FDA to issue the first draft guidelines for developing and registering a biosimilar in the United States, and another three years until the first biosimilar was approved.