Biosimilars offer a chance to improve access to, and reduce spending on, life-saving biologic therapies. But could regulators do more to support the market? While experts believe significant regulatory progress has been made in recent years, clarity is distinctly lacking on certain issues, such as interchangeability and naming.
FirstWord’s Biosimilars: Regulatory Outlook provides insight and opinion on why. This 64 page report gives in-depth and candid views on what eight industry and biosimilar experts see as the areas that require the most attention within biosimilar regulation.
See the full list of industry and biosimilar experts
You’ll discover expert concerns and views on critical, market-shaping issues, and understand how they see biosimilar regulations evolving in the future in areas such as indication extrapolation, interchangeability, naming, terminology and the amount and type of clinical data needed to support regulatory approvals.
“The EMA has set the tone when it comes to biosimilar regulation. A pathway that, quite rightly, is seen as the gold standard pathway around the world.” EU Biosimilars Expert.
Request Sample PagesGet answers to key questions about the regulation of biosimilars, and how the area is set to evolve:
Other experts interviewed for the purposes of this report – who requested anonymity due to the content of their comments – include a biosimilars expert working for a European biotech company, the global head of biologic strategy at a leading European biotech company, the global strategy and commercial lead for a US based biosimilars company, and industry experts from EU and US pharma companies. Emailed comments to specific questions were also received from a spokesperson at Germany’s Paul Ehrlich Institute, one of Europe’s leading regulatory bodies.
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