Making sense of the rapidly changing biosimilars landscape

The biosimilar landscape is rapidly shifting. Increasing numbers of biologics are nearing patent expiration, creating vast opportunities for developers. However, new regulatory guidance is creating uncertainty as to how to meet data requirements with fewer clinical studies. Evolving therapeutic capabilities mean biosimilar development is being challenged to move past tried-and-true monoclonal antibody development. And, growing competition has created a challenging commercialisation environment for emerging biosimilar products.

This whitepaper explores the changes to the biosimilar landscape that developers should be aware of and the ramifications of these changes on strategies for successful market entry, including recent biosimilar EMA and biosimilar FDA guidelines updates.

Read to explore:

• Market trends in biologics
• Advantages and challenges for developing advanced-modality biosimilars
• Development impacts of new EMA and FDA regulatory shifts and broader biosimilars regulatory expectations
• Strategies for clinical study design under the new regulations
• How biosimilars market competition is shifting
• Key factors driving physician uptake of biosimilars
• The role of payers in biosimilar uptake across the EU, US and APAC
• How originator companies may respond to biosimilar competition

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