The biosimilar and innovator biologic markets and regulation have steadily evolved in Europe and the United States, with the European marketplace experiencing the most commercial success. However, the cost of these products – whether innovator or biosimilar – continues to be of global concern, especially as new products will soon emerge from the pipeline.

This session will contemplate what is next for biosimilars in established markets like Europe, and emerging markets like Brazil and China.

• Assessing regulatory and legislative developments impacting the biopharmaceutical industries in each region
• Understanding the economics and market influences
• Considerations for market access, sustainable pricing and reimbursement policies
• Market uptake of biosimilar products
• Biosimilar v. biosimilar litigation in a crowded market

• Understanding the economics and market size, share, growth and influences:
• Considerations for market access, sustainable pricing, and reimbursement policies
• Market uptake of biosimilar products
• Biosimilar v. biosimilar litigation in a crowded market
• Comparing differences in:
• What the regulatory application must show
• Whether decisions related to biosimilarity are made on a case-by-case basis
• Exclusivity period
• Post marketing requirements
• Exclusivity for first interchangeable drug