Table 2.

Barriers to market access of biosimilar monoclonal antibodies in the European Union.

Manufacturing process	• Expensive • Complex
Regulatory process	• Uneven contribution and acceptation by stakeholders
Intellectual property rights	• Innovator patents • Prolongation of exclusivity rights • Patent disputes
Lack of incentive	• Difficult to differentiate • Limited price discounts • Limited knowledge and acceptance • Burden of change
Impossibility of substitution	• No interchangeability • Little to no policies in favor of switching and substitution
Innovator's reach	• Strong ties with physicians and patients • Competitive rebates