Table 3.

Recommendations to overcome barriers to market access of biosimilar monoclonal antibodies in the European Union.

Barrier	Recommendation
Manufacturing process	• Invest initially in advanced production processes with the help of single-use technology, buy-in of experience or outsourcing
Regulatory process	• Gain experience with the regulatory process and establish alignment between stakeholders
Intellectual property rights	• Limit patent litigation • Eliminate evergreening benefits • Build out further the unitary patent and unified patent litigation system within the European Union
Lack of incentive	• Create demand-side policies • Disseminate objective information
Impossibility of substitution	• Change attitude toward biosimilar switching/substitution, starting with physician and patient education
Innovator's reach	• Differentiate the biosimilar by service offerings • Use an appropriate comparator in cost-effectiveness analyses