PURPOSE: As in many countries patient access to high-priced original biological medicines is restricted or they are even unavailable, the main value proposition of multisource biological products (biosimilars and off-patent originals) is not only to save money, but to increase patient access to treatment. While prescribing biosimilar medicines for patients naive to biologics is well-accepted practice in several countries, switching clinically stable patients from an originator to a biosimilar is not supported by all key stakeholders. In this workshop policy measures on competition in the off-patent biological market are discussed also from a health economic perspective. DESCRIPTION: The session will start with a multiperspective overview (academic, payer, industry viewpoint) on off-patent biological medicines policies, including pitfalls of current practices. This will be followed by a discussion on potential policy recommendations, including: 1) supply-side policies: expedited price and reimbursement process facilitating the timely market entry of biosimilars; 2) demand-side policies: measures (e.g. gainsharing and target agreements) supporting access to more affordable multisource biological medicines for eligible patients with the introduction of biosimilar medicines and switch of patients between off-patent original biologics and biosimilar alternatives under medical supervision; 3) ex-ante and ex-post policy approaches to increase understanding and confidence to mitigate uncertainty related to switching between original biological medicines and biosimilar alternatives; and 4) guidance to physicians and other healthcare professionals on how to educate appropriately patients about biosimilar medicines. Health economic implications of implementing these policy measures including selection of appropriate type of economic evaluation, selection of policy-relevant comparator and data availability will also be addressed. In an interactive session, participants will have the opportunity to discuss the proposed policy measures presented by the panel balancing between maximising patient access through competition from biosimilars and long term sustainability of the off-patent biological market.