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Martin Åmark, CEO, Xbrane Biopharma in crafting p
olicies that facilitate biosimilar production. “One of the fundamental pillars for the successful uptake policies in Norway has been the government leadership in designing a biosimilar policy framework, involving multi-stakeholder engagement and an active roadmap for policy interventions supporting their ambition for biosimilar medicines’ role in the healthcare system,” says Maréchal-Jamil. “In the Nordic region, Sweden can certainly be showcased as an active-learning example, factoring experience in the design of the framework. Swedish officials recently outlined the implementation of a tiered tendering approach, which supports multi-actors in the market and healthy competition, as well as implementing benefit-sharing schemes where the benefits of the introduction of biosimilar medicines in clinical practice are re-invested in tangible improvements for the healthcare community.” benefits that these important medicines offer for patients, physicians, payers and healthcare systems in the longterm,” adds Parkler. Additional incentives to drive the use of biosimilars over more expensive originator biologics could include regulators accepting interchangeability of medications and automatic substitution, says Åmark. Communicating the safety, effectiveness and lower cost of biosimilars to patients and healthcare providers also helps, according to Maréchal-Jamil, including disseminating real-world data about the value and benefits seen across the healthcare community through the use of biosimilar medicines. 112 NORDICLIFESCIENCE.ORG In terms of production, some experts maintain that revising the regulations for clinical trials could eliminate redundancy in testing. Lowering the primary requirements for Phase III trials and relying more on evidence from analytical data and phase I studies would help manufacturers get biosimilars to market faster, says Åmark. Maréchal-Jamil agrees, “The regulatory science advances also need to factor in the experience for optimal efficiency in both the development and registration of biosimilar medicines.” The Nordic countries, especially Sweden and Norway, have been leaders The savings from using biosimilars are going to become increasingly critical as healthcare costs continue to rise. “The value and benefits of biosimilar utilization in terms of re-investment in health and patient care are very clear and documented,” notes MaréchalJamil. Among these are more patients receiving treatment earlier because of the lower costs of the medications, and allowing the savings to be invested in other areas of care, such as expanding a hospital’s nursing staff, she notes. “Biosimilars are one of the most promising things to reduce healthcare costs in the coming decades,” adds Åmark. “They are the key to reducing costs and the key to making drugs accessible to broader populations.” NLS