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Sustainability of biosimilars in Europe

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Biologicals accounted for US$277 (Euros 238) billion in sales globally in 2017 and are projected to reach US$452 (Euros 388) billion by 2022. Biosimilars are making up an increasing part of this total, with the European biosimilar market being the most mature. According to Research and Markets, the biosimilar market in Europe reached US$2 billion in 2017 and is expected to exceed US$9 billion by 2023, at a compound annual growth rate (CAGR) of 29% during 2017−2023.

In 10 developed markets alone, US$45 (Euros 38) billion of spending on biologicals is now estimated to be exposed to competition from biosimilars, and another US$52 (Euros 44) billion is expected to lose patent protection from 2019 to 2022. By 2027, 77% of current spending on biologicals is expected to be subject to some form of competition. Use of biosimilars in the EU5 countries (France, Germany, Italy, Spain, UK) alone stands to offer savings of more than Euros 10 billion between 2016 and 2020.

Despite these obvious benefits, according to a new report by the IQVIA Institute for Human Data Science, to sustain the market for biosimilars in the long term, ongoing benefits for all stakeholders must be ensured. Essential elements of sustainability, according to the report, include patient access, physician prescription choice, management of existing healthcare budgets for payers, a healthy level of competition and supply, and product safety and quality.

Specific elements for strengthening sustainability of biosimilars in Europe suggested in the report include:

Patient access	Maintain a regulatory environment and clinical guidelines favourable to biosimilar approval and uptake Ensure guidelines and policies support smooth switching
Physician choice	Maintain prescription freedom Ensure availability of multiple products Create incentives that foster biosimilar uptake
Safe and high quality biologicals	Incentivise both originator biological and biosimilar manufacturers to continue innovating Implement payer purchasing mechanisms that include criteria other than price, thus encouraging the provision of additional value, e.g. patient services, design elements, formulations, etc.
Stakeholders	Maintain involvement of all relevant stakeholders in discussions and decision-making for biosimilars Balance price pressures with requirements for long-term market sustainability
Healthcare budgets	Incentivise the uptake of biosimilars Design incentives considering the needs of target physicians and care institutions
Competition	Sustain healthier levels of competition with multiple-winner tenders as compared with single-winner tenders Make purchasing decisions based on additional criteria beyond price, thus incentivising biosimilar manufacturers to innovate in areas to support patients and providers
Supply	Sustain a healthy supply of biologicals to the market, by enabling access of both originator and biosimilar products Encourage multiple manufacturers to function within a market through multiple-winner tenders/contracts reducing the potential risk of shortages

The authors of the report concluded that ‘by simultaneously securing aspects of sustainability, including physician prescription choice, a means to manage healthcare budgets, and healthy levels of competition, supply, and product safety and quality, the biosimilars marketplace offers to bring with it lower costs and increased patient access to valuable biologicals, with benefits likely to increase over time’.

Editor’s comment
Readers interested to learn more about sustainability of biosimilars in Europe are invited to visit www.gabi-journal.net to view the following manuscripts published in GaBI Journal:

Trends and challenges in biosimilars pricing and reimbursement policies in Europe and beyond

EU Member States have tools to reduce costs of bestseller biologicals but can they use them?

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Source: IQVIA, Research and Markets