Tearing down the barriers to accessing biosimilars


Many European states have adopted strategies to balance their national budgets with special focus on healthcare, because of the financial and economic crisis. The number of European Union (EU) citizens suffering from chronic conditions is expected to increase in the coming years, mainly because of the increase in life expectancy.1 The cost of innovative pharmaceutical drugs is also increasing. Since their introduction in 2006, biosimilars, biological products that are highly similar to reference medicines, have helped save about €1.5 billion in the European Union Five (EU5; France, Germany, Italy, Spain, and the UK) with a further €15 billion anticipated over the next two years.2 This reduction in the cost of treatment is caused by the competition that biosimilars bring to the biopharmaceutical product market, in the same way that generic pharmaceutical products bring competition to the non-biopharmaceutical product landscape.1

Barriers and Strategies for Accessing Biosimilars

Stakeholders’ Acceptance

There is still a lack of knowledge and awareness regarding the use, efficacy, and safety of biologics amongst various stakeholders including physicians, patients, and carers.5 This issue can be addressed by promoting educational and informative approaches to increase awareness about the quality, safety, and efficacy of biosimilar medicines. These approaches could be in the form of appropriate clinical guidelines and/or electronic prescribing systems, resulting in target agreements both at hospital and retail levels.1

Price Comparison Between Biosimilars and Generics

Like generics, biosimilars are expected to be sold at lower prices than their reference medicines. However, the development costs involved with biosimilars are so high (up to €150–250 million) that biosimilars cannot match generics in terms of offering discounts.3 There are savings for biosimilars, however, due to the high fix cost, they cannot be kept as low as the costs for generics. Therefore, to create a favorable market for biosimilars, alternative cost-effective strategies should be implemented, such as providing distinct pricing, and reimbursement policies.1

Legal Issues/Lawsuits

The manufacturers of originator reference drugs are constantly trying to delay the launch of biosimilars by means of several litigations against biosimilar manufacturers. They are also trying to penalize their customers who are trying to move patients to biosimilars. These litigations cannot only delay the launch and uptake of biosimilars but could also impact their affordability.3,4 Such issues can be resolved by providing a comprehensive and detailed description of the biosimilars during the approval stages, thereby reducing uncertainties around patent opposition.1

Worries from Biosimilar Companies

Because of the uncertainty and substantial cost involved in bringing a biosimilar to market, developers are anticipating the success of biosimilars with caution,5 which necessitates a fair pricing and reimbursement policy to be in place to create a competitive market for biosimilar medicines.1

Future Outlook

Tearing down the different barriers that hinder access to biosimilars would be beneficial to all stakeholders and would help reduce the financial burdens on healthcare programs across Europe.



1Medicine for Europe Country Specific Market Access Policies. 2018. Rue d’Arlon 50 - 1000 Brussels – Belgium
2Delivering on the Potential of Biosimilar Medicines: The Role of Functioning Competitive Markets. IMS Institute for Healthcare Informatics (2016)
3Challenges and opportunities in improving access to medicines through efficient public procurement in the WHO European Region. (World Health Organization Regional Office for Europe, 2016)
4Forsyth J. Five barriers that could keep biosimilar manufacturers from cracking the US market. Deloitte Center for Health Sciences
5Brill A. Steps to Reducing Barriers to Biosimilars in the United States. September 2018