Today, generic medicines are an integral part of the healthcare system and demand for these products continues to rise. However, while increased usage of generic medicines has led to unprecedented savings for healthcare systems, perspectives often remain focused solely on their cost-saving potential. This can underplay the societal value of generic medicines in Europe and underestimate their contributions, compounding the challenges that healthcare systems are facing today.
Myths to be dispelled on article 85 of the Pharma Directive, so called “Bolar”
Medicines for Europe is committed to improving public health through improved access, availability and affordability of medicines, in line with the pharmaceutical strategy for Europe.
In the context of the new EU pharmaceutical legislation, this document provides an economic analysis of the extension of regulatory data protection periods proposed in the European Parliament, which have strong political support. These extension proposals derive from a misunderstanding about their concrete impact on the cost and access to medicines (see explanation below) due to the complex interplay between the EU pharmaceutical
legislation and other patent and SPC laws.
While biosimilar competition in Europe has played a vital role in achieving significant healthcare savings and expanding patient access to key medicines, the changing nature of future loss of exclusivity (LoE) events means that competition, and by extension savings, is not always guaranteed.
This report provides a timely view of the factors underlying the changing level of biologic pipeline activity in Europe, highlighting classes of biologics that are at risk of failing to attract biosimilar competition, a concept called “the biosimilar void.” This report also aims to quantify the potential impact of the biosimilar void on healthcare system budgets. Drawing on a wide range of IQVIA proprietary data and engagement with individual stakeholders, the report examines the cohort of biologic medicines that will lose protection over the next 10 years. The period for assessment (2023–2032) has been chosen to reflect the average development timeline for new biosimilar candidates (~7-10 years) and intrinsic limitations with forecasting data beyond 2032. Due to the evolving nature of the IP landscape in Europe, legal and IP barriers are not discussed in the present study.
The Biosimilar Market Access Committee (Biosimilar medicines Group, a Medicines for Europe sector group) undertook a 2023 Biosimilar market review consisting of updates on biosimilar medicines policy across Europe (28 European countries).
The highlights of this overview have been consolidated below and illustrate both key challenges and recommendations on how to improve specific policy interventions (e.g. pricing and reimbursement, procurement, prescribing and dispensing) to enhance biosimilar medicines use and competition in the biologics market in Europe.
The purpose of this Market Review is to provide a general overview of the policies that are currently in place for biosimilar medicines in the different European countries allowing the reader to get a clear understanding. The 2023 Market Review covers the following policy areas: Availability of biosimilar medicines, Pricing & Reimbursement systems, Procurement of biosimilar medicines, prescribing & dispensing policies, and information & education policies
Medicines for Europe welcomes the introduction of harmonised labelling, notably regarding recycling symbols which are sometimes already present in national legislations or the blue box – for example, in Bulgaria, France, and Austria.
The proposal, however, also introduces a requirement to provide information on the material composition, as well as information regarding the manufacturer and its contact details. We are concerned by the introduction of that information as there is limited space available on the packaging of pharmaceutical products.