Abstract of Dissertation

Agency : Biosimilars, Eduropean Nations, Pharmaceutical Market, Biologic Medical Products

Objective : To identify the major biosimilars in market contributing to the economy of pharmaceutical industry in Europe and analyze the uptake of each across different geographies.

Methodology : Method of analysis included studying the trends, horizontal and vertical analysis through secondary research using URL’S, websites, journals, databases from the organization etc. The study also analyses the reasons for the increased or decreased uptake across geographies. It will also focus on the pricing pattern and the perception of the payers for the biosimilars. EMA (European Medicines Agency) is the main regulatory body for Europe still the differences in uptake are prominent. Results of the data analyzed show the differences among the nations with variations across geographies and therapeutic areas. The highest uptake areas for respective biosimilars are highlighted in the study for e.g. biosimilar Filgrastim shows highest uptake in UK; however it is not the overall best market in Europe for biosimilars. The report focuses on the current trends of biosimilars in the market. It also talks about the drivers and barriers for the uptakes and how to overcome them so as to increase the sales of biosimilars in these geographies and make strategies or plan for the clients dealing with biosimilars. As mentioned above the biologic drugs are very expensive drugs, which are out of the reach of the common man, and they are used mainly for treatment of cancers, where the overall cost of treatment goes very high. Biosimilars are comparatively cheaper versions of the original or reference biotherapeutic product, but the cost reduction is not very high as the manufacturing and storage cost is very high. Maximum reduction in cost could be 20-30%. Therefore it also assesses the out of pocket expenditure and how much the population is insured making biosimilars accessible to them. The organization is a consultancy firm with expertise and focus on sales and marketing, so the recommendations were focused mainly on improving the sales of these drugs into the market with the study of existing competitors for the same. These could be like increasing the quota systems, tendering etc.

Findings : • Germany was found to be the most favourable for biosimilars due to its reimbursement policies. The country has a biosimilar reference pricing policy, plus targets or quotas for biosimilars use for physicians and sickness funds • The UK was also found to be favourable, with its buoyant generics market and cost-effectiveness analyses of biosimilars by the UK’s National Institute for Health and Care Excellence (NICE) • France was also found to be a potentially favourable market for biosimilars. Although the country also has a strict price regulation system and compulsory discounts for biosimilars, high volume sales of biologicals compared to other EU countries add to the attractiveness of the market for biosimilars 77 • Italy was found to be the least favourable country for biosimilars due to its strict price regulation system which requires a mandatory discount of 15–22% for biosimilars relative to that of the brand-name reference product • Biosimilars are classified in Spain as HOM (hospital only medicine), meaning that they are only dispensed to outpatients attending hospitals, which could offer one explanation for the low uptake of biosimilars in Spain

Recommendations : As per the findings Germany is the best market for biosimilars while Spain and Italy are the last. The study suggests that Germany holds the best market because of biosimilar reference pricing policy, plus targets or quotas for biosimilars use for physicians and sickness funds. Therefore to improve the market of biosimilars in Spain and Italy similar policies should be followed. On the other hand for the biosimilars having safety concerns various education programs should be run for the physicians or payers to build trust. Not only this, the out of pocket expenditure should be reduced. This can be done either by giving expected discounts on biosimilars, so that payers put them in their reimbursement panel for e.g. Italy expects discounts of 40% of the original brand price for some biosimilars (in hospitals) while Spain expects biosimilars with approximately 30-40% the price of the branded drug.

Introduction and Background: Biosimilars are the emerging trends in pharmaceutical market across the globe. They are the biologic medical products whose active drug substance is made by a living organism or derived from a living organism by means of recombinant DNA or controlled gene expression methods. The reference or biologic drugs are highly expensive and beyond the reach of a common man. Therefore biosimilars are gaining popularity in the market of medicine. They are similar to the reference products but cheaper due to less extensive approval pathway. They can be called “Biologics to biosimilars as “Branded to generics”. This report provides an analysis and evaluation of the current and emerging trends of biosimilars in European nation. It focuses on performance of biosimilars across five main geographies in Europe i.e. EU5 nations (Germany, France, UK, Spain and Italy), based on the uptake across geographies and also based on the therapeutic areas.