Learnings from Regional Market Dynamics of Originator and Biosimilar Infliximab and Etanercept in Germany.

Drug budget and prescription control measures are implemented regionally in Germany, meaning that the uptake of pharmaceuticals, including biosimilars, can vary by region. We examine regional market dynamics of tumor necrosis factor alpha (TNFα) inhibitor originators and biosimilars in Germany and studied the influence of biosimilar policies on these dynamics. This study is based on: (1) a literature review in which German biosimilar policies are identified, (2) the analysis of dispensing data (2010-2018) for the class of TNFα inhibitors, and (3) ten semi-structured interviews investigating prescribers' and insurers' views on factors potentially influencing biosimilar uptake. The analysis of biosimilar market shares of infliximab and etanercept revealed wide variations across the 17 German Regional Associations of Statutory Health Insurance Accredited Physicians (PA regions). Quantitative analyses indicated that biosimilar market shares for infliximab and etanercept were significantly lower in former East Germany when compared to former West Germany regions. Through qualitative interview analyses, this study showed that the use of infliximab and etanercept biosimilars across Germany is primarily influenced by (1) the regional-level implementation of biosimilar quotas and the presence of monitoring/sanctioning mechanisms to ensure adherence to these quotas, (2) the different insurer-manufacturer discount contracts, and (3) gainsharing arrangements established at the insurer-prescriber level

The market of biopharmaceutical medicines: A snapshot of a diverse industrial landscape

Background: Biopharmaceutical medicines represent a growing share of the global pharmaceutical market, and with many of these biopharmaceutical products facing loss of exclusivity rights, also biosimilars may now enter the biopharmaceutical market. Objectives: This study aims to identify and document which investment and development strategies are adopted by industrial players in the global biopharmaceutical market. Methods: A descriptive analysis was undertaken of the investment and development strategies of the top 25 pharmaceutical companies according to 2015 worldwide prescription drug sales. Strategies were documented by collecting data on manufacturing plans, development programs, acquisition and collaboration agreements, the portfolio and pipeline of biosimilar, originator and next-generation biopharmaceutical products. Data were extracted from publicly available sources. Results: Various investment and development strategies can be identified in the global biopharmaceutical market: (a) development of originator biopharmaceuticals, (b) investment in biotechnology, (c) development of next-generation biopharmaceuticals, (d) development of biosimilars, (e) investment in emerging countries, and (f) collaboration between companies. In the top 25 pharmaceutical companies almost every company invests in originator biopharmaceuticals and in biotechnology in general, but only half of them develops next-generation biopharmaceuticals. Furthermore, only half of them invest in development of biosimilars. The companies' biosimilar pipeline is mainly focused on development of biosimilar monoclonal antibodies and to some extent on biosimilar insulins. A common strategy is collaboration between companies and investment in emerging countries. Conclusions: A snapshot of investment and development strategies used by industrial players in the global biopharmaceutical market shows that all top 25 pharmaceutical companies are engaged in the biopharmaceutical market and that this industrial landscape is diverse. Companies do not focus on a single strategy, but are involved in multiple investment and development strategies. A common strategy to market biopharmaceuticals is collaboration between companies. These collaborations can as well be used to gain access in regions the company has less experience with. With patents expiring for some of the highest selling monoclonal antibodies, this snapshot highlights the interest of companies to invest in the development of these molecules and/or enter into collaborations to create access to these molecules

Predictive modeling of the current density and radiative recombination in blue polymer-based light-emitting diodes

The results of a combined experimental and modeling study of charge transport, recombination and light emission in blue organic light-emitting diodes (OLEDs) based on a polyfluorene derivative are presented. It is shown that the measured temperature-dependent current-voltage curves and the voltage-dependent current efficiency are accurately described using an OLED device model that is based on the separately determined unipolar electron and hole mobility functions. The recombination rate is calculated using the Langevin formula, including recombination of holes with free as well as trapped electrons. The light emission is obtained from the exciton formation profile using independently determined values of the exciton radiative decay probability, the average dipole orientation, and assuming a fraction of singlet excitons ¿S¿¿ = ¿(22±3)%, close to the quantum-statistical value. No additional free parameter is used. This shows that predictive one-dimensional device modeling of OLEDs is feasible

Different Policy Measures and Practices between Swedish Counties Influence Market Dynamics: Part 1Biosimilar and Originator Infliximab in the Hospital Setting

Background Decentralisation of healthcare budgets and issuance of local guidelines means that the use of biosimilars can vary by region within a particular country, for example between the 21 counties of Sweden. Objectives This study aimed to analyse the county-level market dynamics of biosimilar and originator infliximab, which are hospital products, and to examine how local policy measures and practices, in addition to national policy, influenced market dynamics. Methods We first conducted a literature review on (biosimilar) policies in Sweden, then analysed market data provided by IQVIA™ on uptake of originator and biosimilar infliximab within the different counties (Q2 2012 to Q4 2017), including discounts from (tender) contracts. Biosimilar market shares were calculated with volume data (measured as defined daily doses [DDDs]). We then discussed our findings in semi-structured interviews with the national pricing and reimbursement agency, key experts within the county councils of Skåne, Västra Götaland, and Stockholm, and an industry representative. Results Market shares of biosimilar infliximab vary widely between counties (range 18–96% in 2

Different Policy Measures and Practices between Swedish Counties Influence Market Dynamics: Part 2Biosimilar and Originator Etanercept in the Outpatient Setting

Background Diverging approaches towards market entry and uptake of biosimilars, even within a country, leads to regional variation in biosimilar use. This is the case in Sweden, where the 21 county councils control the healthcare budget and ofer regional guidance. Objectives This study aimed to analyse the market dynamics of originator and biosimilar etanercept (outpatient setting) in the diferent counties of Sweden, and examine the infuence of local policy measures and practices, in addition to national policy. Methods This study was performed in three steps: (1) a structured review of the literature on (biosimilar) policies in Sweden; (2) analysis of market data on the counties’ originator and biosimilar etanercept uptake (quarter two 2012 to quarter four 2017) provided by IQVIA™; and (3) discussion of fndings in face-to-face semi-structured interviews with the national pricing and reimbursement agency, key experts in the county councils of Skåne, Västra Götaland and Stockholm, and an industry representative. Results Notwithstanding the existence of a national managed entry agreement for etanercept, wide variations in biosimilar market shares between counties wer

Learnings from Regional Market Dynamics of Originator and Biosimilar Infliximab and Etanercept in Germany

Drug budget and prescription control measures are implemented regionally in Germany, meaning that the uptake of pharmaceuticals, including biosimilars, can vary by region. We examine regional market dynamics of tumor necrosis factor alpha (TNFα) inhibitor originators and biosimilars in Germany and studied the influence of biosimilar policies on these dynamics. This study is based on: (1) a literature review in which German biosimilar policies are identified, (2) the analysis of dispensing data (2010–2018) for the class of TNFα inhibitors, and (3) ten semi-structured interviews investigating prescribers’ and insurers’ views on factors potentially influencing biosimilar uptake. The analysis of biosimilar market shares of infliximab and etanercept revealed wide variation

A Look at the History of Biosimilar Adoption: Characteristics of Early and Late Adopters of Infliximab and Etanercept Biosimilars in Subregions of England, Scotland and Wales - A Mixed Methods Study

Background: Regions within England, Scotland and Wales show variation in rate of adoption of biosimilar infliximab and etanercept. Objectives: This study aims to examine how local decisions and practices in regions within England, Scotland and Wales might explain initial variation in market dynamics of biosimilar and originator infliximab and etanercept. Methods: Market data provided by the National Health Service (NHS) on biosimilar and originator infliximab and etanercept uptake were analysed for the 10 historical regions of England, 14 health boards in Scotland and 7 health boards in Wales (2015–2018). Findings were discussed in ten semi-structured interviews: on a national level with an industry representative (1), on a regional level with NHS employees in England (6), Scotland (1) and Wales (1), and on a local level with a representative of a clinical commissioning group in England (1). Results: Tenders for infliximab and etanercept in England, Scotland and Wales have consistently resulted in a biosimilar as the best value biological. Early and late biosimilar adopters are seen, with overall convergence towards high biosimilar market shares over time. Qualitative results suggest that biosimilar adoption was positively influenced by (a) a price difference between biosimilar and originator product making it worthwhile to switch patients; (b) a good relationship between commissioner and provider in England resulting in gain share agreements; (c) leadership on biosimilars in regional NHS offices in England or Scottish and Welsh health boards; (d) key opinion leaders or leading hospitals that start using biosimilars early and gain experience. Conclusions: This study has shown that the savings potential drives biosimilar use. Regions with a proactive attitude, good stakeholder relationships, and clinician engagement were identified as early adopters