Sharpen Your Sword: The Reaction of Branded Pharmaceutical Firms to the Threat of Generic Entry

2021 ◽  
Author(s):  
Annamaria Conti ◽  
Leonardo Ortega ◽  
Elie Sung



2017 ◽  
Vol 6 (2) ◽  
pp. 1
Author(s):  
Albert Naiem Naguib ◽  
Eahab Elsaid ◽  
Abdel Moneim Elsaid

This study examines the relationship between dynamic capabilities (experience, routine, skills, firm characteristics, knowledge and technology) and competitive advantage sustainability in the Egyptian pharmaceutical sector. The data was collected using primary and secondary data sources. Primary data was collected from questionnaires distributed to 160 top managers in 20 pharmaceutical firms. The secondary data about pharmaceutical firms like rankings, revenues and market share was collected from external sources such as Intercontinental Marketing Service (IMS). The questionnaires examine six independent variables based on a five-scale Likert scale. The methodology used in the study is non-probability sampling (judgmental sampling), Cronbach’s alpha reliability coefficient and Chi-square tests. The results support the notion that there is a significant relationship between four of the six dynamic capabilities (experience, skills, firm characteristics and knowledge) and the competitive advantage sustainability for pharmaceutical firms in Egypt. Designing the questionnaire and formulating the questions to target the required field was challenging, given that the topic is dynamic and the business scene in Egypt has witnessed drastic political changes since January 2011. The study should assist pharmaceutical companies in Egypt in directing their investments properly and in determining the weaknesses in their dynamic capabilities that need to be addressed.



2021 ◽  
pp. 097215092199305
Author(s):  
Pinku Paul

Profitability is used as a prime indicator to measure the sustainable performance of an organization. The current study made an attempt to apply the DuPont model to investigate the multilevel profitability determinants for the pharmaceutical industry of India. The study also estimates an empirical model to predict the association of profitability with factors such as profit margin, asset utilization, leverage, interest load and tax load of firms in the pharmaceutical industry of India. For this purpose, a dataset for 170 companies from 2010–2011 to 2018–2019 was analysed initially by using panel data regression followed by stepwise panel data regression. The study successfully applied and tested the DuPont model with respect to the firms of the pharmaceutical industry in India. It was found that the factors such as profit margin, asset utilization and leverage had a significant positive effect on the firms’ profitability and the factor interest load had a significant negative effect on the firms’ profitability. The tax load does not have an impact on the profitability of the pharmaceutical firms in India. These findings are expected to provide a guide for understanding the profitability of the firms in a better way.



Author(s):  
Babak Sahragardjoonegani ◽  
Reed F. Beall ◽  
Aaron S. Kesselheim ◽  
Aidan Hollis

Abstract Background Drug repurposing (i.e., finding novel uses for existing drugs) is essential for maximizing medicines’ therapeutic utility, but obtaining regulatory approval for new indications is costly. Policymakers have therefore created temporary indication-specific market exclusivities to incentivize drug innovators to run new clinical investigations. The effectiveness of these exclusivities is poorly understood. Objective To determine whether generic entry impacts the probability of new indication additions. Methods For a cohort of all new small-molecule drugs approved by the FDA between July 1997 and May 2020, we tracked new indications added for the subset of drugs that experienced generic entry during the observation period and then analyzed how the probability of a new indication changed with the number of years since/to generic entry. Results Of the 197 new drugs that subsequently experienced generic entry, only 64 (32%) had at least one new indication added. The probability of a new indication addition peaked above 4% between 7 and 8 years prior to generic entry and then to dropped to near zero 15 years after FDA approval. We show that the limited duration of exclusivity reduces the number of secondary indications significantly. Conclusion Status quo for most drug innovators is creating novel one-indication products. Despite indication-specific exclusivities, the imminence of generic entry still has a detectable impact on reducing the chances of new indication additions. There is much room for improvement when it comes to incentivizing clinical investigations for new uses and unlocking existing medicines’ full therapeutic potential.



Healthcare ◽  
2021 ◽  
Vol 9 (2) ◽  
pp. 194
Author(s):  
Minghui Yang ◽  
Qian Lin ◽  
Petra Maresova

Sustainability of the workforce becomes a crucial issue, of which responsible care for employees can increase job satisfaction and human capital that impact corporate ability to absorb and generate new knowledge. Firms are obligated to provide a healthy and safe working environment for their employees, but it may in turn hinder innovation due to rigid and structured institutional regulations. Drawing on data of 308 China’s pharmaceutical firms from 2010 to 2017, we investigated whether employee care can trigger innovation under corporate adoption of the occupational health and safety management system (OHSMS). Our results suggest that both employee care and OHSMS adoption have a positive impact on innovation. Moreover, the positive relationship between employee care and innovation was more pronounced in firms that had adopted the OHSMS certification. These findings are valuable to policymakers and corporate managers in emerging economies through corroborating the important role of workforce sustainability in facilitating firm innovation.



Author(s):  
Joshua Krieger ◽  
Danielle Li ◽  
Dimitris Papanikolaou

Abstract We provide evidence that risk aversion leads pharmaceutical firms to underinvest in radical innovation. We introduce a new measure of drug novelty based on chemical similarity and show that firms face a risk-reward trade-off: novel drug candidates are less likely to obtain FDA approval but are based on more valuable patents. Consistent with a simple model of costly external finance, we show that a positive shock to firms’ net worth leads firms to develop more novel drugs. This suggests that even large firms may behave as though they are risk averse, reducing their willingness to investment in potentially valuable radical innovation.



2021 ◽  
pp. 097172182110056
Author(s):  
Keungoui Kim ◽  
Junseok Hwang ◽  
Sungdo Jung ◽  
Eungdo Kim

Due to high uncertainty of product development and business environment, firm-level diversification has been regarded as one of the most effective methods in pharmaceutical firms. In previous study, firm-level diversification was discussed by different value chains of market, product, and technology. However, in most cases, the diversification itself was adopted in a simple manner although its property contains different aspects and the results varies depending on the diversity property of selected index. In addition, the existing approach for measuring firm’s product/market diversification using sales information distinguished by standard industry classification cannot provide direct implication as different strategies are made for market and product diversification. Therefore, this study examines the effects of firm-level diversification on business and innovation performances in pharmaceutical firms by considering (1) three diversification types: market, product, and technology, (2) clear separation between market and product diversification, and (3) two diversification perspectives: balance-centred and hetero-centred. For empirical analysis, an integrated firm-level data set combining from Medtrack, Orange Book, Compustat and Total Patent database is used. From the result, in case of market diversification, less market heterogeneity causes significant influence on business performance. For product and technology, a concentrated and greater heterogeneity of product diversification are turned out to promote business performance, while the more intensive and heterogeneous technology diversification has been shown to improve innovation performance.



2020 ◽  
pp. 1-22
Author(s):  
Wolney da Cunha SOARES JÚNIOR

Many governments have implemented a controlled off-label use of medicines as a tool combined with reimbursement decisions, among other policies, to avoid pharmaceutical firms gaming regulatory systems based on the requirement for marketing authorisation. This article aims to compare the drug regulations in selected European Union countries (France, Italy and Germany) in order to identify specific provisions and concrete solutions implemented by them regarding that matter. The employment of an economic analysis of the law as a theoretical framework allows for the identification of the incentives created in the long run by the referred regulations. The scholarly literature identifies a myriad of drawbacks and advantages associated with off-label practices, and a welfare analysis is ambiguous. Off-label practices are a reality; thus, it is advisable to elaborate policy measures in order to address these practices and condition them on some requirements, taking into account that off-label practices imply trade-offs among access to healthcare, protection of public health, competitiveness and innovation in the industry.



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