Generic Pharmaceutical Industry Research Articles

Factors influencing the creation of an industry 4.0 strategy in the generic pharmaceutical industry

This study aims to identify how technological, organizational, and environmental factors influence the creation of an Industry 4.0 (I4.0) strategy in the generic pharmaceutical manufacturing industry. In this study, the technology-organization-environment (TOE) framework is used to explore the factors that influence the creation of an I4.0 strategy in generic pharmaceutical manufacturing organizations. A semi-structured interview case study approach was used to gather data from a generic pharmaceutical company using the company’s creation of a digital strategy as the focus of analysis. The study identifies a paradox where Regulatory Compliance serves both as a driving force for I4.0 strategy creation, aligned with stakeholder pressure, and a potential barrier due to complexity and implementation costs. The impact of regulatory changes, such as those in environmental, social, and governance (ESG) reporting, also contributes to the adoption of I4.0 technologies. The importance of organizational executive leader alignment on the broader environmental context and technical benefits for creating an I4.0 strategy is a key driver to overcome the investment barriers and risks that come with I4.0 strategy implementation in the context of a generic pharmaceutical manufacturing organization.

Creating an Assessment Indicator of Quality Culture Development in the Generic Pharmaceutical Industry in Japan.

In the past few years, there have been several instances of illicit pharmaceutical manufacturing in Japan, and there is a growing awareness of the importance of corporate compliance and pharmaceutical manufacturing and quality controls. One cause of illicit manufacturing is the inadequate development of quality culture. This study focuses on the degree of quality culture development in Japanese pharmaceutical companies manufacturing generic drugs. Because no evaluation index for Japan can visualize the degree of quality culture development in each company, this study sought to establish this index to utilize it as a tool for evaluating the degree of quality culture development that would enable each company to continuously monitor and improve its own. We conducted a questionnaire survey among Japan Generic Medicines Association members to evaluate the degree of their quality culture development. The questionnaire contained 28 questions in five evaluation categories. Potential indicators of quality culture development included "Employee growth and satisfaction"; "Management commitment"; "Improvement activities"; "Communication"; and "Environment, health, and safety." We obtained 294 responses from 37 Marketing Authorization Holder (MAH) and 61 manufacturing sites. Respondents were classified by roles of management, manager, and nonmanager. The results confirmed the current status of quality culture development efforts, showing that important messages such as the corporate philosophy as communicated by the management is well known, awareness of quality culture development level differs by role, and appropriate resources are not adequately allocated to employees or facilities. Based on the results, use of the index of quality culture development helped to make relative comparisons and visualize the areas to be addressed for quality culture development. This study established and visualized the index for the degree of quality culture development in domestic generic drug manufacturing companies and we hope this indicator becomes a useful tool for evaluating a company's quality culture development level.

Manufacturing and Regulatory Barriers to Generic Drug Competition: A Structural Model Approach

Understanding the drivers of market concentration in the generic pharmaceutical industry is essential to guaranteeing the availability of low-cost generics. In this paper, we develop a structural model to capture the multiple determinants governing manufacturers’ entry decisions; in particular, we focus on how manufacturing complexity and the regulatory environment for generics approval affect concentration in drug markets. We estimate the model using data collated from six disparate sources. We find that manufacturing complexity, as reflected in the number of active ingredients, for example, significantly reduces the likelihood of generics entry. Moreover, the delay in the review process for the generics applications significantly affects the number of firms entering a market. Our policy simulations suggest that a shortened drug approval review time significantly increases the average number of entrants per market and reduces the fraction of markets with no generics entry; however, a notable portion of markets would still lack any generic competition. This paper was accepted by Jayashankar Swaminathan, operations management. Supplemental Material: The online appendix is available at https://doi.org/10.1287/mnsc.2022.4423 .

Generics and Biosimilars: Barriers and Opportunities

Generics and Biosimilars: Barriers and Opportunities

Co-Crystals for Generic Pharmaceuticals: An Outlook on Solid Oral Dosage Formulations.

Co-crystal is an attractive alternative and a new class of solid forms because that can be engineered to have desired physicochemical properties. Co-crystals have gained considerable attention from the generic pharmaceutical industry after the USFDA released its finalized guidlines in the year 2018 on the regulatory classification of co-crystals. In this review, we discussed how co-crystals could be explored as a potential alternative solid form for the development of a generic product that meets the legal, regulatory, and bioequivalence requirements. In the contents, we discussed in detail concepts such as the selection of coformers, various ways of making co-crystals, the strategy of characterization to discriminate between co-crystal and salt, polymorphism in co-crystals, the aspects of intellectual property and, finally, the regulatory aspects of co-crystals.

Thoughts and suggestions on registration and classification of traditional Chinese medicines

In this paper, we reviewed the history of the registration and classification changes of traditional Chinese medicines(TCM) since the establishment of China's drug regulatory agency, and put forward relevant suggestions. Although China's drug regulatory agency has gone through 22 years, the whole regulatory system was gradually built on the basis of the generic pharmaceutical industry at that time and through continuous exploration and summary of simply experience from foreign regulatory agencies. To a certain extent, the supervision of TCM drugs was also affected by some immature supervision ideas during this period. Based on the newly issued Drug Administration Law and Provisions for Drug Registration, the author puts forward some personal thoughts on the classifications of TCM drug registration. It is hoped that experts in the industry and regulatory agencies will work together to explore and improve the relevant system of TCM registration administration.

Commentary on the Benefits of US Pharmacopeial Standards: A Generic Pharmaceutical Industry Survey

Pharmacopeial quality standards for medicines are associated with ensuring quality, but they can also facilitate innovation and competition in pharmaceutical markets. Unpublished data suggest that pharmacopeial quality standards, while not associated with increasing the likelihood of a first generic entrant in the market, are associated with increasing the overall number of generic entrants. This commentary describes an online survey of finished-dose generic drug manufacturers in the United States and India that explores whether using pharmacopeial documentary standards and physical reference standards (RSs) such as those developed by the US Pharmacopeial Convention, accelerate generic drug development and reduce the duration, cost, and risk involved in bringing generic drugs to the US market. The survey provides new evidence that using pharmacopeial documentary standards and physical RSs (1) saves generic drug companies 19% of the time spent on generic product development overall and 31% of time spent on analytical method development and (2) provides clear guidance on quality, thereby reducing the perceived risk of Abbreviated New Drug Application rejection by the US Food and Drug Administration. Ninety percent of respondents agreed that the use of pharmacopeial documentary standards accelerated product development compared with 85% for physical RSs; and 92% of respondents agreed that the use of documentary standards and physical RSs reduced the risk that their Abbreviated New Drug Application would be rejected. Owing to the relatively small sample size of the survey, the results should be viewed as entirely directional for use in trends analysis on the finished-dose generic pharmaceutical industry. The margin of error for all results is 8%-14% at a 95% confidence interval.

A descriptive cross-sectional study to evaluate the Generic Drug User Fee Act: A boon or loss to the Indian generic pharmaceutical industry

A descriptive cross-sectional study to evaluate the Generic Drug User Fee Act: A boon or loss to the Indian generic pharmaceutical industry

Synthesis and characterization of potential impurities of Vigabatrin-An anti epileptic drug

The present work describes the synthesis and characterization of four potential impurities of Vigabatrin (1) namely 2-(2-aminobut-3-enyl)malonic acid (2) (Vigabatrin USP impurity-E), 2-(2-oxo-5-vinylpyrrolidin-1-yl)acetic acid (3) (USP Tablets impurity), 4-aminohexanoic acid (4) and 2,2′-oxo-5,5′-bispyrrolidinyl ether (5). Compound 4 is a possible process related impurity of 1 where as compound 5 is a process related impurity of 5-ethoxy-2-pyrrolinone (16). All these impurities have a significant impact on the quality of the drug product. This work is extremely useful for generic pharmaceutical industry.

Manufacturing and Regulatory Barriers to Generic Drug Competition: A Structural Model Approach

Understanding the drivers of market concentration in the generic pharmaceutical industry is essential to guaranteeing the availability of low-cost generics. In this paper, we develop a structural model to capture the multiple determinants governing manufacturers' entry decisions; in particular, we focus on how manufacturing complexity and the regulatory environment for generics approval affect concentration in drug markets. We estimate the model using data collated from six disparate sources. We find that manufacturing complexity, as reflected in the number of active ingredients, for example, significantly reduces the likelihood of generics entry. Moreover, the delay in the review process for the generics applications significantly affects the number of firms entering a market. Our policy simulations suggest that a shortened drug approval review time significantly increases the average number of entrants per market and reduces the fraction of markets with no generics entry; however, a notable portion of markets would still lack any generic competition.

The SPC manufacturing waiver: Good for patients, good for jobs, good for Europe

The European Commission is currently considering an important legislative proposal which is supported by the generic pharmaceutical industry. Following the introduction of supplementary protection certificates in the 1990s, an unintended consequence has been felt by European generic manufacturers, whom are very often the last group to be able to commence commercial production, due to earlier expiry of rights in other parts of the world. This puts European pharmaceutical manufacturers at a competitive disadvantage, seeing as they are not able to manufacture product for export to countries in which no patent rights exist, or in readiness for day 1 launches in Europe. The supplementary protection certificate manufacturing waiver has been independently assessed to represent €7.3–9.5b of revenue to European industry by 2025, to generate 20,000–25,000 jobs, to lead to €1.6–3.1b in healthcare cost-savings and to improve patient access to healthcare. However, the European Federation of Pharmaceutical Industries and Associations (EFPIA) and other innovator pharmaceutical groups have been lobbying against the proposal. In this paper, I examine the arguments against the supplementary protection certificate manufacturing waiver, particularly those set out in EFPIA’s White Paper that was published in 2017. The conclusions of the White Paper are found to be unsupported. It is hoped that the supplementary protection certificate manufacturing waiver will be implemented, and provide a valuable stimulus for the manufacture of pharmaceuticals in Europe.

Availability and affordability of blood pressure-lowering medicines and the effect on blood pressure control in high-income, middle-income, and low-income countries: an analysis of the PURE study data

Hypertension is considered the most important risk factor for cardiovascular diseases, but its control is poor worldwide. We aimed to assess the availability and affordability of blood pressure-lowering medicines, and the association with use of these medicines and blood pressure control in countries at varying levels of economic development. We analysed the availability, costs, and affordability of blood pressure-lowering medicines with data recorded from 626 communities in 20 countries participating in the Prospective Urban Rural Epidemiological (PURE) study. Medicines were considered available if they were present in the local pharmacy when surveyed, and affordable if their combined cost was less than 20% of the households' capacity to pay. We related information about availability and affordability to use of these medicines and blood pressure control with multilevel mixed-effects logistic regression models, and compared results for high-income, upper-middle-income, lower-middle-income, and low-income countries. Data for India are presented separately because it has a large generic pharmaceutical industry and a higher availability of medicines than other countries at the same economic level. The availability of two or more classes of blood pressure-lowering drugs was lower in low-income and middle-income countries (except for India) than in high-income countries. The proportion of communities with four drug classes available was 94% in high-income countries (108 of 115 communities), 76% in India (68 of 90), 71% in upper-middle-income countries (90 of 126), 47% in lower-middle-income countries (107 of 227), and 13% in low-income countries (nine of 68). The proportion of households unable to afford two blood pressure-lowering medicines was 31% in low-income countries (1069 of 3479 households), 9% in middle-income countries (5602 of 65 471), and less than 1% in high-income countries (44 of 10 880). Participants with known hypertension in communities that had all four drug classes available were more likely to use at least one blood pressure-lowering medicine (adjusted odds ratio [OR] 2·23, 95% CI 1·59-3·12); p<0·0001), combination therapy (1·53, 1·13-2·07; p=0·054), and have their blood pressure controlled (2·06, 1·69-2·50; p<0·0001) than were those in communities where blood pressure-lowering medicines were not available. Participants with known hypertension from households able to afford four blood pressure-lowering drug classes were more likely to use at least one blood pressure-lowering medicine (adjusted OR 1·42, 95% CI 1·25-1·62; p<0·0001), combination therapy (1·26, 1·08-1·47; p=0·0038), and have their blood pressure controlled (1·13, 1·00-1·28; p=0·0562) than were those unable to afford the medicines. A large proportion of communities in low-income and middle-income countries do not have access to more than one blood pressure-lowering medicine and, when available, they are often not affordable. These factors are associated with poor blood pressure control. Ensuring access to affordable blood pressure-lowering medicines is essential for control of hypertension in low-income and middle-income countries. Population Health Research Institute, the Canadian Institutes of Health Research, Heart and Stroke Foundation of Ontario, Canadian Institutes of Health Research Strategy for Patient Oriented Research through the Ontario SPOR Support Unit, the Ontario Ministry of Health and Long-Term Care, pharmaceutical companies (with major contributions from AstraZeneca [Canada], Sanofi Aventis [France and Canada], Boehringer Ingelheim [Germany amd Canada], Servier, and GlaxoSmithKline), Novartis and King Pharma, and national or local organisations in participating countries.

New Product Development in the Pharmaceutical Industry: Evidence from Iran

In today’s competitive world, there are several strategies to deal with the fast changing environment, among which New product development (NPD) is a common strategy. However, almost half of the resources that companies devote to NPD are spent on products that may fail. This issue is particularly highlighted in the pharmaceutical industry mainly because of a long development-time, low success rate, high capital requirement, and market uncertainty in. This study identifies critical success factors of NPD based on the relevant literatures and expert opinions in Iranian pharmaceutical industry, then prioritizes them using the methodology of multiple criteria decision making (MCDM) through analyzing 50 filled questionnaires which is structured based on the AHP (Analytical Hierarchy Process) approach. Although the NPD success factors seem same in both generic and bio-generic pharmaceutical industries, the underlying factors and related sub-factors show the different importance in these two industries. However, this study reveal that, the company capabilities is the most important factor affecting new product development success in both pharmaceutical generic and bio-generic industry. The results of this study contribute to create baseline information for pharmaceutical industry especially Iranian pharmaceutical companies to be more effective in budget allocation on improving NPD success factors so that they can boost the success rate of NPD more effectively.

The Dynamic Spillovers of Entry: An Application to the Generic Drug Industry

This paper examines whether experience from entry in one market can potentially enhance profitability at a future market opportunity for a related product. We formulate and estimate a dynamic game of entry in which forward-looking firms make decisions not just based on present benefits of past entry but also anticipating potential future benefits of current entry. Dynamic spillovers of entry are incorporated through a firm-specific unobservable (to the researcher) cost that depends on past entry decisions. The unobserved costs may also be serially persistent. Thus, the model allows for firm-specific unobserved heterogeneity that evolves based on firm actions. The challenge of estimating a dynamic game with serially correlated unobserved state variables subject to endogenous feedback is overcome by embedding a particle filter-based technique in a nested fixed-point algorithm. Using an application to a stylized model of entry in the generic pharmaceutical industry, we underscore the motivation for the model specification and the methodology developed. Our estimates imply positive spillover effects of entry. Moreover, these spillovers suggest heterogeneity not just across firms but also within firms over time based on their history of entry decisions. Our results illustrate that entry may potentially provide firms with additional strategic advantage in later markets and that entry spillovers may be an important factor to consider in the equilibrium evolution of the generic drug industry.The web appendix is available at https://doi.org/10.1287/mnsc.2016.2648 .This paper was accepted by J. Miguel Villas-Boas, marketing.

Pharmaceutical innovation and market share: evidence from a generic market

Purpose Pharmaceutical market value in Iran exceeded to more than US$4bn in 2013, indicating annually over 20 per cent growth. In the past decades, Iranian pharmaceutical industry was supported by government policies, namely, generic substitution, import limitation and local production support; however, the local pharmaceutical manufacturer’s market share in value has been decreased gradually. This study aims to provide historical data on Iran pharmaceutical market to show the importance of new product development to attain greater market share and tries to motivate the pharmaceutical industry located in developing countries to develop more innovative medicines. Design/methodology/approach This is a descriptive cross-sectional study that investigates the Iranian pharmaceutical market by focusing on new products over a five-year period (2009-2014), and that was augmented by an expert panel to rank subjectively firms’ performance indicators to shed light on the importance of new product development to firms’ performance. Findings The expert panel results find out that new product development is one of the most important “result indicators” for Iranian pharmaceutical companies. Historically, in line with the experts’ opinion on the new product development, the Iranian pharmaceutical industry has shown its capability to develop new medicines by developing 3,095 new products (mostly new-to-firm) across about 100 firms. Despite this fact, the share of local manufacturers in new medicines’ market decreased from 52 per cent at the beginning of studied period to 24 per cent at the end, and the gap between the unit value of imported and domestically produced medicines has been significantly increased due to low-innovative medicines locally produced. Research limitations/implications This research was challenged with limitations such as lack of reliable published data on new medicines in the Iran pharmaceutical market. Practical implications This study highlights the fact that developing more innovative products in the generic pharmaceutical industry such as Iran can grant its market share. Originality/value This is an original study that shows the effect of innovative product development on market share through historical data.

Desenvolvimento de Biossimilares no Brasil

Este artigo apresenta uma breve visão do advento da indústria de biossimilares no Brasil e no mundo. Os biossimilares são medicamentos originários de proteínas terapêuticas ou biológicas, cujas patentes estão expiradas ou em expiração. Analogamente à indústria farmacêutica de genéricos, a expiração das patentes dos medicamentos biológicos condiciona o surgimento de um novo segmento na indústria farmacêutica. Seu advento enseja a transposição de inúmeras barreiras, não somente regulatórias, de propriedade intelectual, bem como de processos e domínio da expertise tecnológica. Esse nível de complexidade impõe às novas empresas que assumam a produção de biossimilares, o mesmo patamar estratégico das empresas originadoras ou detentoras das patentes. A importância dos biossimilares se deve no contexto de saúde pública, aos altos custos dos biológicos originadores. Como a incidência de doenças crônico-degenerativas dominará o cenário dos sistemas de saúde, devido ao envelhecimento da população, a emergência dos biossimilares acarretará reduções substanciais de custos.

Sun Pharma gets U.S. subpoena

The Indian generic drug maker Sun Pharmaceutical Industries is the latest drug company to receive an inquiry on pricing from U.S. authorities. Sun Pharma says its U.S. subsidiary received a grand jury subpoena from the Department of Justice’s antitrust division seeking information on generic drug pricing and communications with competitors and others on the sale of generics. The probe comes as Congress is pressuring regulators to investigate rising generic drug prices. Other generic drug makers including Dr. Reddy’s Laboratories, Allergan, and Par Pharmaceutical received subpoenas last year.

Continuous improvement concepts as a link between quality assurance and implementation of cleaner production: Case study in the generic pharmaceutical industry

The subject and the research objective presented in this article is establishing of the relationship between quality assurance and implementation of cleaner production in the generic pharmaceutical industry through the comprehensive concept of continuous improvement. This is mostly related to application of Lean and Six Sigma tools and techniques for process improvement and their link to other known concepts used in the industrial environment, especially manufacturing of generic pharmaceutical products from which two representative case studies were selected for comparative analysis, also considering relevant regulatory requirements in the field of quality management, as well as appropriate quality standards. Although the methodology discussed in this conceptual and practice oriented article is strongly related to chemical engineering, the focus is mainly on process industry, i.e. production systems, rather than any specific technological process itself. The scope of this research is an engineering approach to evaluation of the production systems in terms of continuous improvement concepts application, considering both quality aspects and efficiency of such systems.

Availability and affordability of cardiovascular disease medicines and their effect on use in high-income, middle-income, and low-income countries: an analysis of the PURE study data

WHO has targeted that medicines to prevent recurrent cardiovascular disease be available in 80% of communities and used by 50% of eligible individuals by 2025. We have previously reported that use of these medicines is very low, but now aim to assess how such low use relates to their lack of availability or poor affordability. We analysed information about availability and costs of cardiovascular disease medicines (aspirin, β blockers, angiotensin-converting enzyme inhibitors, and statins) in pharmacies gathered from 596 communities in 18 countries participating in the Prospective Urban Rural Epidemiology (PURE) study. Medicines were considered available if present at the pharmacy when surveyed, and affordable if their combined cost was less than 20% of household capacity-to-pay. We compared results from high-income, upper middle-income, lower middle-income, and low-income countries. Data from India were presented separately given its large, generic pharmaceutical industry. Communities were recruited between Jan 1, 2003, and Dec 31, 2013. All four cardiovascular disease medicines were available in 61 (95%) of 64 urban and 27 (90%) of 30 rural communities in high-income countries, 53 (80%) of 66 urban and 43 (73%) of 59 rural communities in upper middle-income countries, 69 (62%) of 111 urban and 42 (37%) of 114 rural communities in lower middle-income countries, eight (25%) of 32 urban and one (3%) of 30 rural communities in low-income countries (excluding India), and 34 (89%) of 38 urban and 42 (81%) of 52 rural communities in India. The four cardiovascular disease medicines were potentially unaffordable for 0·14% of households in high-income countries (14 of 9934 households), 25% of upper middle-income countries (6299 of 24,776), 33% of lower middle-income countries (13,253 of 40,023), 60% of low-income countries (excluding India; 1976 of 3312), and 59% households in India (9939 of 16,874). In low-income and middle-income countries, patients with previous cardiovascular disease were less likely to use all four medicines if fewer than four were available (odds ratio [OR] 0·16, 95% CI 0·04-0·57). In communities in which all four medicines were available, patients were less likely to use medicines if the household potentially could not afford them (0·16, 0·04-0·55). Secondary prevention medicines are unavailable and unaffordable for a large proportion of communities and households in upper middle-income, lower middle-income, and low-income countries, which have very low use of these medicines. Improvements to the availability and affordability of key medicines is likely to enhance their use and help towards achieving WHO's targets of 50% use of key medicines by 2025. Population Health Research Institute, the Canadian Institutes of Health Research, Heart and Stroke Foundation of Ontario, AstraZeneca (Canada), Sanofi-Aventis (France and Canada), Boehringer Ingelheim (Germany and Canada), Servier, GlaxoSmithKline, Novartis, King Pharma, and national or local organisations in participating countries.

The refinement of the super generic concept: semantic challenge for product re-innovation?

Background: Uptake of super generic or hybrid pharmaceuticals has decelerated despite their important economic potential for the generic pharmaceutical industry. The aim of switching to these product portfolios was to enable product differentiation; however, these strategies are influenced by new semantic challenges,