Generics Industry Research Articles

Captive Generics: The Wolf in Sheep's Clothing

In a first-of-its kind look at the generics industry, this article demonstrates that the generic industry itself is not what it appears. Quite simply, many generic drugs are not true competitors in the market, but rather, are produced or licensed by the brand company. Although known in the industry as “authorized generics,” this article will refer to them as “captive generics,” given that these drugs are subject to the interests and direction of the brand drug company. Rather than a gift to consumers, captive generics operate to elevate prices and reduce competition, undermining the entire structure of the Hatch-Waxman system. This article contains a detailed analysis of 373 different drug markets indicating several alarming features of markets that host a captive generic: • Captive Generics More than Triple the Growth of Brand Prices: The increase of brand net prices once generics entered the market was three-and-a-half times greater in drug markets with a captive generic (21%) compared to drug markets without one (6%). • Captive Generics Boost the Growth of True Generic Prices: The presence of a captive generic caused the price of true generics to increase 11% more during their first year on the market. • Captive Generics Reduce True Generic Market Share: True generics hold 22% less of the market if captive generic enters. • Captive Generics Better Permeate Markets: Compared to the average true generic, a captive generic is able to occupy a 6% larger market share on average. • Captive Generics Do Not Increase the Total Number of Generics: Rather, there tends to be one fewer true generic option when a captive generic is present. • Captive Generics Contribute to Irrational Formulary Tier Placement of True Generics: Given that brand drugs are so much more expensive than generics, it would be irrational to place the brand and generic version of a drug on the same health plan reimbursement tier. The proportion of true generics located in the same formulary tier as the brand drug averaged 12% higher where a captive generic was available than in markets where one wasn’t available. The article proceeds as follows. Part I outlines the rise of captive generics and places them in the context of the Hatch-Waxman system, describing how they disrupt the incentive structure designed to promote generic entry. Part II explains how brand drug-makers use captive generics to induce delayed generic entry through pay-for-delay deals and other collusive arrangements. Part III offers an extensive analysis of 373 distinct drug markets to examine how the entrance of captive generics impacts prices and generic market share. Part IV, responding to these findings, outlines prospective regulatory, legislative and judicial actions to check the harm of captive generics on patients and payors.

A physiologically-based nanocarrier biopharmaceutics model to reverse-engineer the in vivo drug release

Over the years, a wide variety of nanomedicines has entered global markets, providing a blueprint for the emerging generics industry. They are characterized by a unique pharmacokinetic behavior difficult to explain with conventional methods. In the present approach a physiologically-based nanocarrier biopharmaceutics model has been developed. Providing a compartmental framework of the distribution and elimination of nanocarrier delivery systems, this model was applied to human clinical data of the drug products Doxil®, Myocet®, and AmBisome® as well as to the formulation prototypes Foslip® and NanoBB-1-Dox. A parameter optimization by differential evolution led to an accurate representation of the human data (AAFE < 2). For each formulation, separate half-lives for the carrier and the free drug as well as the drug release were calculated from the total drug concentration-time profile. In this context, a static in vitro set-up and the dynamic in vivo situation with a continuous infusion and accumulation of the carrier were simulated. For Doxil®, a total drug release ranging from 0.01 to 22.1% was determined. With the time of release exceeding the elimination time of the carrier, the major fraction was available for drug targeting. NanoBB-1-Dox released 76.2–77.8% of the drug into the plasma, leading to an accumulated fraction of approximately 20%. The mean residence time of encapsulated doxorubicin was 128 h for Doxil® and 0.784 h for NanoBB-1-Dox, giving the stealth liposomes more time to accumulate at the intended target site. For all other formulations, Myocet®, AmBisome®, and Foslip®, the major fraction of the dose was released into the blood plasma without being available for targeted delivery.

It is time to change US trade policy to foster access to medicines

While Americans are deeply concerned about drug prices, the United States Trade Representative (USTR) continues to negotiate agreements like the United States-Mexico-Canada Agreement (USMCA) that put at risk the sustainability of the generics industry and undermine the development of biosimilars that play a critical role in access to medicines. It is time to restore some balance to US trade policy.

Brand-name biologic drugs protected by USMCA

The U.S.-Mexico-Canada Agreement (USMCA) on trade, announced Oct. 1, will protect brand-name biologic drugs for at least 10 years after their approval in all three countries. In the U.S., biologics are already protected for 12 years under an amendment to the Patient Protection & Affordable Care Act. The Pharmaceutical Research & Manufacturers of America, the drug industry’s trade association, praised the new pact; the agreement strengthens “critical intellectual property (IP) protections and other standards that will pave the way for the next generation of treatments and cures,” CEO Stephen J. Ubl said. The Biotechnology Innovation Organization, which represents the biotech industry, also endorsed the deal. But U.S. and Canadian generic-drug trade associations oppose the agreement, saying it will raise prescription drug prices for patients. The Association for Accessible Medicines, the U.S. generics industry group, said in a statement that the proposed provisions “do not adequately balance innovation with access to

Unintended Consequences: How Introducing a Manufacturing and Export Exemption to Supplementary Protection Certificates Would Weaken Global Standards of IP Protection and Result in Direct Losses to Europe's Research-Based Biopharmaceutical Industry

Background: In October 2015 the European Commission (EC) released its report Upgrading the Single Market: More Opportunities for People and Business, which includes a stated intention to explore an option for implementing a Supplementary Protection Certificate (SPC) manufacturing and export exemption, expected to boost economic growth and job creation within the generics and biosimilars industry. However, such an exemption’s impact on the innovative research-based biopharmaceutical industry and on the international level of intellectual property (IP) protection remains in question. Methodology: Using evidence from the existing literature, a sample of 30 top-selling drugs, and France and Sweden as the primary source for SPC status within the EU we construct an econometric model and estimate potential annual losses to the global and the European innovative research-based biopharmaceutical industries. Results: This study finds that implementation of an EU-wide SPC manufacturing and export exemption would potentially result in annual losses ranging between USD2.675 billion and up to USD5.35 billion to the global innovative biopharmaceutical industry, with approximately USD1.34 billion to USD2.27 billion of these attributed to the European innovative biopharmaceutical industry. Translating these losses to current levels of biopharmaceutical sector employment and R&D investment the effect of the introduction of an EU-wide SPC manufacturing and export exemption could be between 4,500-7,700 direct job losses (with an additional 19,000-32,000 indirect job losses) and a decrease of between EUR215 million to EUR364 million in R&D investment. Conclusion: In light of these findings, we conclude that a manufacturing and export exemption is likely to have a detrimental effect on the European research-based biopharmaceutical industry and is unlikely to provide a significant and sustained positive economic impact on the European generics industry.

Competitive effects on the generics industry

Competitive effects on the generics industry

Generics in Europe

The generics industry in Europe has been at the forefront along with the United States in pushing the envelope and garnering support from cash-strapped governments to utilize the savings potential of generics in curtailing the overall healthcare spend. However, as we look to the next decade, the cost argument will remain important but will not be the sole mechanism to drive growth and create sustainability that is critical for the industry’s health. This article talks about four fundamental shifts that are shaping the future of the generics industry in Europe and what companies are doing to stay on top.

A victory for global public health in the Indian Supreme Court

On 1 April of this year, the Indian Supreme Court upheld the decision of the Indian Patent Office to refuse the patent grant for Novartis imatinib mesylate (Gleevec). The patent application failed to meet the requirements for patentability under Indian law. The global public health community followed the case closely. Its outcome could affect the Indian generics industry - an important supplier of low cost medicines to the developing world.

Generic Substitution in Malaysia: Recommendations from a Systematic Review

Generic substitution is the act of switching from a branded drug to its therapeutically equivalent generic version. This study aims to systematically review the literature with regards to generic substitution around the globe. Studies compared generic and brand-name drugs for clinical efficacy and cost effectiveness. The current findings show that the new policies are aimed at supporting the development of the generics industry in the respective countries. Further investigation is needed to explore the implementation of the current generic substitution policies and how to increase their accessibility to the general population. Generic substitution policies comparison between countries were conducted among 9 countries, that is, Australia, Canada, Czech Republic, Ireland, Japan, Switzerland, Indonesia, United State and United Kingdom. From 27 journals that were reviewed, only 14 were selected based on the fulfilled criteria appropriate to the journals that we had searched. All these policies were then studied to propose recommendations for generic substitution.

Psychiatric medicines in India: why public healthcare facilities and a thriving generics industry cannot assure access and affordability

This commentary highlights the poor availability of essential psychiatric medicines at public sector facilities in India and illustrates why even a flourishing generics industry does not assure access to affordable psychiatric medicines for most Indian patients. The paper outlines the Indian government's pricing regulations and then enumerates recommendations for reform.

BIOBOARD

EUROPE – Biomarkers for Autism Discovered. EUROPE – New Research Could Stop Tumor Cells From Spreading. EUROPE – Dutch Scientists Deliver Drugs with Nanorockets. EUROPE – "Living" Micro-Robot Could Detect Diseases in Future. EUROPE – Animal Import Bans Threaten UK Drug Research. EUROPE – £100M Welsh Biotech Fund Inspired by Sir Chris Evans. EUROPE – Scientists Discover New Plasmodium Mechanism. INDIA – Landmark Gleevec IP Case Makes Big Pharma Think Twice. INDIA – Indian Govt Defends Generics Industry. JAPAN – Japan May Open $96 Billion Drug Market Further. SINGAPORE – Temasek Foundation and Temasek Life Sciences Laboratory Collaborate in Myanmar. SINGAPORE – NCIS, NCCS and ESMO to Launch Cancer Education Initiative. TAIWAN – Taiwan Lags Behind South Korea in Biotech. TAIWAN – NCHU Inaugurates Taiwan-U.S. Research Center on Plant and Food Biotech. TAIWAN – Taiwan Offers New Model to Predict Hepatitis C Cancer Risk. TAIWAN – Nobel Laureate Dr. Ada E. Yonath to Lecture in Taipei. USA – BIO Opens Nominations for 2012 Biotech Humanitarian Award. USA – Pharmaceuticals Survey: Many Think Business Model Is Broken. USA – Probe Proteins Ultrafast with Infrared Spectroscopy. USA – This DNA Cannot be Replicated. USA – New Single-Cell, Single-Molecule Method to Identify DNA. USA – New Gene Therapy Approach Could Treat Sickle Cell. USA – Clamor Affects More than Birds and Other Animals. USA – The End of RNA World? USA – Curly Leaves Inspire New Technique for Shaping Thin Gel Sheets. USA – Mutant Plants May be Better for Biofuels. USA – Breakthrough in ID'ing Target Cancer Epigenetic Genes.

Tendering and decision-making: a case on pharmaceutical products

In order to contain expenditures for pharmaceuticals, the latest healthcare reforms have focused on decentralising German pharmaceutical market. Health insurance funds are now able to tender the products and subsequently conclude rebate contracts with one or more companies. Considering the enormous bargaining power of health insurance funds, pharmaceutical manufacturers, in particular companies in the generics industry, are facing an immense pressure to decrease their prices in order to win bids in these tenders. This empirical-based research study focus on a decision model that transforms basic information input into a decision tree is presented to offer practical support for decisioin-making in tendering procedures. The use of decision modelling tools (http://www.treeplan.com) such as objective hierarchies, influence diagrams, decision trees and sensitivity analysis can improve the quality of pricing decisions by forcing decision makers to base their decisions on clear thinking, appropriate assumptions and careful investigation of all alternatives.

Opportunities and Challenges in an Ever Generic World

The global generics industry is about to embark on a decade of seismic change, and the impact to both patients and health-care systems cannot be overstated. This paper provides an overview of the global pharmaceutical market in the context of today's economic crisis, and a corresponding outline of key trends shaping the global generics market. It then focuses-in on an examination of the trend toward centralized contracting and how it will benefit those generics manufacturers with a broad portfolio and low-cost manufacturing base.

Generics at the Crossroads: Will Europe Lead the Way Forward?

The generics industry is at a crossroads. Fundamental growth drivers remain unchanged, and should result in sustained long-term growth. However, growing cost and pricing pressures mean the industry of the future will look very different and the longer term impact of the financial crisis is still unclear. Future industry structure will also be determined by the extent to which genuine competition is allowed to emerge and to overcome the trend towards nationalist protectionist policies. The companies that succeed will be those that excel in four key areas: launches, differentiation, geographic presence and operational excellence. They will implement variations on three basic strategies: leveraging fixed costs/economies of scale, using new technologies and focusing on value products. Although many questions remain to be answered, including the future role of Europe, several global trends are clear, including ongoing industry consolidation and the growing importance of biosimilars. Otherwise, much will depend on developments in the European Union (EU), the world's largest single market. The EU offers an object lesson in the need for political leadership not only from the top but also at the national level, where varying approaches can have make-or-break importance for generic penetration rates and thus for the industry as a whole.

Generic versus Branded Pharmaceutical Strategic Considerations: An Irish Focus with Global Perspective

This article seeks to explore strategic considerations in the competition between generic and branded pharma drugs in Ireland. In a global environment, with trends in cost-saving substitution models and growing consumer awareness, Ireland has remained a high-price under-genericized market. Irish government initiatives toward control of drug expenses are influenced by factors such as quality, reliability of supply, and public perception and concerns. Other elements affecting market trends are changes in regulatory requirements, number of competitors, and health professionals’ preferences. These variables, among others, drive the necessity for strong strategy portfolios to be undertaken by the branded and generics industry alike. Indeed, such strategies may incorporate activities such as lobbying, negotiation, patent protection, brand defense, life cycle management, consolidation, and driving consumer awareness.

Developing the Japanese Generic Medicines Market: What Can We Learn from Europe?

This paper originates from a ‘Generics Industry Forum’ that debated the development of the Japanese generic medicines retail market. Based on these discussions, the paper conducts a descriptive analysis of Japanese generic medicines policy and proposes recommendations for further developing the market by learning lessons from the European experience. The Japanese generic medicines market has benefited from measures that assure supply and quality of generic medicines, provide information about generic medicines, speed up registration of generic medicines on the reimbursement list, allow and reward generic substitution by pharmacists, increase patient co-payment, and reward physicians who adopt generic prescribing and/or who allow generic substitution. However, several factors hamper the development of this market, including extensions to the data exclusivity period and patent term of originator medicines, the requirement to launch the same generic medicine strengths as the originator medicine, mandatory reductions of reimbursement tariffs and weak incentives for physicians, pharmacists and patients to demand generic medicines. In order to sustain the development of the Japanese generic medicines market, a number of avenues were proposed that focused on speeding up market access of generic medicines, implementing a reference-pricing system and strengthening incentives for physicians, pharmacists and patients to demand generic medicines.

Medicamentos genéricos no Brasil: impactos das políticas públicas sobre a indústria nacional

This paper echoes recent works of Abrasco, Gadelha and Guimarães emphasizing the need for a better integration between health policies and industrial development and innovation policies as the only way to keep the economic benefits generated by health expenditures in the country instead of letting them escape through imports and threaten the continuity of the social policy by growing trade deficits. Although presenting the generic drug policy as a successful case in integrating social policies aimed at a better access to quality drugs for the population with economic policies aimed at industrial development, this paper discusses the impacts and limitations of the referred policy in a dialog with Abreu's analysis of industrial competitiveness in the Brazilian generics industry.

Integrated API Distribution in Europe

Active pharmaceutical ingredient (API) distribution in highly developed generics markets must go different roads than in earlier days in order to be successful. This paper deals with the challenges and chances for today's API manufacturers in a changing environment. It has become crucial for API manufacturers to be part of successful generics development programmes in the generics industry. Service partners offer complete solutions for a launch of a new generic product on day one following patent expiration and so fill the pipelines of generics companies. It is as essential for API manufacturers to back the right horse as it is decisive in generics development to pick the right API partner. All or nothing at all - these are often the clear-cut choices.

Will India become the Global Centre for Pharmaceutical Research &amp; Development?

This paper is an edited version of a presentation given at the IGPA Conference in June 2005 in Malta. The global pharmaceutical industry is undergoing enormous change characterised by pressures on the big pharmaceutical sector, the advent of biotech and the global expansion of the generics industry. Big pharma continues to face difficulties with respect to productivity and the returns generated by its R&amp;D. However, growth of the generic industry is forecast to remain strong, as a result of burgeoning healthcare costs facing governments around the world and the global ageing population, leading to increased need for more affordable medicines. Against this background, India is emerging as one of the major centres for global pharma, whether it be in drug discovery and its related aspects or in the development of generic medicines. Until recently India was scarcely in the forefront, but today it is increasingly being considered as providing unique competitive advantages in R&amp;D and manufacturing. If India utilises these advantages optimally the result will be significant benefits to patients both in terms of innovative and newer medicines and more affordable alternatives around the world.

Sustentabilidade da política de acesso a medicamentos anti-retrovirais no Brasil

The expense of acquiring antiretroviral drugs in Brazil has given rise to debate about the sustainability of the policy of universal access to AIDS medications, despite the evident benefits. The objective of this study was to analyze the evolution of the Ministry of Health's spending on acquiring antiretroviral drugs from 1998 to 2005, the determining factors and the medium-term sustainability of this policy (2006-2008). The study on the evolution of spending on antiretrovirals included analysis of their prices, the year-by-year expenditure, the number of patients utilizing the medication, the mean expenditure per patient and the strategies for reducing the prices maintained during this period. To analyze the sustainability of the policy for access to antiretrovirals, the cost of acquiring the drugs over the period from 2006 to 2008 was estimated, along with the proportion of gross domestic product and federal health expenditure represented by this spending. The data were collected from the Ministry of Health, the Brazilian Institute for Geography and Statistics (IBGE) and the Ministry of Planning. The expenditure on antiretrovirals increased by 66% in 2005, breaking the declining trend observed over the period from 2000 to 2004. The main factors associated with this increase were the weakening of the national generics industry and the unsatisfactory results from the process of negotiating with pharmaceutical companies. The Brazilian policy for universal access is unsustainable at the present growth rates of the gross domestic product, unless the country compromises its investments in other fields.