Generic Drug Market Research Articles

Study of regulatory requirements for the conduct of bioequivalence studies in US, Europe, Canada, India, ASEAN and SADC countries: Impact on generic drug substitution

Design of dissolution media for in-vitro bioequivalence testing of Lamivudine Nagiat T Hwisa, Shanta Kumari Adiki, Prakash Katakam, Babu Rao Chandu

THE ROLL OF GENERIC DRUGS– QUALITY AND ECONOMIC ASPECT IN TREATMENT

Generic drugs have an important role in ensuring the efficacy, safety, and especially the economic aspect of drug use. A generic drug is a pharmaceutical product, usually intended to be interchangeable with an innovator product manufactured without a licence from the innovator company and marketed after the expiry date of the patent or other exclusive rights. At present, unlikely FDA’s regulations, Vietnam’s law does not require all generic drugs launching in the market to prove the bioequivalence, the same efficient and safe as innovator drugs. Because of the rapid growth of the domestic pharmaceutical market, the standard and quality of generic drugs compared with innovator drugs have to be consolidated and proved through trials of bioequivalence, then building the faith of professionals and patients in using generic drugs. Thus the expansion of number and improving quality of the bioequivalence assessment centers become an important task of Vietnam pharmaceutical industry in the context of integration with the global pharmaceutical industry. Key words: generic drugs, innovator drugs, patent, bioequivalence, treatment.

A STUDY ON THE MAGNITUDE OF HUMAN RESOURCE IN SUN AND RANBAXY MERGER

ABSTRACTSun Pharmaceutical is a trailblazer in Indian pharmaceutical sector, and one of the foremost competitors in the generic drug market sets its eye onRanbaxy. Sun pharmacy which was established in 1983 listed from 1994 has its upper hand in product development. Ranbaxy was incorporated in1973, and Daiichi Sankyo, a Japanese firm, got a controlling share from 2008. This amalgamation between Sun Pharmacy and Ranbaxy would getprofitable transaction for the former. The process of the coalition was a cloak and dagger affair until April 6, 2014. Before mergers and acquisitions,a company has to create an urgency call among the employees which will result in better understanding of the whole scenario. The aspects are abouthow financial motives and non-financial motives play a major role in mergers. This case deals with the human resource issues and complexities facedby the two players in the same business.Keywords: Merger, Acquisition, Change management, Human resource, Employee engagement, Corporate strategy.

A laboratory data-based evaluation of the efficacy and safety of generic pravastatin sodium for long-term use.

BackgroundIncreasing the use of generic drugs may reduce the growing healthcare spending. Nevertheless, in Japan, the generic drug market share remains low compared to that of European countries and the United States, mainly because of the general distrust of generic drugs. To address this problem, we retrospectively evaluated the efficacy and safety of the long-term use of generic pravastatin sodium in a study from January 2008 to December 2011.MethodsPatients receiving generic pravastatin sodium for ≥15 months were defined as long-term users and were included in the study, totaling 595 out of 1337 patients. Efficacy assessment was based on the total cholesterol (TC), triglyceride (TG), high-density lipoprotein (HDL), and low-density lipoprotein (LDL) plasma levels. Safety assessment was based on the aspartate aminotransferase (AST), alanine aminotransferase (ALT), creatine phosphokinase (CPK), gamma-glutamyl transferase (γ-GTP), alkaline phosphatase (ALP), lactate dehydrogenase (LDH), total-bilirubin (T-Bil), blood urea nitrogen (BUN), serum creatinine (Scr), and hemoglobin A1c (HbA1c) plasma levels. The patients’ reasons for discontinuing generic pravastatin sodium were obtained from the electronic medical records.Results & discussionNo significant difference in the laboratory data was observed between short-term and long-term users, except for significantly lower ALT levels in the long-term users than in the short-term users. No liver dysfunction was observed. Although 37 patients discontinued the study possibly owing to drug-related adverse events, we considered these events unrelated to generic pravastatin sodium.ConclusionsThis study shows that the long-term use of generic pravastatin sodium is effective and safe, and may help dispel the concerns about generic drugs.

10 years after implementation of TRIPS obligations in India.

The Patent (Amendment) Act of 2005 enforced after TRIPS raises many issues which hinder growth of Indian pharma companies. To tackle this, Indian pharma companies doubled their R&D expenditure and became significant players in global generic drug market. Indian pharmaceutical companies, which predominantly focused on import-oriented market, shifted to research-based approach by signing various agreements with MNCs that led to M&A and technology transfer. At the same time growth in R&D activities increased ANDA and DMF filing in the USA and Europe. Companies also kept their social responsibility by selling medicines at affordable price to patients. This paper highlights the changing business scenario of Indian pharmaceutical companies to counteract various issues evolved from new patent regime after TRIPS.

The Research on Price Strategy to Incent China's Drug Innovation

In the past few years, there has been a rapid development in China's generic drug market, while the new drug innovation performance is not outstanding. As an effective means to achieve multiple policies for the government, drug price not only maintains the new health reform target of drug accessibility and lower drug costs, but also plays a crucial role in drug innovation incentives. Through the analysis of current situation of Chinese medicine manufacturing drug innovation and existing problems, the authors discussed the role of drug price incentive compensation mechanism in innovation, and proposed the following price incentive strategy, using the pharmacoeconomics evaluation system, into the compensation directory, setting up the mechanism of drug price negotiations and by means of controlling medical costs.

Trade performance and revealed comparative advantage of Indian pharmaceutical industry in new IPR regime

Purpose – The purpose of this paper is to examine the trade performance, revealed comparative advantage and trade specialisation indices of Indian pharmaceutical in the post-modified Indian Patent Act. Design/methodology/approach – The main data sources for this paper are United Nations Conference on Trade and Development, PROWESS of Centre for Monitoring Indian Economy, Government of India reports and Reserve Bank of India databases. Revealed comparative advantage index (RCAI) and trade specialisation coefficient (TSC) have been calculated in the study. Findings – India is ranked third in regard of TCS, far behind Ireland and Israel. While Ireland has moved up the value chain faster after 1995, Israel has moved up swiftly after 2000 through global production network and supply chain. The Indian pharmaceutical industry, on the other hand, has largely capitalised on its low-cost production of generic drugs and a large domestic market. The RCAI also supports the results of TSC. India is positioned at 11th place, far behind Ireland, which stands tall at the top with distantly followed by Israel, Switzerland, Belgium, the UK, etc. Practical implications – The study shows the policy implications for future sustainable development of the industry as the new IPR regime has given opportunities as well as threats to both domestic pharmaceutical companies as well as the multinational corporations. The Indian pharmaceutical industry can be a good learning experience for other developing countries hopeful to enter the global market for generic drugs. Originality/value – There are no major studies providing detailed analyses of India’s comparative advantage vis-à-vis other leading exporters of pharmaceutical products in the world. This study endeavours to fill this gap. It also attempts to capture recent trends in exports and imports during the global recession period.

Bioequivalence and Therapeutic Equivalence of Psychotropic Drugs.

Introduction to the market of generic drugs has increased access to modern therapies and enabled significant reduction of their cost, leading to containment of public expenditures on drug reimbursement. The assessment of bioequivalence of reference and generic drugs is based on the assumption that two different drug products are equivalent when their rate and extent of absorption do not show significant differences when administered at the same dose under similar experimental conditions. However, despite regulatory declaration, switching from reference to generic drugs is often associated with concerns of healthcare providers about decreased treatment effectiveness or occurrence of adverse drug reactions. The aim of the present research was to retrospectively study therapeutic equivalence of selected reference and generic psychotropic drugs. In our preliminary data we show, that no significant differences in clinical outcome was observed in patients after the switch. It indicates, that bioequivalent drugs are also therapeutically equivalent and can be used interchangeably.

A Study of Pharmaceuticals in India and Kashmir Aspect

The Indian pharmaceutical industry positions among the top five countries by volume (production) and accounts for about 10% of worldwide production. The industry?s gross revenue has grown from a simple US$ 0.3 bn in 1980 to about US$ 21.73 billion in 2009-10. Stumpy cost of skilled manpower and innovation are some of the major factors taking sides of this growth. According to the Department of Pharmaceuticals, the Indian pharmaceutical industry employs about 340,000 people and an approximate 400,000 doctors and 300,000 chemists. The Indian pharmaceutical industry is disjointed with more than 10,000 manufacturers in the controlled and unplanned segments. The products manufactured by the Indian pharmaceutical industry can be generally classified into bulk drugs (active pharmaceutical ingredients - API) and formulations. Of the total number of pharmaceutical manufacturers, about 77% make formulations, while the remaining 23% make up bulk drugs. Bulk drug is an active constituent with medicinal properties, which acts as fundamental raw material for formulations. Formulations are precise dosage forms of a bulk drug or a mixture of bulk drugs. Drugs are available as syrups, injections, tablets and capsules. Based on the pharmaceutical consumer base, the Indian API manufacturing segment can be alienated into two sectors ? innovative or branded and generic or unbranded. In 2009, the worldwide generic drug market was projected to be US$ 84 billion, of which the US accounted for 42%. India‟s generic drug industry is approximate to be US$ 19 bn and it ranks third globally, contributing about 10% to global pharmaceutical production. Pharmaceutical manufacturing units are mainly concentrated in Maharashtra and Gujarat. These regions hold for about 45% of the total number of pharmaceutical manufacturing units in India. Based on the elevated value plant species, J&K has a huge potential for establishing bio-pharmaceutical industry.

Pharmaceutical R&D: an age of change?

Future Medicinal ChemistryVol. 6, No. 10 OpinionPharmaceutical R&D: an age of change?John J BaldwinJohn J BaldwinHua Medicine, Shanghai, China; E-mail Address: sixmilecross@verizon.netSearch for more papers by this authorPublished Online:31 Jul 2014https://doi.org/10.4155/fmc.14.69AboutSectionsView ArticleView Full TextPDF/EPUB ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareShare onFacebookTwitterLinkedInRedditEmail View articleKeywords: alliancesChinaeconomic strategiesgeneric competitionoutsourcingpricing structurerate of returnReferences1 Baldwin J. Is drug discovery dead? Future Med. Chem. 3(15), 1873–1876 (2011).Link, CAS, Google Scholar2 Mullen R. The future is now. Chem. Eng. News 91(49), 12–17 (2013).Crossref, Google Scholar3 Weinstein D. FDA's 2013 so far: 26 approvals. Medical Marketing and Media, 12 December (2013).Google Scholar4 Nearly 400 drugs in development for infectious diseases. www.pharmatech.com/pharmatech/Business/nearly-400-Drugs-in=Development-for-Infectious DiseasesGoogle Scholar5 PhRMA: more than 200 innovative medicines in development for heart disease and stroke. www.pharmalive.com/pharma-morethan200-innovative-medicines-in-development-for-heart-disease and stroke=?cid=nl_pharma_dailyGoogle Scholar6 PhRMA: drug companies have 444 medicines under development for neurological disorders. www.drugstoresnews.com/article/phrma-drug-companies-have-444-medicines-under-development-neurological-disorders?ad-latest-news.Google Scholar7 Robust biopharmaceutical pipeline offers new hope for patients. www.pharmalive.com/Robust-Pipeline-offers-New-Hope-for-PatientsGoogle Scholar8 Pal S. US pharmacist, shifts in the generic-drug market: trends and causes. US Pharm. 38(6), 6–10 (2013).Google Scholar9 Silverman E. Will the affordable care act give drugmakers a boost? Pharma and Healthcare, 26 December (2013).Google Scholar10 Trenton NJ. US prescriptions drug spending drops for first time in 58 years. CBS, 9 May (2013).Google Scholar11 Edney A, Larkin C. Drug approval reach 15 year high on smoother. FDA Reviews, 2 January (2013).Google Scholar12 Sonofi, regeneron drug cuts LDL in Phase III study. www.pharmalive.com/sanofi-regeneron-drug-cuts-ldl-in-phase-iiistudy?cid=nl.phrm02Google Scholar13 Merck, Glaxo start renal cancer trial. www.pharmalive.com/merck-glaxo-start-renal-cancertrial.Google Scholar14 Sell D. The Inquirer, GSK explores potential of bioelectronic devices. 22 December (2013).Google Scholar15 World Pharmaceutical Markets. The Challenge of the Chinese Pharmaceutical Market Quarter IV 2005 Espicom Business Intelligence. Lincoln House, Chichester, UK (2005).Google Scholar16 Genetic Engineering and Biotechnology News. Asia rises as U.S. share of global research funding falls. GEN News Highlights, 2 January (2014).Google Scholar17 Daverman R, Yeo T. China Investment 2013: Up, Up and Away: a five year analysis of investment activity in China's life science industry 2008–2012. China Bio LLC, Shanghai, China (2013).Google Scholar18 Herper M. The truly staggering cost of inventing new drugs. Pharma and Healthcare, 10 February (2012).Google Scholar19 Silverman E. Are drugmakers earning returns on their R&D investments. Pharma and Healthcare, 15 December (2013).Google Scholar20 Zamek-Gliszczynski M, Hoffmaster K, Tweedlie D, Giacomini K, Hillgien J. Highlights from the International Transporter Consortium Second Workshop. Clin. Pharmacol. Ther. 92(5), 553–556 (2012).Crossref, Medline, CAS, Google Scholar21 Benet L. The role of BCS (biopharmaceutics classification system) and BDDCS (biopharmaceutics drug disposition classification system) in drug development. J. Pharm. Sci. 102(1) 34–42 (2012).Crossref, Medline, Google Scholar22 Staton T. China hits big pharma meds with 15%-plus price cuts. Fierce Pharma, 8 January (2013).Google Scholar23 China significantly ratchets back drugs on ‘essential drugs’ list. www.fiercepharma.com/china-significantly-ratchets-backdrugs/2012-08-20Google ScholarFiguresReferencesRelatedDetails Vol. 6, No. 10 Follow us on social media for the latest updates Metrics Downloaded 114 times History Published online 31 July 2014 Published in print June 2014 Information© Future Science LtdKeywordsalliancesChinaeconomic strategiesgeneric competitionoutsourcingpricing structurerate of returnFinancial & competing interests disclosureJJ Baldwin has an association with Hua Medicine and CarysBio along with stock holdings with several US pharma. The author has no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.No writing assistance was utilized in the production of this manuscript.PDF download

On working for Henry Waxman.

On working for Henry Waxman.

Factors influencing anti-asthmatic generic drug consumption in Morocco: 1999-2010.

BackgroundThe increasing availability of generic drugs (GD) resulted in a remarkable reduction in treatment costs that allowed a better access to health care.The aim of this study is to evaluate the share of anti-asthmatic generic drugs during the period 1999-2010 in Morocco and to look at the factors influencing generic development.MethodsIn this study, we used Moroccan sales data from IMS Health (Intercontinental Marketing Services). The consumption of the drugs was expressed in DDD/1000 inhabitants/day according to the WHO ATC/DDD methodology.ResultsBetween 1999 and 2010, anti-asthmatic consumption increased from 3.91 to 14.43 DDD/1000 inhabitants/day. The market of anti-asthmatic generic drugs progressed from 1.83 (47%) to 2.18 (23%) DDD/1000 inhabitants/day from 1999 to 2010. In 2010, inhaled glucocorticosteroids ranked first (0.83 DDD/1000 inhabitants/day), followed by inhaled short acting beta agonists (0.73 DDD/1000 inhabitants/day). The number of brands went from 27 in 1999 to 34 in 2010, with a generic share increasing from 55.55% to 70.59%. The number of anti-asthmatic pharmaceutical preparations increased from 57 to 64 during the same period, of which 31 and 42 were generic preparations. In 2010, the total cost of anti-asthmatic dugs was about 22 million euro, the generics representing 14 million euro.ConclusionDespite the introduction of a compulsory insurance scheme called “AMO”, that allows a refund for 69.5% of anti-asthmatic specialties marketed in Morocco, anti-asthmatic generic drug consumption remains limited. The Moroccan market is still largely dominated by the originator drugs with still valid patents.

Competitive dynamics in pharmaceutical markets: A case study in the chronic cardiac disease market

A modelling project involved system dynamics simulation of chronic cardiac disease in Bulgaria, examining the dynamic behaviour of a cardiac drug molecule in the market. The system dynamics model was calibrated using market data sourced from the Bulgarian National Health Care Fund, the Bulgarian Generic Pharmaceutical Association and a market research firm. The main results of the study showed that the timing of access to market was a critical driver in reducing prices and providing wider, as well as more affordable, access for patients to medicinal therapy. Our findings indicate that healthcare authorities may obtain savings while, at the same time, they may provide conditions for more patients to be treated depending on the timing of access to market of new generic drugs.

Perverse reverse price competition: Average wholesale prices and Medicaid pharmaceutical spending

Generic drugs comprise an increasing share of total prescriptions dispensed in the U.S., rising from nearly 50% in 1999 to 75% in 2009. The generic drug market has typically been viewed at the wholesale level as a competitive market with price approaching marginal costs. However, the large presence of third party payers as final purchasers may distort prices at the retail level relative to what a standard model of price competition would predict. In this paper, we investigate how generic drug producers compete in the presence of the procurement rules of the Medicaid program. Medicaid reimbursement to pharmacies, like that of other payers, is based on a benchmark price called the average wholesale price (AWP). The AWP is reported by generic producers themselves, and until recently has been subject to essentially no independent verification. As a result, generic producers have had an incentive to compete for pharmacy market share by reporting AWPs that exceed actual average wholesale prices, as this “spread” leads to larger pharmacy profits. In 2000, after a federal government audit of actual wholesale prices of generic products, states were advised to reduce Medicaid reimbursement by as much as 95% for about 400 generic and off-patent drug products. We use variation induced by the timing of this policy along with its differential impact on drug products' Medicaid reimbursement to estimate the impact of this exogenous price change on the market share of targeted products. Our findings indicate that pharmacies did respond to the perverse incentives of the Medicaid program by dispensing products with the highest AWPs. Overall, the Medicaid market share fell by about 45% for targeted drug products as a result of the policy.

Les médicaments génériques et l’évolution de la consommation des antihypertenseurs au Maroc

To evaluate the evolution of consumption of antihypertensive drugs generic among 1991-2010, to assess the impacts after the institution of Mandatory Health Insurance and the marketing of generic drugs. We used sales data from the Moroccan subsidiary of IMS Health Intercontinental Marketing Service. Consumption of generic antihypertensive drugs increased from 0.08 to 10.65 DDD/1 000 inhabitants/day between 1991 and 2010. In 2010, generic of the calcium channel blockers (CCBs) represented 4.08 DDD/1 000 inhabitants/day (82.09%), followed by angiotensin converting enzyme inhibitors (ACEI) by 2.40 DDD/1 000 inhabitants/day (48.29%). The generics market of CCBs is the most dominant and represented in 2010, 79.21% in volume and 62.58% in value. In developing countries like Morocco, the generic drug is a key element for access to treatment especially for the poor population.

Drug Development in the 21st Century: The Synergy of Public, Private, and International Collaboration.

The traditional economic model for drug development by leading pharmaceutical companies in the developed world has yielded diminishing returns in recent years, with large pharmaceutical companies relying less on research and development and more on cost cutting and obtaining promising drug candidates through mergers and acquisitions. Concurrently, drug companies in emerging markets have flourished under a different economic model characterized by public-private partnerships, government subsidy, and profitable marketing of generic drugs. These companies are now focusing on research and development of innovative drug candidates, including drugs that treat neglected diseases such as tuberculosis and hepatitis. However, drug companies in developing countries may lack the expertise of leading drug companies to navigate the complicated regulatory system. This article highlights an opportunity for companies with drug development expertise to partner with companies in the developing world with innovative pipeline drugs.

Despite Recent Reforms, Provinces Continue to Pay Too Much for Generic Drugs, Says Study

Provincial governments seeking to cut spending on generic drugs — by reducing prices to a lower percentage of the brand-name equivalent — are still overpaying for most of these drugs, according to a study from the Centre for Health Services and Policy Research at the University of British Columbia. The research was conducted by Dr. Michael Law, assistant professor at the Centre and an expert adviser with EvidenceNetwork.ca. Dr. Law focused his analysis on generic drug expenditures in Ontario, as that province has gone the furthest by reducing generic prices to 25% of the brandname cost, and so has the lowest prices in Canada. “I was interested in evaluating the real impact of the dramatic percentage reduction in Ontario, from 65% to 25%,” says Dr. Law. “Paying one-quarter of the brand price sounds like a great deal, but the numbers say other wise, when you examine whether these new prices are internationally competitive.” The study compared the 2011 prices of generic drugs on the Ontario Drug Benefit Formulary to price listings for 2 other public drug programs — the US Department of Veterans Affairs and the New Zealand government. Out of the 100 most frequently dispensed generic products in Ontario, 82 were listed on one or both of the other programs. “Among those 82 drugs, 90% of the time, they were more expensive in Canada than in the 2 comparator countries and on average, they were twice as expensive,” says Dr. Law. The largest price discrepancy was for simvastatin (10 mg), which was more than 30 times more expensive in Ontario. If the Ontario government had paid the best comparator prices for the 82 generic products, it would have saved $129 million in 2011, according to Dr. Law's study. Extrapolating to the total Ontario market, the savings would be $245 million. The traditional and arbitrary formula of setting generic prices as a percentage of brand-name prices is not optimizing savings, according to Dr. Law. The other countries use different mechanisms to achieve better pricing, he says. “If you look at New Zealand, for example, it uses contractual agreements with firms that guarantee them a certain amount of volume for a particular price and use competition to get the best price possible.” Dr. Law is encouraged by the recent commitment of Canada's premiers to have the provinces collaborate on bulk purchasing of generics. “In the generic drug market, there is genuine competition. If we can capture some of that competition then I am hopeful that the provinces will be successful in this initiative.” Canada's potential purchasing power could provide an advantage, he adds. “If you banded all the provinces together, our public programs are bigger than both of those other insurance schemes by a wide margin.” Achieving savings in the per-unit price of generic drugs could yield multiple benefits, says Dr. Law. “Governments could not only save money, they could improve coverage for people. With estimates like the one our Centre put out earlier this year — that 1 in 10 Canadians can't afford their prescription drugs — I think there's a real opportunity here to get better prices and improve coverage at the same time.”

PHP16 Generic Drug Market Access in Japan

PHP16 Generic Drug Market Access in Japan

Project risk evaluation with design of experiment: A case of developing a generic drug analytic method development project

Generic drugs are equivalent to branded drugs but at a cheaper price. The generic drug market is highly competitive and the drug companies tend to improve their market position by being first in the market when the patent on an original drug elapses. It is because if a company gets the first approval from Food and Drug Administration (FDA), 6 months of marketing exclusivity will be granted and the company can take the granted period to grab the lion's share of the drug's market. Thus, the time-to-market of new products is crucial to their comparative advantages. FDA requires drug companies to submit Abbreviated New Drug Application (ANDA) which contains all the information that would have been in a pioneer drug application except for safety and effectiveness. Thus a robust and efficient analytical testing method for ANDA project is essential. This study proposes a method development scheme which integrates project risk evaluation with a design of experiment to efficiently carry out the critical project under ANDA programme in order to get the revenue early on. A case is implemented to demonstrate the efficiency of this integration.

The new patent regime and disease priorities in India

The World Trade Organization (WTO) and Trade-Related Aspects of Intellectual Property Rights (TRIPS), which made product patents compulsory for countries to follow, meant that the entire market for generic drugs was out of bounds for manufacturing till the time the products went off-patent. The TRIPS has generated widespread discussions and debates around the costs and benefits of new patent regimes on countries such as India. This article analyses whether the post-WTO system was consistent with, and conducive to, improved public health in India. It is a first-of-its-kind effort in which the data on pharmaceutical patents applications were collected, collated, cleaned and classified according to IPC codes, to enable preliminary understanding of the nature and type of the applications. The patent applications that are filed in India are not found to be consistent with the disease burden of the country.