Generics
EMA launches European shortages monitoring platform to tackle persistent medicine shortages
The European Medicines Agency (EMA) launched the European Shortages Monitoring Platform (ESMP) to address persistent medicine shortages across the European Union (EU). This centralized system improves reporting, monitoring, and management, ensuring medicine availability during crises and public health emergencies, and will be mandatory from 2025.
Japan’s drug shortage crisis: challenges and policy solutions
Drug shortages are worsening worldwide [1, 2], and Japan is facing significant challenges due to a combination of factors. One major issue arises from the shift from brand-name to generic drugs, coupled with scandals involving poor manufacturing and development practices. These shortages affect access to essential treatments, prompting calls for action from pharmaceutical companies and the government.
Saudi FDA drug approvals and GMP inspections: trend analysis
A GaBIJ Review Article entitled ‘Trends in Saudi FDA drug approvals and GMP inspections: an observational study’, was published by a group of authors, Alhomaidan et al., from Saudi Food and Drug Authority (SFDA) in October 2023 [1].
FDA approves generic teriparatide and levetiracetam
Two generic versions of osteoporosis treatment, Forteo/Forsteo (teriparatide injection), developed by Teva and Ambio, were approved by the US Food and Drug administration (FDA) in November and December 2023. Although teriparatide is a biological, the new products have been produced synthetically and are therefore generic versions and not biosimilars, of the originator. In addition, Strides Pharma has received approval for its generic seizure medication, levetiracetam.
Generic medications in the Lebanese community: understanding and public perception
A study conducted by Hatem G and Itani R et al. found that factors such as regulatory standards and quality assurance can influence people’s perception of generic drugs. This research involved 385 patients recruited from six public healthcare centres in Lebanon. Like in many countries, the regulatory authority in Lebanon ensures that generic drugs meet the same standards as brand-name drugs.
Generic drug growth in Brazil and Venezuela
Over the past few years, both Brazil and Venezuela have witnessed an increase in the production, growth, and acceptance of generic medicines in their respective healthcare systems.
Community pharmacists’ understanding of generic and biosimilar drugs: Lebanon case study
A study conducted by Awada S et al. stated that several factors can contribute to a lack of knowledge among community pharmacists regarding the differences between biosimilar and generic drugs. According to the authors, understanding the scientific and regulatory aspects of biosimilars can be challenging, primarily due to the limited clinical experience in dispensing biosimilars, which leads to misconceptions about their characteristics [1].
Reshaping landscape of Japanese generics market – uncertain future of universal health insurance
According to a study conducted by Kosaka M et al., Japan established a national health insurance scheme in 1961. This scheme ensured that the entire Japanese population has equal access to medical care by paying only 10%–30% of the medical cost from their own pocket [1]. Despite the advancement of medical technology and a fast-ageing society, Japan’s healthcare costs have continued to rise. However, the Japanese government has failed to offer a fundamental solution and has instead implemented interim measures, with a notable example being the encouragement of generic drug utilization [2]. Similar issues and challenges have been observed in wealthy Organisation for Economic Co-operation and Development (OECD) Asian health markets [3].
Impact of e-bidding procurement on generic omeprazole injection prices in Thailand
To address Thailand's increasing drug costs, the government implemented e-bidding for drug procurement. In a study by Pentrakan et al., e-bidding reduced omeprazole injection prices by 17.35% per vial and enhanced the procurement process. Nonetheless, maintaining a balance between innovation and involving local suppliers is vital for success [1].
Market penetration of generic drugs in Mexico and Brazil
Generic drugs represent a great advance both in Brazil and Mexico, as they allow the population to access affordable, safe and effective treatments.
Trajectories of prices in generic drug markets
In a study by Trujillo AJ et al., the authors adopt a group-based trajectory modelling approach to analyse the price trends of generic drugs. The analysis is conducted using price data collected quarterly over the past decade from the IBM MarketScan claims database. The study focus is to understand the trajectory patterns of these drugs and identify factors that may have influenced their pricing over time [1].
Evaluation of pharmaceutical equivalency of manufactured generic drugs in UAE
Generic medicines are pharmaceutical products manufactured to be equivalent to the brand or innovator drug products. They represent the majority of worldwide prescribed medicines; therefore, their quality is critical to ensure equivalent therapeutic outcomes
New insights into the amount of R & D for new uses of generic drugs
Generic drugs are considered indispensable to healthcare systems because they are substantially cheaper than original versions of the drugs. These drugs have become common place, within healthcare delivery, because of the anticipated financial benefits [1].
FDA releases one-year progress report for the Generic Drug Cluster
The US Food and Drug Administration’s (FDA) one-year progress report for the Generic Drug Cluster – a multi-country forum on generic drugs – explains the purpose of the Cluster and key achievements made so far.
US generics launch and approval for Dr Reddy’s and Lupin
On 7 September 2022, Dr Reddy’s Laboratories (Dr Reddy’s) announced the US launch of their generic lenalidomide capsules. And in July 2022, Lupin announced that its generic azilsartan medoxomil tablets had been approved by the US Food and Drug Administration (FDA).
Pricing and reimbursement of medicines in Canada
Canada is a wealthy country with gross domestic product (GDP) per capita of US$43,258 in 2020. It ranks 16th in the United Nations’ Human Development Index and is one of the most multicultural countries in the world. Canada’s population of more than 38 million includes a significant indigenous population. Its huge land mass means it is very sparsely populated outside urban areas. Authors from Canada and Brazil discuss the pharmaceutical pricing and reimbursement policies in Canada [1].
Medicines pricing conditions in Italy and Brazil: comparison of regulations
In the context of the National Health Services (NHS), the gearing that moves the health services comprises a legal framework, permeated by technical and economic parameters.
Pharmaceutical manufacturing companies in Brazil
Brazil is a country active in life sciences research, publications, manufacturing and exports. Biosimilars have the highest growth potential for the pharmaceutical sector in Latin America [1].
Pharmaceutical companies in Argentina
Argentina has an important pharmaceutical sector, being the third largest market in Latin America after Brazil and Mexico. Pharmaceutical companies from Denmark, France, Germany, Switzerland, the UK and the US are stablished in Argentina. Argentine market has extensive experience in the incorporation of foreign investments for the sector as well as offers multiple business opportunities.
Relevance of NTI to the treatment of epilepsy
In a mini review, author a Roy G Beran discusses what is the relevance of a narrow therapeutic index (NTI) to the treatment of epilepsy [1].
Pharmaceutical companies in Latin America and the Caribbean
According to a research carried out by Vargas V, et al. 2022, pharmaceutical innovations, together with higher living standards and more effective public health interventions, have been significantly important to extend life expectancy and improve population quality of life in Latin America and the Caribbean [1].
What is the meaning of a narrow therapeutic index?
What is the meaning of a narrow therapeutic index (NTI) is a topic explained by author Roy G Beran, in a mini review [1].
Canada calls for support to national pharmacare and generics industry
Canada has made a federal budget commitment to supporting a national pharmacare programme. This can be bolstered through strengthening Canada’s domestic generics pharmaceutical industry.
What is meant by a generic medication and generic equivalence?
Author Professor Roy G Beran, in a mini review, explains what generics are and what is meant by generic equivalence [1].
Consequences of generics being favoured by healthcare providers
Generics are favoured by healthcare providers due to a variety pf reasons, according to author Roy G Beran [1].
UK NHS faces drug shortages
The United Kingdom’s (UK) National Health Service (NHS) faces shortages of blood pressure pills, painkillers and antidepressants due to drug manufacturer supply problems.
The cost of developing drugs and use of generics
In a mini review, author Professor Roy G Beran explains how generics can be produced at a much lower cost than originator drugs [1].
Re-evaluation of the use of generics, especially when treating conditions such as epilepsy
Regulatory bioequivalence rules for generics are well established and recognized. However, proving bioequivalence may not always be so easy, especially with drugs with a narrow therapeutic index (NTI) [1].
Repurposing generic drugs can save time and money
Repurposing generic drugs for new indications could save time and money compared to developing new treatments and represent a cost-effective way of addressing unmet medical needs, argues a new article by a University of Michigan professor [1].
Availability of medicines and the sustainable development of the national health system in Russia
The modernization of the drug supply system for citizens as a multifaceted process that ensures the sustainable development of the national health system is the focus of attention of the economy, the state and society. In order to study this, authors from Russia carried out a study to analyse the availability of medicines for the population for the treatment of cardiovascular diseases in 2011 and 2019 [1].
Five Chinese companies join UN’s MPP for Covid-19 medicines
Five pharmaceutical companies in China have signed up to the United Nation’s (UN) Medicine Patent Pool (MPP) which will allow them to produce generic versions of Pfizer's oral COVID-19 treatment, Paxlovid (nirmatrelvir/ritonavir), for distribution in 95 low- and middle-income countries, approximately 53 per cent of the world's population.
High drug bills? Turn to your pharmacist for help
Many Americans require prescription drugs on a daily basis. With year-on-year price increases of branded products, turning to pharmacists for advice could reduce the financial strain on households [1, 2].
South Korean companies to make generic Bridion and COVID-19 drugs
In South Korea, 19 pharmaceutical companies have obtained marketing approval for generic drugs of MSD’s Bridion (sugammadex). In addition, Korean pharma companies Celltrion, Dongbang and Hanmi Pharmaceutical, will be supplying generic COVID-19 drugs to middle- and low-income countries.
Revlimid (lenalidomide) generics launch across Europe
In late February 2022, a number of generics of Revlimid (lenalidomide) were launched in Europe. These will now rival Bristol Meyers Squibb’s blockbuster oncology medicine.
FDA Office of Generic Drugs publishes 2021 annual report
The US Food and Drug Administration’s (FDA) Office of Generic Drugs annual report reveals the importance of innovation and scientific collaboration in advancing the generic drug programme in 2021.
Cancer and diabetes generic treatments receive positive opinion from EMA’s CHMP
The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) announced on 28 January 2022 that three generic medicines had received a positive opinion from the committee.
COVID-19 vaccine produced in Latin America
The World Health Organization (WHO) approved a COVID-19 vaccine produced in Latin America at the end of 2021. It is a version of the immunizing agent from the Anglo-Swedish laboratory AstraZeneca, manufactured jointly by Argentina and Mexico.
Generic etoricoxib is equivalent to the reference drug
A study comparing generic etoricoxib (ETO) to the originator drug Arcoxia [1] finds that the generic version of the drug is bioequivalent to the reference compound, according to the Association of Southeast Asian Nation (ASEAN) bioequivalence guidelines.
FDA approves first Restasis generic
On 2 February 2022, the US Food and Drug Administration (FDA) approved the first generic of Restasis (cyclosporine ophthalmic emulsion).
FDA approves schizophrenia and anti-allergy drugs
The US Food and Drug Administration (FDA) has granted tentative approvals to Zydus Cadila and Morepen Laboratories for treatments for schizophrenia and allergy symptoms, respectively.
Drug shortages hit Japan and Europe
Shutdowns of pharmaceutical companies have led to shortages of generic drugs in Japan, while in the EU, existing shortages have been exacerbated by the COVID-19 crisis.
Generics applications under review by EMA – January 2022
Generic medicines in Europe can be approved either centrally via the European Medicines Agency (EMA) or nationally via the local regulatory body [1]. Approval by EMA takes place by using a centralized procedure. This leads to approval of the product in all 28 European Union (EU) Member States and in Iceland, Liechtenstein and Norway. At a country level, if approval in a single EU Member State only is required, this can take place using the national procedure. However, as soon as a company seeks approval in two or more Member States, a decentralized procedure or mutual recognition procedure must be used [2].
Medicines repurposing project launched in Europe
In late October 2021, the European Medicines Agency (EMA) and the Heads of Medicines Agencies (HMA) announced the launch of a pilot project to support the repurposing of medicines.
Pfizer to produce generic COVID-19 pill in eight countries of Latin America
US-based pharmaceutical company Pfizer announced a licensing agreement to allow other manufacturers to produce generic versions of its COVID-19 pill Paxlovid (PF-07321332*) in order to generate more affordable access to developing countries.
MPP agreements allow generics production of Merck and Pfizer’s COVID-19 treatments
In October and November 2021, Merck and Pfizer signed licensing agreements with the United Nation’s backed Medicines Patent Pool (MPP) to help increase access to their investigational COVID-19 oral antiviral treatment options. Respectively, these are molnupiravir and Paxlovid. Creating these royalty free licences will allow for generic versions of the drugs to be produced and distributed in approximately 100 low- and middle-income countries worldwide.
First eslicarbazepine epilepsy generic to be approved in China
In China, the Yangtze River Pharmaceutical Group submitted the first marketing application of a class 3 generic drug, eslicarbazepine acetate, for use to treat patients with epilepsy, on 15 October 2021.
FDA closes Zhejiang Huahai Pharmaceutical warning letter
The US Food and Drug Administration (FDA) has stated that it has closed the warning letter issued to Chinese manufacturer Zhejiang Huahai Pharmaceutical in 2018.
Pfizer and Merck COVID-19 antiviral progress
Pfizer has announced that its COVID-19 oral antiviral candidate, Paxlovid, can significantly reduce hospitalization and death of COVID patients. At the same time, Merck is under pressure to get its COVID-19 antiviral, molnupiravir, to reach those in developing countries.
FDA reaches 100 generics approvals
As of September 2021, the US Food and Drug Administration (FDA) has reached an important milestone of approving more than 100 generic drug applications with a competitive generic therapy (CGT) designation.
Call for drug pricing transparency
By 2023, pharmaceutical expenditure is expected to reach US$1.5 trillion [1]. This causes significant strain on healthcare systems worldwide and work is underway to bring pharmaceuticals’ spending down.
Sun Pharma and Dr Reddy’s generics progress in EU and US
October 2021 saw the steps forward in the approval of a Sun Pharmaceutical’s sitagliptin fumarate generic in Europe, and Dr Reddy’s lenalidomide generic in the US.
High price of cancer medicines make treatment unaffordable globally
Cancer is the leading cause of death worldwide. Currently, there are increasing concerns about the price of cancer medicines and how this can limit patient access to lifesaving treatments. Now, a new study published in Applied Health Economics and Health Policy [1] calls for strengthened pricing policies that can ensure affordable cancer treatment for all.
Oncology generics launched by MSN Labs and Natco Pharma
In late September 2021, MSN Labs launched Cabolong, a branded generic of Cabozantinib for treatment of renal cell carcinoma in India. This was followed by the early October announcement that in the US, Natco Pharma launched 10 mg strength everolimus tablets, an oncology generic of Novartis’ Afinitor.
US brand-name drug market exclusivity periods remain relatively unchanged over the past decade
The passage in 1984 of the Hatch-Waxman Act set into motion sweeping changes to the US brand-name and generic drug competitive environment. It greatly increased generic drug competition for small-molecule drugs, by establishing a new abbreviated new drug application (ANDA) generic drug approval process that substantially reduced the time and cost associated with a generic drug marketing application submitted to the US Food and Drug Administration (FDA). In addition, it created incentives for challenges to brand-name drug patents, while also creating incentives for continued medical innovation and new drug development by drug innovators.
Considerations for the evaluation of generic IUDs containing levonorgestrel
Fertility regulation benefits the population, protecting the right to life and health, supporting the right of individuals to enjoy their sexuality and the right of children to be born wanted. In addition, it safeguards people’s freedom of conscience to decide whether or not to use a contraceptive method, based on their personal values, safeguards the principle of non-maleficence and the principle of equity and justice. This is fulfilled when services are universally accessible without discrimination and authorities monitor that this condition is respected. Currently, different types of contraceptive methods are available, which are classified into hormonal, barrier, long-acting reversible contraception, emergency contraception and sterilization. All of them must meet the basic conditions of efficacy, safety, acceptability, availability and reversibility.
New five-year medicines agreements in Australia
The Australian Government has entered into five-year strategic agreements with Medicines Australia and the Generics and Biosimilar Medicines Association (GBMA), to improve access to affordable, innovative, and life-saving therapies, vaccines and medicines.
Generic pharmaceutical policies in the MENA region
Healthcare systems in the Middle East & North Africa (MENA) region face challenges in service funding and delivery with policy emphasis in the region currently focused on controlling pharmaceutical expenditure. A key component of pharmaceutical cost-containment is a strong policy for generics aiming to improve uptake and access.
Sandoz launches ferumoxytol and pemetrexed generics
Sandoz has launched ferumoxytol iron deficiency anaemia (IDA) treatment in the US and pemetrexed oncology treatment in Europe.
Generics applications under review by EMA – July 2021
Generic medicines in Europe can be approved either centrally via the European Medicines Agency (EMA) or nationally via the local regulatory body [1]. Approval by EMA takes place by using a centralized procedure. This leads to approval of the product in all 28 European Union (EU) Member States and in Iceland, Liechtenstein and Norway. At a country level, if approval in a single EU Member State only is required, this can take place using the national procedure. However, as soon as a company seeks approval in two or more Member States, a decentralized procedure or mutual recognition procedure must be used [2].
The generics market in Brazil
The Brazilian pharmaceutical market has undergone many changes since the introduction of generic drug laws.
US generic approvals for Acrux and Cipla
In late June 2021, Australian pharmaceutical company Acrux received United State Food and Drug Administration (FDA) approval to market its generic version of Vallant’s Jubila (efinaconazole). In addition, Indian generics maker Cipla received final FDA approval for a generic version of Sunovion Pharmaceuticals Inc’s Brovana, an arformoterol tartrate inhalation solution.
Laws on packaging, substitution and prescription of generics in Brazil
According to the National Health Surveillance Agency (Agencia Nacional de Vigilancia Sanitaria, ANVISA), the approval of medicines aims to improve the Brazilian population's access to better, safe and quality medicines at lower prices.
Legal requirements on equivalence studies for generics in Brazil
The creation of the legal system for generic medicines began with the introduction of Law Number 9787 in February 1999 (Brazil 1999). According to the National Health Surveillance Agency (Agencia Nacional de Vigilancia Sanitaria, ANVISA), the approval of medicines aims to improve the Brazilian population's access to better, safe and quality medicines at lower prices.
Backlog of drug patents in Brazil
In an article on ‘How much does the backlog on drug patents cost for health in Brazil?’, Jannuzzi et al. in 2017 [1] showed backlogs in the analysis of patent applications in Brazil. These delays, known as ‘backlogs‘, extend the term of patents granted on medicines and delay the entry of generics into the market.
Natco cancer generic approval and advances for Lannett asthma and diabetes products
In early June 2021, US Food and Drug Administration (FDA) approved Natco Pharma’s abbreviated new drug application (ANDA) for carfilzomib vials, a generic version of anticancer drug Kyprolis. It also accepted Lannett’s ANDA for their generic version of asthma treatment Adavir Diskus, fluticasone propionate and salmeterol inhalation powder.
Use of generics increases during the COVID-19 pandemic in Mexico
During the last month of July 2020, the pharmacist sector affiliated with the National Association of Medicines Retailers (Asociación Nacional de Distribuidores de Medicina A.C, ANADIM) reported an average sales growth of 23% fostered by the demand of generic medicines.
FDA approval for schizophrenia and HIV generics from Zydus Cadila and Lupin
On 27 May 2021, Zydus Cadila received US Food and Drug Administration (FDA) approval to market fluphenazine hydrochloride tablets which is used to treat schizophrenia and other types of mental condition. On 7 June 2021, Lupin Ltd received approval for emtricitabine and tenofovir disoproxil fumarate tablets which are used in combination with other antiretroviral agents for the treatment of HIV.
Non-profit generics manufacturers in the US reduce foreign dependence
Non-profit generics drug manufacturers have the potential to make important contributions to reduce foreign dependence on generic drugs in the US, argues an article published in The Journal of Law Medicine and Ethics [1].
COVID-19 IP waivers could lead to global pharma patent changes
At the Nikkei Future of Asia conference in Tokyo on 20 May 2021, Malaysian Prime Minister Tan Sri Muhyiddin Yassin announced that he believes Asia should lead in opening-up patent protections to produce generic versions of life-saving medicines.
COVID-19 favipiravir treatment production opens up in Thailand
In Thailand, the patent application for favipiravir, a drug widely used to treat COVID-19, has been rejected. This now allows local generics production of the antiviral medication and human trials of a Thai-made version of the drug are underway.
More out-of-pocket costs for US patients with rising prescription drug prices
Increasing prices of brand-name drugs in the US, leaves patients with increasing costs at the pharmacy, says a study published in JAMA Network Open [1].
Zydus Cadila and Sandoz generics approvals in North America
In April 2021, Zydus Cadila received final approval from the US Food and Drug Administration to market its ibrutinib and macitentan generics. In addition, in May 2021, Sandoz Canada announced the launch of their pirfenidone, a generic version of F. Hoffmann-La Roche’s Esbriet®.
Difficult-to-make drugs meet US quality standards
Difficult-to-make prescription pharmaceuticals marketed in the US consistently meet quality standards even when manufactured outside the country, finds a study published in JAMA Network Open [1].
New in vitro–in vivo simulations predict generic bioequivalence
If we can predict the outcome of bioequivalence studies in the generic drug development process, we can save time and money. Now, a new in vitro–in vivo simulation (IVIVS) approach to predict the in vivo outcome of these studies, published in Materials [1], has been developed by researchers National and Kapodistrian University of Athens.
EMA recommends approval of abiraterone and ioflupane (123I) generics
The European Medicines Agency’s (EMA) Committee for Medical Products for Human Use (CHMP) recommended granting marketing authorizations for two generic medicinal products at its April 2021 meeting.
Generics in India
India is the world’s largest generic drugs producer, yet the generics market within the country is relatively small. In a recent article [1], Sajid Sheikh and Gunjan Deshpande of the Maharashtra National Law University, Mumbai, explore the current status of generics in India.
Tentative US approval for Symbicort generic
On 8 March 2021, Viatris Inc and Kindeva Drug Delivery LP announced that the US Food and Drug Administration (FDA) has granted the tentative approval of their generic version of Symbicort® (budesonide/formoterol).
US$1.2 FDA contract for generic drug computational tool
The US Food and Drug Administration (FDA) Office of Generic Drugs (ODG) has awarded a US$1.2 million contract to support the development of a computational tool that will aid generic drug research.
Dispensing branded drugs costs Medicare over a billion dollars
Branded drugs dispensed instead of generics at the request of physicians and patients have incurred annual costs of over US$1 billion to the Medicare programme. and US$270 million to patients, reveals a study published in JAMA Network Open [1].
Technological approaches to drug repurposing for cancer treatment
Cancer is one of the leading causes of death in the world today, causing nearly 10 million deaths in 2018 alone. Despite extensive research into new treatments, when these eventually reach the market, they are often very expensive. The strategy of drug repurposing is being applied to identify already approved drug products as potential cancer therapies. This can bring new cancer treatments to patients faster and at a lower price. A review, published in Signal Transduction and Targeted Therapy [1], summarizes approaches used for drug repurposing and discusses the main barriers to uptake.
