Generics

EMA launches European shortages monitoring platform to tackle persistent medicine shortages

Generics/General | Posted 03/12/2024

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

Generics/Research | Posted 23/10/2024

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

Generics/Research | Posted 22/05/2024

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

Generics/News | Posted 06/02/2024

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

Generics/Research | Posted 23/01/2024

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

Generics/General | Posted 14/09/2023

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

Generics/Research | Posted 08/09/2023

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

Generics/Research | Posted 10/08/2023

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

Generics/Research | Posted 20/06/2023

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

Generics/General | Posted 27/04/2023

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

Generics/Research | Posted 06/04/2023

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

Generics/Research | Posted 10/02/2023

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

Generics/Research | Posted 12/12/2022

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

Generics/General | Posted 28/10/2022

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

Generics/News | Posted 21/10/2022

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

Generics/Research | Posted 02/09/2022

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

Generics/Research | Posted 26/08/2022

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

Generics/General | Posted 26/08/2022

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

Generics/General | Posted 08/07/2022

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

Generics/Research | Posted 01/07/2022

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

Generics/General | Posted 24/06/2022

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?

Generics/Research | Posted 17/06/2022

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

Generics/General | Posted 10/06/2022

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?

Generics/Research | Posted 10/06/2022

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/Research | Posted 03/06/2022

Generics are favoured by healthcare providers due to a variety pf reasons, according to author Roy G Beran [1].

UK NHS faces drug shortages

Generics/General | Posted 27/05/2022

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

Generics/Research | Posted 27/05/2022

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

Generics/Research | Posted 20/05/2022

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

Generics/Research | Posted 16/05/2022

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

Generics/Research | Posted 06/05/2022

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

Generics/News | Posted 22/04/2022

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

Generics/General | Posted 15/04/2022

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

Generics/News | Posted 15/04/2022

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.