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].