Generics

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.

Revlimid (lenalidomide) generics launch across Europe

Generics/News | Posted 01/04/2022

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

Generics/General | Posted 01/04/2022

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

Generics/News | Posted 25/03/2022

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

Generics/General | Posted 18/03/2022

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

Generics/Research | Posted 04/03/2022

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

Generics/News | Posted 25/02/2022

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

Generics/News | Posted 18/02/2022

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

Generics/General | Posted 04/02/2022

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

Generics/General | Posted 28/01/2022

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

Generics/General | Posted 21/01/2022

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.