Generics

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.