Generics

US lawmakers question FDA on complex generics approvals

Generics/General | Posted 28/02/2020

A US Congress Committee have sent a letter to the US Food and Drug Administration (FDA) regarding concerns over the approval of complex generics.

EMA recommends four new generics

Generics/News | Posted 21/02/2020

At the Committee for Medicinal Products for Human Use’s (CHMP) January 2020 meeting, the Committee recommended four new generics, and one new biosimilar, for approval.

Russian drug shortages at ‘crisis point’

Generics/General | Posted 21/02/2020

Russia has been facing limited access to foreign pharmaceutical products for several years, but recent reports suggest drug shortages are reaching ‘crisis point’.

Irish pharmaceutical association urges political parties to create a new medicines policy

Generics/General | Posted 14/02/2020

The Irish Pharmaceutical Healthcare Association (IPHA) has urged political parties to mandate new policy to increase access to medicines ahead of the Irish general election, which was held on 8 February 2020.

Generics applications under review by EMA – January 2020

Generics/General | Posted 07/02/2020

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].

FDA approves generics for cancer and gout

Generics/News | Posted 31/01/2020

The US Food and Drug Administration (FDA) has approved two generic versions of Novartis’ anticancer drug Afinitor (everolimus), alongside a generic of Takeda’s gout treatment Uloric (febuxostat).

FDA sets up centre to improve quality of compounded drugs

Generics/General | Posted 24/01/2020

The US Food and Drug Administration (FDA) has established a Center of Excellence to improve the quality of compounded drugs, which are created by combining two or more drugs and are not FDA-approved.

Medicare Part D has no impact on generics prescribing in long-term care

Generics/Research | Posted 17/01/2020

A recent observational study [1] in long-term care facilities in the US shows that the Medicare Part D programme has no significant effect on the rate of generic drug prescriptions, contrary to expectations.

FDA approves MS and prostate generics

Generics/News | Posted 17/01/2020

The US Food and Drug Administration (FDA) in December 2019 approved the first generics of Gilenya (fingolimod) for multiple sclerosis (MS) and Rapaflo (silodosin) for benign prostatic hyperplasia.

American College of Physicians makes new recommendations to cut drug spending

Generics/Research | Posted 10/01/2020

A paper from the American College of Physicians (ACP) makes a number of policy recommendations to reduce costs of prescription drugs in the US, including annual caps for out-of-pocket spending and negotiating with manufacturers [1].

The impact of generics regulation in Brazil

Generics/Research | Posted 13/12/2019

Sales of originator drugs have decreased and the number of generics manufacturers have increased following the introduction of the Brazilian Generics Law, reports a new study [1].

Ontario proposes regulatory changes to simplify drug formulary listing and cut government payments to pharmacies

Generics/General | Posted 13/12/2019

Following a number of changes in Canada’s generics and biosimilars landscape in 2019 [1-3], the Ontario Ministry of Health and Long-Term Care (the Ministry) is proposing a number of changes to streamline drug formulary listing and reduce the payments it makes to pharmacies for dispensing drug benefits.

WHO prequalifies antiparasitic API

Generics/General | Posted 06/12/2019

The World Health Organization (WHO) has announced the prequalification of Pyrimethamine, manufactured by Macleods Pharmaceuticals Ltd, as an active pharmaceutical ingredient (API).

EMA recommends approval for two new generics

Generics/News | Posted 06/12/2019

The European Medicines Agency’s (EMA) human medicines committee recommended seven new medicines for approval at its November 2019 meeting, including two generics: clopidogrel/acetylsalicylic acid and deferasirox.

FDA generics approvals increasing but not for at-risk generics

Generics/Research | Posted 29/11/2019

Analysis of generics approvals by the US Food and Drug Administration (FDA) reveals a slight increase in the total number of applications approved between 2016 and 2018. Over 1,800 applications were approved in this time, however, there was no significant change to the proportion of these drugs in shortage or with limited competition [1].

FDA identifies causes of drug shortages, recommends solutions

Generics/General | Posted 22/11/2019

In response to growing concern over drug shortages, the US Food and Drug Administration (FDA) has released a report and accompanying statement regarding causes and solutions for the problem.

Dubai’s LIFEPharma signs historic agreement with Canada’s Apotex

Generics/News | Posted 22/11/2019

LIFEPharma, a wholly-owned subsidiary of the United Arab Emirates (UAE)-headquartered VPS Healthcare, has announced a historic agreement with Apotex Inc, Canada’s largest producer of generic drugs.

Safety of generics in US questioned

Generics/Research | Posted 15/11/2019

US Food and Drug Administration (FDA) regulations guarantee a safe drug supply. However, author Michael White, from the Health Outcomes, Policy, and Evidence Synthesis Group, University of Connecticut School of Pharmacy, Connecticut, USA, questions the safety of foreign generic drug imports [1].