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Generics/General

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Generics approvals remain high in US in 2019

Generics/General | Posted 10/04/2020

In February 2020, the US Food and Drug Administration’s (FDA) Office of Generic Drugs released their 2019 Annual report which highlighted the year’s key achievements. The report stated that in 2019, the Office of Generic Drugs (OGD) facilitated 1,014 generic drug final and tentative approvals. This is slightly lower than the 1,021 approvals of 2018 but remains high enough to make a positive contribution to the FDA’s generic drug programme.

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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.

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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’.

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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.

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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].

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Generics applications under review by EMA – July 2019

Generics/General | Posted 02/08/2019

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].

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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.

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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.

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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).

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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.

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UK Labour Party proposes state run generics manufacturer

Generics/General | Posted 25/10/2019

In a speech at the 2019 Labour Party Conference, leader Jeremy Corbyn introduced the ‘Medicines For The Many’ initiative, which aims to put ‘public health before private profit’ and includes plans to establish a state-owned pharmaceutical company to manufacture generic medicines in the UK.

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Ranitidine recalls escalate as FDA declares ‘unacceptable’ levels of NDMA in the drug

Generics/General | Posted 18/10/2019

On 2 October 2019, the US Food and Drug Administration (FDA) declared that it had found ‘unacceptable’ levels of the probable human carcinogen N-nitrosodimethylamine (NDMA) in the heartburn drug Zantac (ranitidine) and its generic versions.

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Carcinogen contamination halts distribution of generic Zantac

Generics/General | Posted 04/10/2019

Heartburn drug Zantac (ranitidine) is being taken off markets worldwide following findings that the medications may be contaminated with cancer-causing agents.

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FDA’s global inspection strategy strengthened

Generics/General | Posted 20/09/2019

The US Food and Drug Administration (FDA) has implemented a modernized approach to ensure the safety and quality of globally produced innovator and generic medicines. Through its Program Alignment, FDA’s Office of Regulatory Affairs has modernized its workforce and approach to improving public health to keep up with globalization and increasingly complex supply chains. Since FDA implemented Program Alignment in 2017, the regulation of generic medicines has become increasingly strategic, risk-based and efficient.

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China issues list of generics needed in the country

Generics/General | Posted 30/08/2019

Authorities in China have introduced an initiative which the country hopes will boost the development of generics by encouraging pharmaceutical companies to develop and produce them.

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Gilead’s Truvada will face generics competition in 2020

Generics/General | Posted 19/07/2019

Gilead Sciences’ HIV blockbuster Truvada will face generics competition in the US in 2020, a year earlier than expected.

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Pharmacy benefit managers use spread pricing to increase profits in Michigan

Generics/General | Posted 07/06/2019

A report released in April 2019 raises new questions about the role of Pharmacy Benefit Managers (PBMs) in Michigan, specifically their use of spread pricing to increase profits at the expense of pharmacists, taxpayers and patients.

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Multi-state lawsuit alleges widespread generic price fixing in the US

Generics/General | Posted 17/05/2019

A sweeping lawsuit filed on 10 May 2019 by over 40 US states alleges that a number of major drug companies conspired to inflate the prices of generic drugs by as much as 1,000%.

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US Court rejects Teva’s lawsuit over generic Restasis

Generics/General | Posted 26/04/2019

The US District Court for the District of Columbia has discarded lawsuits from generics giant Teva Pharmaceutical Industries (Teva) regarding its first-to-file exclusivity rights on a generic version of the blockbuster dry eye drug Restasis (cyclosporine).

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FDA releases statement on generic drug quality

Generics/General | Posted 12/04/2019

A statement released by the US Food and Drug Administration (FDA) responds to recent press reports of quality issues and outlines the Agency’s ongoing efforts to maintain the quality of generic drugs manufactured both in the US and overseas.