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].

Generics transition brings economic benefits to Canada

Generics/Research | Posted 08/11/2019

Economic analysis of genericization of cancer medicines in Canada has confirmed their cost-effectiveness. This rare example of an economic evaluation of the benefits of generics was published in Current Oncology [1].

Glenmark and Lupin gain FDA approval for nervous system agents

Generics/News | Posted 08/11/2019

Indian generics maker Glenmark Pharmaceuticals has been granted tentative US Food and Drug Administration (FDA) approval for its multiple sclerosis (MS) generic, while generics giant Lupin Ltd has also received FDA approval for its Dilantin generic, an anti-seizure medication.

A call for economic reassessment of drug regimens

Generics/Research | Posted 08/11/2019

Canadian researchers have called for the cost-effectiveness of drug products to be routinely reassessed. Their study, published in Current Oncology [1], has shown that cost-effectiveness of products alters significantly after generics are introduced. This has big implications for healthcare budgets and access to medicines, in Canada and worldwide.

Pharmacy chain drives choice among US generics manufacturers

Generics/Research | Posted 25/10/2019

A recent study shows that the dispensing pharmacy chain is a strong driver of generics manufacturer choice in the US, which could have implications for economic models of the generic drugmarket [1].

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.

First pregabalin generics approved by FDA

Generics/Research | Posted 18/10/2019

In July 2019, the US Food and Drug Administration (FDA) approved multiple applications for the first generics of Lyrica (pregabalin) for the management of fibromyalgia, postherpetic neuralgia, neuropathic pain associated with diabetic peripheral neuropathy or spinal cord injury, and as adjunct therapy for partial-onset seizures in patients aged 17 years or over.

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.

Strong generics nocebo effect found in US

Generics/Research | Posted 11/10/2019

In the US, generic drug products account for approximately 90% of all prescriptions dispensed [1]. Despite this, there is a continued lack of trust in these drug products. Generics are often perceived as less effective and less safe than their brand-name reference products. Now, researchers at Brigham and Women’s Hospital and Harvard Medical School have confirmed that in the US, generics exhibit a strong nocebo effect. Here, negative bias against generics leads to negative clinical outcomes [2]. The researchers call for more education about generics to increase awareness of their benefits and increase access to these lower-priced medicines.

Alimta and Orfadin generics approved by FDA

Generics/News | Posted 11/10/2019

The US Food and Drug Administration (FDA) has tentatively approved Mylan’s pemetrexed, a generic version of Eli Lilly’s cancer drug Alimta, and approved Novitium Pharma’s generic equivalent of Swedish Orphan Biovitrum's Orfadin (nitisinone capsules).

New evidence: comparable clinical outcomes for generic and brand medications

Generics/Research | Posted 04/10/2019

New research carried out at Brigham and Women’s Hospital and Harvard Medical School, provides additional evidence that shows generic and brand-name drugs have comparable clinical outcomes [1].

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.

Evaluating success: generics substitution policy in Chile

Generics/Research | Posted 27/09/2019

The effectiveness of Chile’s 2014 generics substitution policy has been assessed by an international team of researchers. In their BMJ Global Health [1] article, the authors reveal that, although there has been a decrease in the uptake of expensive originator drugs, this is not mirrored by an increase in the uptake of less expensive bioequivalent products. This shows that further work is needed to help increase the uptake of generics in Chile.

EMA approves leukaemia and multiple myeloma generics

Generics/News | Posted 27/09/2019

The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) announced on 20 September 2019 that it had recommended granting marketing authorization for hypertension and leukaemia and multiple myeloma generics.

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.

Generics in Chile: policy success but promotion required

Generics/Research | Posted 20/09/2019

A first-time evaluation [1] of Chile’s generics substitution policy has shown that there has been a decrease in sales of branded originator medicines since policy implementation in 2014. However, this was not mirrored by an increase in sales of the corresponding generic drug products. The BMJ Global Health [1] article authors note that, to improve access to medicines in Chile, more work needs to be done to promote the uptake of generics.

TRIPS flexibilities: current and future use in the SADC region

Generics/Research | Posted 13/09/2019

In response to the HIV/AIDS crisis of the late 1990s, several legal options were introduced to facilitate access to lower-cost treatments. These included flexibilities in the World Trade Organization (WTO) Trade-Related Aspects of Intellectual Property Rights (TRIPS) Agreement, known as ‘TRIPS flexibilities’. In a recent review, authors ‘t Hoen, Kujinga and Boulet describe TRIPS flexibilities and discuss their current and future use in the Southern African Development Community (SADC) region [1].

Improving access to medicines: the Doha Declaration on the TRIPS Agreement

Generics/Research | Posted 06/09/2019

In a recent review, authors ‘t Hoen, Kujinga and Boulet describe the role of the Doha Declaration on the World Trade Organization (WTO) Trade-Related Aspects of Intellectual Property Rights (TRIPS) Agreement in improving access to essential medicines [1].

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.