Generics

FDA approves two new Seroquel XR generics

Generics/News | Posted 16/06/2017

The US Food and Drug Administration (FDA) has approved two generic versions of Astra Zeneca’s antidepressant Seroquel XR, which has a billion-dollar market in the US.

Oncology drug pricing – the case of generic imatinib

Generics/Research | Posted 09/06/2017

Authors Christopher Chen and Aaron Kesselheim review how various market strategies slowed the entry of generics of leukaemia treatment Gleevec (imatinib) in the US [1].

Japan plans to increase generics use

Generics/General | Posted 09/06/2017

Japan is currently the world’s second largest pharmaceutical market. Prescription brand-name drugs dominate the market and generics constitute only around 56% of total sales. However, the Japanese Government wants to change that.

Generic substitution of antiretroviral drugs in Ireland: healthcare provider views

Generics/Research | Posted 02/06/2017

A survey conducted in Ireland shows that most healthcare providers consider the generic substitution of antiretroviral drugs acceptable, although concerns remain about dosing frequency [1].

Call to phase out branded drugs in India

Generics/General | Posted 02/06/2017

Doctor and patient associations have come together to suggest that the Indian Government phase out branded generics and ban differential pricing under different brands to promote generic drug prescriptions.

Generics substitution of antiretroviral drugs in Ireland: patient views

Generics/Research | Posted 26/05/2017

Researchers in Ireland report the findings of a survey of opinions on the generics substitution of antiretroviral (ARV) drugs [1], revealing that over 70% of patients would have no concerns about their use.

Vytorin generic launched in the US

Generics/News | Posted 26/05/2017

The US Food and Drug Administration (FDA) has approved a generic version of the anti-cholesterol drug Vytorin, which will be launched on the US market by Impax Laboratories Inc (Impax).

Generics and biosimilars: status in the EU

Generics/General | Posted 26/05/2017

According to Medicines for Europe, without generic medicines Europe would have paid Euros 100 billion more for its medicines in 2014 alone. In a recent interview, the Association’s President Jacek Glinka spoke about the central issues surrounding the affordability and accessibility of medicines in the region.

Concerns over change to generics prescribing in Australia

Generics/General | Posted 19/05/2017

In its 2017 budget, Australia is set to make changes that will encourage the use of generics and that are estimated could save the country AU$1.8 billion.

Generics applications under review by EMA – April 2017

Generics/General | Posted 12/05/2017

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].

Reference pricing for generics in Switzerland

Generics/Research | Posted 04/05/2017

In 2016, the Swiss Federal Office for Health (FOH) planned to modify the reference pricing scheme for generics. Rather than using a copayment of 10 per cent on low-cost and a 20 per cent copayment on high-cost generics, it was to set the benchmark at the 25th percentile of the price distribution and make patients pay out of pocket for the full excess of price over this benchmark in addition to a basic 10 per cent copayment. This paper, based on an expert report commissioned by Intergenerika, the Swiss association of manufacturers and importers of generics and biosimilars, purports to answer the question of whether this modification is apt to improve the performance of the Swiss healthcare system [1].

First Advair generic launched in the US

Generics/News | Posted 04/05/2017

Teva Pharmaceutical Industries (Teva) has announced the launch of AirDuo RespiClick and its authorized generic, the first competitor to GlaxoSmithKline's (GSK) best-selling asthma drug Advair in the US.

Approaches to assure quality and improve patient perceptions of generics in Japan

Generics/Research | Posted 28/04/2017

The rapidly ageing population in Japan has led the government to promote the use of generics in the universal health insurance system. This article provides an overview of the regulatory approaches available to confirm the quality of generics and achieve greater acceptance of these products by patients [1].

Patent challenges hit Actavis and Acorda

Generics/News | Posted 28/04/2017

Teva Pharmaceuticals’ subsidiary Actavis and neurological drug specialist Acorda Therapeutics have both faced patent challenges recently over treatments for acne and multiple sclerosis, respectively.

Significant price reductions possible for new cancer drugs

Generics/Research | Posted 21/04/2017

Generic production could drastically reduce the prices of novel cancer drugs and make treatments accessible to thousands more people each year, according to a study by Hill et al. [1].

Indian drug industry faces setbacks in Europe and the US

Generics/General | Posted 21/04/2017

The European Medicines Agency (EMA) has announced that they have recommended the suspension of generic drug approvals and drug applications of over 300 drugs. This is due to unreliable bioequivalence studies carried out by the Indian contract research firm Micro Therapeutic Research Labs.

Generics could cut costs of cancer drugs by over 99%

Generics/Research | Posted 14/04/2017

Generics manufacturing and import of novel cancer drugs could massively reduce their costs in the UK, according to a study by Hill et al.[1].

FDA commits to success of the generic and biosimilar second-generation user fee acts

Generics/General | Posted 14/04/2017

Representatives of the Centre for Drug Evaluation and Research (CDER), the Association of Accessible Medicines (AAM), the Biotechnology Innovation Organisation (BIO) and the Biosimilars Council Director reportedly testified on 8 March 2017 as to their commitment to the US Food and Drug Administration’s (FDA) recommendations for the second generation of user fee agreements covering both generics and biosimilars.