Generics

Teva launches generic testosterone

Generics/News | Posted 08/09/2017

Teva Pharmaceutical Industries (Teva) has announced the exclusive launch of generic testosterone, previously marketed as Axiron by Eli Lilly and Co, on the US market.

Barriers to generics substitution in the Middle East

Generics/Research | Posted 01/09/2017

Although most pharmacists in Lebanon are in favour of generic drug substitution, fewer than half have actually implemented the policy, according to a study carried out by researchers from the American University of Beirut [1].

FDA receives record number of generic drug applications for 2017

Generics/General | Posted 01/09/2017

Just part way through 2017, the US Food and Drug Administration (FDA) has already received a record number of generic drug applications, surpassing the totals for both 2016 and 2015.

Generic drug substitution in Lebanon

Generics/Research | Posted 25/08/2017

A new study reports on Lebanon’s recently introduced generic drug substitution and unified prescription policy, a country which spends among the most on pharmaceuticals in the Middle East. The study explored attitudes of community pharmacists towards the idea of the policy and its current implementation [1].

Senior US senator calls on insulin manufacturers to justify high prices

Generics/General | Posted 25/08/2017

Senator Amy Klobuchar, senior senator from Minnesota, has written to three major diabetes drug manufacturers asking them to justify recent price hikes, which are placing increasing pressure on patients in the US.

Adamis gains FDA approval for its EpiPen rival

Generics/News | Posted 25/08/2017

Adamis Pharmaceuticals Corporation (Adamis) announced in June 2017 that they have received US Food and Drug Administration (FDA) approval for their EpiPen competitor Symjepi.

WHO prequalifies first generic hepatitis C drug

Generics/General | Posted 18/08/2017

The World Health Organization (WHO) has prequalified the first generic drug to treat hepatitis C. The antiviral agent sofosbuvir will be manufactured at a lower cost by Mylan.

Endo removes Opana ER opioid from the market

Generics/News | Posted 18/08/2017

The US Food and Drug Administration (FDA) requested that Endo International plc (Endo) remove its opioid medication Opana ER from the market, due to concerns over the ‘public health consequences of abuse’.

Generics prices increase when competition decreases

Generics/Research | Posted 11/08/2017

A US-based retrospective cohort study has found that generics prices increase when competition is low or non-existent [1].

AAM tries to block ‘unconstitutional’ drug pricing law

Generics/General | Posted 11/08/2017

The Association for Accessible Medicines (AAM) has filed a lawsuit against the Attorney General of Maryland in an attempt to block a recently passed law which could affect national commerce in the US and harm the market for generic drugs, which saved Maryland over US$4 billion in 2016.

Impax launches new high-strength ADHD generics

Generics/News | Posted 11/08/2017

Impax Laboratories Inc (Impax) has received US Food and Drug Administration (FDA) approval for additional strength capsules of generic Focalin XR (dexmethylphenidate hydrochloride), which was originally marketed by Novartis and is used to treat attention deficit hyperactivity disorder (ADHD).

Follow-up study finds generic tacrolimus safe for kidney transplant patients

Generics/Research | Posted 14/07/2017

Researchers from Portugal, who carried out a long-term follow-up study, have found that switching stable kidney transplant patients to generic tacrolimus is safe [1].

Generics in the pipeline for 2017 in the US

Generics/Research | Posted 07/07/2017

Since the Hatch-Waxman Act was passed in 1984, the approval process for generics has been simplified. The law created an abbreviated approval pathway for generics making it easier for generics to enter the market and expanding access to important — often life-saving — drugs.

FDA lists drugs without generics to increase competition

Generics/General | Posted 07/07/2017

The US Food and Drug Administration (FDA) announced on 27 June 2017 that it had taken ‘two new, important steps’ to increase competition and encourage the entry of generics in the US.

UK introduces new law to control generic drug prices

Generics/General | Posted 30/06/2017

A new law introduced in the UK is seeking to clarify and extend the government’s powers to regulate the cost of medicines and medical supplies and to collect sales and pricing information from pharmaceutical companies.

Baxter and Dorizoe make deal for generic injectables

Generics/General | Posted 23/06/2017

US-based healthcare company Baxter International (Baxter) and contract research and development organization Dorizoe announced on 14 June 2017 that they have made a deal for generic injectables.

FDA approval for generics of ADHD drug Strattera

Generics/News | Posted 23/06/2017

The US Food and Drug Administration announced on 30 May 2017 the approval of the first generic versions of Strattera (atomoxetine).

FDA targets rising drug prices by increasing generics competition

Generics/General | Posted 16/06/2017

US Food and Drug Administration (FDA) Commissioner Scott Gottlieb is advocating reducing drug costs by approving cheaper generics faster.

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.