Generics
FDA forms working group to increase generics competition
US Food and Drug Administration (FDA) Commissioner Dr Scott Gottlieb had announced the creation of a working group of senior staff focused on increasing generic drug competition.
Indivior to appeal US ruling on opioid addiction patent
UK-based addiction treatment manufacturer Indivior Plc have announced plans to appeal against a US court, which ruled that Indian generics manufacturer Dr Reddy’s Laboratories (Dr Reddy’s) had not infringed patents on their opioid addiction treatment Suboxone.
Generics applications under review by EMA – August 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].
Mylan launches three HIV generics in Canada
US generics giant Mylan Pharmaceuticals (Mylan) announced on 10 August 2017 that it had launched three generic HIV drugs in Canada, after having received final approval for the products from Health Canada.
Teva launches generic testosterone
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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 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
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.
FDA approves Akorn’s mycophenolate mofetil following Form 483 resolution
US-based generic pharmaceutical manufacturer, Akorn Inc has announced that its sterile manufacturing site in Decatur, Illinois, USA has received a No Action Indicated (NAI) status from the US Food and Drug Administration (FDA). This is following the sites re-inspection in December 2016.
Evolution of scientific research on generic drugs
A review of peer-reviewed scientific articles carried out in January 2013 on generic drugs published on PubMed/MEDLINE from the date of the first published article on generics (1954) to 2012 was undertaken by Lucas-Dominguez et al. (2016) to establish the current status of research in this area. According to the authors, this is the first study to evaluate evolution of research on generic drugs.
Generic antidepressant launched in the US
US pharma giant Pfizer is facing competition for its antidepressant Pristiq (desvenlafaxine) with generics hitting the market in the US.
Potency of generics of piperacillin/tazobactam
In an era of increasing bacterial resistance, the potency of antibiotics is critical. Researchers from the Tata Medical Centre, Kolkata, India tested the relative potency of different generic brands of the piperacillin/tazobactam antibiotic [1].
Delaying generics using citizen petitions
A study of citizen petitions submitted to the US Food and Drug Administration (FDA) over the last 12 years finds that such petitions are being used by drug companies ‘in a last-ditch effort to hold off competition’ [1].
FDA approves rare disease deflazacort at exorbitant price
Deflazacort is a steroid treatment that has long been approved in many countries outside the US. In February 2016, the US Food and Drug Administration (FDA) approved Marathon Pharmaceuticals’ deflazacort (Emflaza) for the treatment of Duchenne muscular dystrophy. However, it is reported that the drug will come with a devastating price-tag of US$89,000 a year, far more than prices charged abroad.
Promoting and regulating generics in Brazil
Generic drug substitution constitutes a core instrument of countries’ strategies to reduce the price of drugs and expand access to health care. To that end, scholars and international organizations have encouraged adoption of a range of policy instruments that countries can use to promote the use of generics, focusing on measures to increase both the demand for and supply of such products.
Generic lung cancer treatment now available in China
A generic version of AstraZeneca’s Iressa (gefitinib) has been released onto the market in China. This generic drug is being marketed under the brand name Yiruike and is produced by Chinese pharmaceutical company, Qilu Pharmaceutical (Qilu).
Rising costs of cancer treatments not matched by clinical efficacy
The high prices of new cancer treatments are a major barrier to access in low-income countries and placing growing pressure on developed countries. In their study, author Hill et al. estimated the lowest possible treatment costs for four new cancer drugs, showing that manufacturing of generics alternatives could significantly reduce treatment costs [1].
Malaysian Government approves new generics facility
Bangladesh-based generics firm Beximco Pharmaceuticals (Beximco) has made a deal with Malaysia’s BioCare Manufacturing (BioCare) to manufacture and supply differentiated medical products in the country.
US approves generic of narcolepsy drug Xyrem
The US Food and Drug Administration (FDA) has approved the first generic version of Xyrem (sodium oxybate) – the only drug approved to treat the sudden muscle weakness seen in narcolepsy.
Generics and brand-name drugs compared
What differentiates generics from brand-name medications? That is a question that Andrea Bakker from the Faculty of Medicine of the University of Ottawa tried to answer [1]. In her commentary she explored how differences in licensing affect drug efficacy and how the pharmaceutical landscape in Canada affects patient care.
Novo Nordisk becomes second pharma company to cap price hikes
Danish pharmaceutical company Novo Nordisk has pledged to limit the price rises of their drugs to single digit increases each year, following the commitment made by Allergan in September 2016.
Switching stable kidney transplant patients to generic tacrolimus safe
Researchers from Chile have found that switching stable kidney transplant patients to generic tacrolimus is safe. However, they caution the transplant community to carefully monitor any switch to generics [1].
Patent and regulatory exclusivities driving generic and follow-on market availability
Daniel Nam reviews the differences between intellectual property exclusivity (patents) and regulatory exclusivities (market exclusivity) in the US [1]. A patent is a grant of property right to an inventor for 20 years from the date of application. Market exclusivity is awarded to manufacturers of first-to-market brand products and excludes other manufacturers from marketing the drug product for a certain period of time, depending on the type of product. Nam explains that these tools are used by the US Food and Drug Administration (FDA) to achieve a balance between innovation and equitable access to medications.
Generics regulators outline priorities to 2020
The International Generic Drug Regulatory Programme (IGDRP) announced on 21 December 2016 that it had released its ‘Roadmap to 2020’, which outlines the group’s priorities until 2020. The document outlines those priorities as including five initiatives geared toward harmonizing global regulations for generics.
Endo launches generic version of Zetia
Ireland-based Endo International plc has announced that its operating company Par Pharmaceutical will ship the first generic version of Merck & Co’s blockbuster cholesterol medication Zetia.
Generics applications under review by EMA – December 2016
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].
Natco Pharma and Alvogen launch first US Tamiflu generic
Natco Pharma (Natco) and their marketing partner Alvogen have launched the first generic equivalent of Roche’s flu treatment Tamiflu (oseltamivir phosphate) in the US.
UK competition authority accuses Actavis of overcharging NHS
The UK’s Competition and Markets Authority (CMA) has accused Actavis of breaching competition law by increasing the price of generic hydrocortisone tablets by more than 9,500−12,000% compared to the brand-name product, which was sold by a different company prior to April 2008.
Mylan launches generic EpiPen
US-based drugmaker Mylan announced on 16 December 2016 that it had launched the authorized generic version of its EpiPen (epinephrine) injectors at a wholesale price of US$300 per two-pack. This price, the company says, ‘is more than 50% lower’ than the brand-name price.
Competition does not curb high drug prices
With increasing concern over price increases for medicines a new concern being raised is that increased competition in the pharma industry does not always lead to lower prices.
Lupin and Natco’s Armodafinil generic approved to treat sleep disorders by FDA
The US subsidiary of Indian drug manufacturer, Lupin Pharmaceuticals, announced on 29 November 2016 that its Armodafinil tablets had received approval from the US Food and Drug Administration (FDA). Marketing and promotion of the product in the US will begin shortly.
Addressing patient misconceptions about generics
In the face of increasing drug costs, substitution by generics is often used as a strategy by healthcare systems to rein in expenditure. However, patient misconceptions about generics can hinder such substitutions. Researchers Sanchez and Zurek discuss how pharmacists can improve this situation by educating patients on the use and safety of generics [1].
FDA reports record number of generics approvals
The US Food and Drug Administration’s (FDA) Office of Generic Drugs (OGD) latest activity report shows an increase in approvals for generics, including 835 tentative or full approvals issued for the fiscal year (FY) 2016.
Mylan to make generic hepatitis drug under MPP sublicence
Generics giant Mylan Pharmaceuticals (Mylan) announced on 28 November 2016 that the company had signed a sublicence with the Medicines Patent Pool (MPP) to make a generic of Bristol-Myers Squibb’s hepatitis C medicine Daklinza (daclatasvir).
Policies to address price rises in old generics
Old, off-patent drugs are becoming increasingly expensive. But how can policymakers address the problem? Naren P Tallapragada from the Harvard Medical School discusses the underlying causes of the high-cost off-patent drug problem and proposes some policy solutions that could address the problem [1].
First prequalification submissions for generic dolutegravir
The Medicines Patent Pool (MPP) announced on 10 November 2016 that two of its generics manufacturing partners are the first companies to apply for prequalification of generic dolutegravir, a new antiretroviral that the MPP licensed from ViiV Healthcare in 2014.
Therapeutic substitution could save Americans US$73 billion
Therapeutic substitution could save the America healthcare system US$73 billion and patients US$24.6 billion in out-of-pocket expenses, according to US researchers [1].
Dr Reddy’s makes deal with Gland Pharma for US injectables
Generics manufacturer Dr Reddy’s Laboratories (Dr Reddy’s) announced on 26 October 2016 that it had entered into a ‘strategic collaboration’ with India-based sterile dosage form maker Gland Pharma.
Transparency in the Australian pharmaceutical industry
In Australia, the promotion of medicines to healthcare professionals is controlled by self-regulatory schemes operated by the pharmaceutical industry.
Factors affecting generics entry
Edward Kong, Research Assistant at the Yale University, Department of Economics, carried out a study into the factors that influence a generics maker’s decision to enter a specific market [1].
Sandoz petitions FDA over requirements for generics of Advair Diskus
Sandoz has asked the US Food and Drug Administration (FDA) not to approve generics of GlaxoSmithKline’s (GSK) chronic obstructive pulmonary disorder (COPD) treatment Advair Diskus (fluticasone/salmeterol), unless the generics applications contain the results of pharmacokinetic (PK) bioequivalence studies that ‘ensure the safety and efficacy’ of the products.
Teva sells Actavis’ UK and Ireland generics business to Intas
Israeli generics giant Teva Pharmaceutical Industries (Teva) announced on 5 October 2016 that it had agreed to sell the UK and Ireland generics business of Actavis to Accord Healthcare (a subsidiary of Intas Pharmaceuticals) for GBP 603 million, subject to final approval from the European Commission (EC).
Competition in the generics industry
In theory, an increase in the use of generics should help to reduce overall drug expenditures. However, growth in spending on medicines in the US increased by US$46.2 billion, or 12.2%, over 2014 levels, reaching US$425 billion in 2015 [1]. This increase comes despite a simultaneous growth in spending on generics, which increased by US$7.9 billion (7.4%) to US$114.1 billion in 2015.
Mylan agrees to pay fine over EpiPen rebates
US-based drugmaker Mylan announced on 7 October 2016 that it had agreed to pay US$465 million to the US Department of Justice (DOJ) and other government agencies. The agreement, the company says, will resolve questions that have been raised about the classification of its EpiPen injectors for the Medicaid Drug Rebate Program. The deal has also been made without the company having to admit any wrongdoing.
Generic antibiotics could be contributing to bacterial resistance
Therapeutic non-equivalence of generic antibiotics could be contributing to the global problem of bacterial resistance, according to researchers from the Universidad de Antioquia in Colombia.
Teva recalls antibiotic and anti-seizure drug
Recent US Food and Drug Administration (FDA) reports have caused Israeli generics producer Teva Pharmaceutical Industries (Teva) to recall a treatment for seizures, as well as an antibiotic made at its sterile manufacturing plant in Hungary.
Different approaches to bioequivalence trials for EMA evaluation
Selection of robust bioequivalence study designs is a difficult task for manufacturers of generics. Author Nathaniel Refalo from the Malta Medicines Authority and colleagues therefore investigated whether different approaches in various products assessed by the European Medicines Agency (EMA) during the approval phase resulted in a reduction in the resources required to show bioequivalence [1].
Why do generic drug prices keep on rising?
Consumers are paying more and more for their drugs, and especially in the US. The US allows manufacturers to set their own prices for drugs, leading to overall medicine costs being higher than anywhere else. More and more, insurance companies are passing on these higher costs to consumers.
