Generics

FDA approves Akorn’s mycophenolate mofetil following Form 483 resolution

Generics/News | Posted 07/04/2017

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

Generics/Research | Posted 31/03/2017

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

Generics/News | Posted 31/03/2017

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

Generics/Research | Posted 24/03/2017

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

Generics/Research | Posted 17/03/2017

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

Generics/News | Posted 17/03/2017

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

Generics/Research | Posted 10/03/2017

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

Generics/News | Posted 10/03/2017

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

Generics/Research | Posted 03/03/2017

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

Generics/General | Posted 03/03/2017

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

Generics/News | Posted 24/02/2017

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

Generics/Research | Posted 17/02/2017

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

Generics/General | Posted 17/02/2017

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

Generics/Research | Posted 10/02/2017

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

Generics/Research | Posted 03/02/2017

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

Generics/General | Posted 27/01/2017

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

Generics/News | Posted 27/01/2017

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

Generics/General | Posted 20/01/2017

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].

Natco Pharma and Alvogen launch first US Tamiflu generic

Generics/News | Posted 20/01/2017

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

Generics/General | Posted 13/01/2017

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

Generics/News | Posted 13/01/2017

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

Generics/General | Posted 06/01/2017

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

Generics/News | Posted 06/01/2017

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

Generics/Research | Posted 02/12/2016

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

Generics/General | Posted 02/12/2016

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/News | Posted 02/12/2016

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

Generics/Research | Posted 25/11/2016

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

Generics/General | Posted 25/11/2016

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

Generics/Research | Posted 18/11/2016

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/News | Posted 18/11/2016

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

Generics/Research | Posted 11/11/2016

In Australia, the promotion of medicines to healthcare professionals is controlled by self-regulatory schemes operated by the pharmaceutical industry.

Factors affecting generics entry

Generics/Research | Posted 04/11/2016

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

Generics/General | Posted 04/11/2016

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

Generics/News | Posted 28/10/2016

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

Generics/Research | Posted 21/10/2016

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

Generics/News | Posted 21/10/2016

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.