Generics

Pharmaceutical pricing and reimbursement policies

Generics/Research | Posted 11/12/2015

A recurrent challenge in health policy is to ensure equitable access to safe and effective medicines. In recent years, access to medicines, in particular to high-cost medicines, has become a major challenge for payers in all countries including high-income economies. Factors that challenge the financial sustainability of publicly funded health and pharmaceutical systems include demographic and epidemiological developments, a tightening of public health budgets due to overall economic pressures, e.g. the global financial crisis, and the need of public payers to consider covering new medicines, some of which come with premium prices [1].

Policies to lower prices of generics in Austria and Finland

Generics/Research | Posted 04/12/2015

In this era of austerity many governments have introduced policies aimed at reducing the price of generics. In Austria, measures taken to reduce the cost of medicines include generic price linkage. While in Finland generics substitution and reference pricing have been introduced.

Prescribing and dispensing generics in Japan

Generics/Research | Posted 27/11/2015

Drug costs in Japan have been found to be much greater than the average of industrialized nations, which means that too many wasteful prescriptions are written for pharmaceuticals. This has been attributed to attempts by medical institutions to increase revenues by prescribing unnecessary medicines to patients. To curb this trend, the government has pushed forward with the lowering of government-set prices for prescription drugs and the separation of medical and dispensary services in its national health programme, which was implemented in 1974.

Proposed rebates will hit patients, not drug companies

Generics/General | Posted 27/11/2015

Attempts by US Congress to halt the rise in generics prices with new rebates payable by drugmakers has received a stinging rebuff from the Generic Pharmaceutical Association (GPhA).

Dr Reddy’s faces temporary sales ban on generic esomeprazole

Generics/News | Posted 27/11/2015

A US court has temporarily banned Dr Reddy’s Laboratories from selling its generic version of AstraZeneca’s heartburn drug Nexium (esomeprazole) in the US over allegations of trademark infringement.

Safety monitoring of drug interchangeability

Generics/Research | Posted 20/11/2015

When a brand-name drug is going off patent protection, pharmaceutical or generics companies may file an abbreviated new drug application (ANDA) for approval of a generic drug. As indicated by the US Food and Drug Administration (FDA), two drug products are claimed to be bioequivalent (BE) if the 90% confidence interval (CI) for the geometric mean ratio is totally within the bioequivalent limits of (80%, 125%) based on log-transformed data [1, 2] and an approved generic drug can be used as a substitute for the brand-name drug. FDA, however, does not indicate that approved generics of the same brand-name drug can be used interchangeably. Assume a patient switches the generic drug from BE 125% to BE 80% or from BE 80% to BE 125%, the change of the drug concentration in blood are both dramatic. As more generics become available in the marketplace, it is a concern whether the approved generics are safe and can be used interchangeably.

US politicians form Affordable Drug Pricing Task Force

Generics/General | Posted 20/11/2015

On 4 November 2015, democratic members of the House Committee on Oversight & Government Reform launched the Affordable Drug Pricing Task Force, which its members say will bring about ‘meaningful action to combat the skyrocketing costs of pharmaceuticals’.

FDA evaluation of residual solvents in generics

Generics/Research | Posted 13/11/2015

Differences between generics and their reference product in terms of inactive ingredients, e.g. residual solvents, are allowed if applicants provide information demonstrating that these differences do not affect the safety or efficacy of the proposed drug product. Authors from the Office of Generic Drugs at the US Food and Drug Administration (FDA) highlight general toxicology concerns caused by formulation differences between generic and originator drugs [1].

Tentative FDA approval for chemotherapy generic

Generics/News | Posted 13/11/2015

Aurobindo Pharma (Aurobindo) has received tentative US Food and Drug Administration (FDA) approval for chemotherapy generic palonosetron. The Indian generics maker received tentative FDA approval for its generic injectable intravenous palonosetron at a dosage of 0.25 mg/5 mL on 4 November 2015.

Prescribing generics for chronic musculoskeletal pain

Generics/Research | Posted 06/11/2015

The use of generics has become an issue of concern, both in public health and economical terms. Nevertheless, parallel to an ever-stronger advocacy for their use, various sources of information have reported patients’ concerns regarding substitution. Using a qualitative interview study, researchers from Geneva University Hospitals and the University of Geneva investigated the personal definitions and understanding of generics in patients suffering from non-specific chronic musculoskeletal pain, to elucidate the reasons that might explain why patients are confident or reluctant to take generics [1].

FDA making progress with ANDA backlog

Generics/General | Posted 06/11/2015

Despite an increase in the volume of abbreviated new drug application (ANDA) submissions, Type II API Drug Master Files (DMFs), supplements and amendments during financial year (FY)2014, the US Food and Drug Administration (FDA) has acted on more pending submissions compared to FY2013.

Sandoz launches authorized fluvastatin generic in US

Generics/News | Posted 06/11/2015

Sandoz, the generics division of Novartis, announced on 16 October 2015 the launch of an authorized generic version of Lescol (fluvastatin) tablets.

FDA evaluation of impurities in generics

Generics/Research | Posted 30/10/2015

Although generics may differ from their reference product in terms of inactive ingredients, which includes impurities, such compounds in generics, especially genotoxic impurities, are an area of increasing concern for the pharmaceutical and regulatory world. Authors from the Office of Generic Drugs at the US Food and Drug Administration (FDA) highlight general toxicology concerns caused by such formulation differences between generic and originator drugs [1].

Teva launches enlarged prostate generic in the US

Generics/News | Posted 30/10/2015

Generics giant Teva Pharmaceutical Industries (Teva) announced on 12 October 2015 the exclusive launch of generic dutasteride capsules (0.5 mg) in the US.

FDA evaluation of excipients in generics

Generics/Research | Posted 23/10/2015

Generics may differ from their reference product in terms of inactive ingredients, e.g. excipients, provided this does not affect the safety and efficacy of the product. Authors from the Office of Generic Drugs at the US Food and Drug Administration (FDA) highlight general toxicology concerns caused by such formulation differences between generic and originator drugs [1].

Brand-name drugmakers gain extra days of patent protection

Generics/General | Posted 23/10/2015

Brand-name drugmakers have gained some extra time, be it only days, for protection of their originator drugs after a ruling by the Court of Justice of the European Union clarified the date that drug patents expire.

ADHD generic receives US FDA approval

Generics/News | Posted 23/10/2015

US generics maker Impax Laboratories (Impax) announced on 21 October 2015 that the company had received approval for its attention deficit hyperactivity disorder (ADHD) guanfacine generic.

Effectiveness and cost-effectiveness of osteoporosis drugs

Generics/Research | Posted 16/10/2015

Comparison of treatments for osteoporosis has shown that pharmacological intervention for prevention of secondary fractures is cost-effective [1].

Sanofi launches authorized leflunomide generic in US

Generics/News | Posted 16/10/2015

Sanofi US announced on 1 October 2015 that the company’s US generics division, Winthrop, had launched an authorized generic version of Arava (leflunomide) tablets.

Impact of antiretroviral generics on the Italian National Health Service

Generics/Research | Posted 09/10/2015

The cost of antiretroviral therapies (ART) for the treatment of human immunodeficiency virus (HIV), which is now considered a chronic disease [1], represents an increasing burden for healthcare services worldwide. In particular, the availability on the market of new antiretroviral drugs, often more effective and more expensive than those available, lead to the need to identify cost containing strategies to ensure the economic sustainability of the healthcare service and to provide effective treatments to patients. Over the next few years, several patents for antiretroviral drugs will expire, giving the possibility for generics to enter the market. The availability of new generics on the market, may lead to a lowering of ART costs, and therefore to the affordability to provide the aforementioned new and innovative drugs.

FTC says formula tweaking may be anticompetitive

Generics/General | Posted 09/10/2015

The US Federal Trade Commission (FTC) has come down on the side of generics makers in a case about formula ‘tweaking’ by brand-name drugmakers.

Allergan makes deal with Amneal over its Namenda XR generic

Generics/News | Posted 09/10/2015

Allergan has gained some breathing space for the extended-release version of its blockbuster Alzheimer’s disease treatment Namenda XR (memantine XR) after making a deal to delay generics entry for more than four years.

Formulation differences between generics and reference products

Generics/Research | Posted 02/10/2015

Authors from the Office of Generic Drugs at the US Food and Drug Administration (FDA) highlight general toxicology concerns caused by formulation differences between generic and originator drugs [1].

FDA approval for guaifenesin generics

Generics/News | Posted 02/10/2015

Allergan (formerly Actavis) and its partner Perrigo Company (Perrigo) announced on 10 September 2015 that the companies had received US Food and Drug Administration (FDA) approval for their abbreviated new drug applications for three guaifenesin generics.

Stakeholder perceptions of generics

Generics/Research | Posted 25/09/2015

Considerable emphasis is presently being placed on usage of generics by governments focussed on the potential economic benefits associated with their use. Concurrently, there is increasing discussion in the lay media of perceived doubts regarding the quality and equivalence of generics. Consequently, the opinions of key stakeholders in the provision and consumption of medicines are of importance when considering how generics are accepted by both healthcare professionals and the general public alike.

First generic version of Alzheimer’s patch launched in US

Generics/News | Posted 25/09/2015

US generics company Alvogen announced on 31 August 2015 the launch of its generic equivalent of Novartis’s Alzheimer’s disease treatment Exelon patch (rivastigmine transdermal system) in the US.

The history of generics in France

Generics/Research | Posted 19/09/2015

The introduction of generics in France has been slow and cumbersome. It has taken 20 years for integration of generics into the market and for acceptance to be reached by healthcare professionals and patients. In a historical review of the emergence of generics in France, Rottembourg and Nasica-Labouze [1] reflect on developments in the generics market over this time.

Patient adherence and generics

Generics/Research | Posted 18/09/2015

Patient adherence to medication is a long-standing problem. Could lowering patient out-of-pocket costs through tier/copay reduction and generics substitution be a mean to improve adherence? This is a question Sanchez and co-authors tried to answer in their review of generics, cost and medication adherence [1].

Mylan sued over generic prostate cancer drug

Generics/News | Posted 18/09/2015

Generics giant Mylan announced on 18 August 2015 that the company was being sued by BTG International, Janssen Biotech, Janssen Oncology and Janssen Research & Development in connection with the filing of an abbreviated new drug application (ANDA) with the US Food and Drug Administration (FDA) for generic abiraterone acetate.

Observational study shows switching to generic olanzapine safe

Generics/Research | Posted 11/09/2015

A retrospective, observational study carried out by researchers from The University of Auckland, New Zealand (NZ) found no adverse health outcomes when patients switched between generic and brand-name olanzapine [1].

Yasmin generic launched in US

Generics/News | Posted 11/09/2015

US generics giant Mylan Pharmaceuticals (Mylan) announced on 8 September 2015 the US launch of its generic version of Bayer’s oral contraceptive pill Yasmin (drospirenone/ethinyl estradiol), following approval by the US Food and Drug Administration (FDA) of its abbreviated new drug applications (ANDA). This marks Mylan’s thirteenth oral contraceptive launch in the US.

Sun Pharma recalls drugs from troubled Halol plant

Generics/General | Posted 11/09/2015

India-based Sun Pharmaceutical Industries (Sun Pharma) is once again having to recall drugs from its troubled Halol plant in Gujarat, India.

Safety of generic immunosuppressants in solid organ transplantation

Generics/Research | Posted 04/09/2015

There are an increasing number of generic immunosuppressive drugs available for use in patients with solid organ transplant. However, given the potential for organ rejection with inadequate immunosuppression, there is considerable debate in the literature regarding the safety of generic immunosuppressive medications. To investigate these concerns, Amber Molnar and co-authors from the University of Ottawa, Canada, carried out a systematic review and meta-analysis comparing the clinical efficacy and bioequivalence of generic and originator immunosuppressive medications in the solid organ transplant population [1].

Generics applications under review by EMA – August 2015

Generics/General | Posted 04/09/2015

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].

US FDA approval for Hep B and osteoporosis generics

Generics/News | Posted 04/09/2015

Indian generics maker Aurobindo Pharma (Aurobindo) has received US Food and Drug Administration (FDA) approval for two more generics from its portfolio, bringing its total abbreviated new drug application (ANDA) approvals to 210 (182 final and 28 tentative).

Generic imatinib non-inferior to Gleevec

Generics/Research | Posted 28/08/2015

Following the approval of four generics of imatinib in Turkey, Demirkan and co-authors from the Dokuz Eylül University in Turkey compared the efficacy of these newly approved generics with the originator product Gleevec from Novartis [1].