Generics

Pharmacists’ attitudes towards domestic generics in Afghanistan

Generics/Research | Posted 29/01/2016

The aim of the study by Hassali et al. was to survey community pharmacists regarding their attitudes about the quality and price of locally manufactured medicines [1].

FDA approval for generic antibiotic and arrhythmia drugs

Generics/News | Posted 29/01/2016

Indian generics maker Glenmark Pharmaceuticals (Glenmark) has gained approval for a generic antibiotic, linezolid, and tentative approval for its generic arrhythmia drug dronedarone.

Paediatric use of low-cost generic programs in the US

Generics/Research | Posted 22/01/2016

Low-cost generic drug programs (LCGPs) in the US increase the affordability of prescription medication that can treat many common paediatric conditions. LCGPs are a loss-leader pricing strategy used by eight of the top 10 pharmacy chains, e.g. Walmart, Walgreens, RiteAid, providing generics at co-payments of US$4‒5 for 30-day supplies or US$10‒12 for 90-day supplies. By using these programmes, no information is submitted through an individual’s prescription medication insurance benefit; thus, medication use data can be missing from administrative claims data. This phenomenon has implications for safety surveillance, quality measurement of health plans, and for researchers utilizing these data.

Roche and India's Glenmark reach truce over generic Tarceva

Generics/News | Posted 22/01/2016

The Swiss pharmaceutical company F. Hoffmann-La-Roche AG (Roche) has reached an out-of-court settlement with Indian generics company Glenmark Pharmaceuticals (Glenmark) over its patent for its lung cancer drug Tarceva (erlotinib hydrochloride).

Physicians’ and pharmacists’ perspectives on generics use

Generics/Research | Posted 15/01/2016

The review study of Toverud et al. shows that both physicians and pharmacists have acknowledged strategies for generics use as an attempt to curtail increasing drug expenditures [1]. However, in Northern Europe and in the US health professionals were confident about the generics available, whereas in countries with less mature healthcare systems there were concerns about the manufacturing sources of generics and the companies’ trustworthiness. A general marked variation was also found regarding control routines and bioequivalence requirements between countries with mature healthcare systems and those with developing ones.

Doctors in the US should remember to prescribe generics

Generics/Research | Posted 15/01/2016

According to the findings of a literature review carried out by the American College of Physicians (ACP) the major obstacle to increased use of generics in the US is patient and provider perceptions.

Use of generics in cardiovascular diseases

Generics/Research | Posted 08/01/2016

Researchers from Italy and the US carried out a meta-analysis with the aim of comparing the efficacy and adverse events, either serious or mild/moderate, of all generic versus brand-name cardiovascular medicines [1].

Cipla, Glenmark, Sun Pharma bidding for Teva–Allergan generics in the US

Generics/News | Posted 08/01/2016

Indian generics makers Cipla, Glenmark Pharmaceuticals (Glenmark) and Sun Pharmaceutical Industries (Sun Pharma) are reportedly bidding for a portfolio of US generics from Teva Pharmaceutical Industries (Teva).

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.