Generics

Perceptions of the safety and side effects of generics

Generics/Research | Posted 06/05/2016

A quarter of doctors believe that generics are less safe and cause more side effects than brand-name drugs, according to a study carried out by researchers from New Zealand and the US [1].

FDA approves highest number of generics in 2015

Generics/General | Posted 06/05/2016

The US Food and Drug Administration (FDA) approved more than 700 generics in 2015, more than in any previous year, according to the annual report from the agency’s Office of Generic Drugs (OGD).

Perceptions of the effectiveness and quality of generics

Generics/Research | Posted 29/04/2016

More than a quarter of doctors and the general public believe that generics are less effective and of poorer quality than brand-name drugs, according to a study carried out by researchers from New Zealand and the US [1].

India’s bulk drug exports on the increase

Generics/General | Posted 29/04/2016

Driven by exports to both regulated and semi-regulated markets, India’s bulk drug exports are likely to grow at a compound annual growth rate (CAGR) of 12–14% up to 2018–2019, according to a recent study.

Generics perceptions in patients, pharmacists and doctors

Generics/Research | Posted 22/04/2016

A significant proportion of the general public, pharmacists and doctors have negative perceptions about generics, according to a study carried out by researchers from New Zealand and the US [1].

Sun Pharma to buy 14 drug brands from Novartis in Japan

Generics/News | Posted 22/04/2016

A wholly owned subsidiary of India’s Sun Pharmaceutical Industries (Sun Pharma) will acquire a portfolio of 14 established prescription brands from Novartis and Novartis Pharma in Japan for a sum of US$293 million. This will give Sun Pharma a strong foothold in Japan, the world’s second largest market after the US.

Substitution of generic antiepileptic drugs

Generics/Research | Posted 15/04/2016

Despite the availability of generic antiepileptic drugs (AEDs), patients and neurologists still hesitate to make a switch due to several reasons.

Apotex launches generic of nasal allergy treatment

Generics/News | Posted 15/04/2016

On 24 March 2016, Canada-based Apotex announced that it had launched mometasone furoate monohydrate nasal spray in the US, the first generic version of Merck’s Nasonex. Mometasone furoate monohydrate is a once-daily anti-allergen indicated for the treatment of nasal congestion for adults and children over two years.

Teva launches generic acamprosate in US

Generics/News | Posted 08/04/2016

Israeli generics giant Teva Pharmaceutical Industries (Teva) announced on 22 March 2016 that it had launched a generic version of alcohol dependence treatment Campral (acamprosate).

Impact of South Korea’s new drug–pricing policy on market competition

Generics/Research | Posted 01/04/2016

In April 2012, the Korean Government implemented a new policy to try and make its multiple sourced (off-patent) market more competitive. Their objective was to lower the price of generics through increased competition. The government in this way also aimed to reduce the costs for both patients [who have typically a 30% co-payment in ambulatory care (20% in hospitals)] and the National Health Insurance. The core of the policy was to establish the same maximum reimbursement price, i.e. the same ceiling price, for both the originator (brand-name) and the generic drug. This was expected to make the market more competitive, with generics manufacturers competing with each other to gain market share by lowering their prices. However, other professionals argued that this policy would still favour originators, given the general belief that an originator medicine, which is often from an international pharmaceutical company, would be better quality.

Costs and prices of entecavir to treat Hepatitis B

Generics/Research | Posted 25/03/2016

In an analysis of the costs and target prices of Hepatitis B treatment entecavir, author Andrew Hill from Liverpool University, UK and colleagues from Imperial College London, UK and Howard University, Washington DC, USA investigated how use of generics is affecting the cost of Hepatitis B treatment around the world [1].

FDA approves Teva’s Viagra generic

Generics/News | Posted 25/03/2016

Israeli generics giant Teva Pharmaceuticals (Teva) has received US Food and Drug Administration (FDA) approval for its generic version of Pfizer’s blockbuster erectile dysfunction drug Viagra (sildenafil), which is also called Revatio in the US.

Lupin and Gavis to divest generics to appease US FTC

Generics/General | Posted 25/03/2016

Lupin Pharmaceuticals (Lupin) and Gavis Pharmaceuticals (Gavis) have reportedly agreed to sell two generics in order to finalize Lupin’s acquisition of Gavis.

Is India ready to use only generics?

Generics/Research | Posted 18/03/2016

This editorial provides a balanced and neutral perspective of the debate regarding use of brand-name versus generic medicines, from an Indian endocrine point of view. It helps stakeholders arrive at appropriate decisions, using a process of informed and shared decision-making [1].

FDA lifts import ban on Chinese API to prevent shortages

Generics/General | Posted 18/03/2016

The US Food and Drug Administration (FDA) has lifted its ban on one of the active pharmaceutical ingredients (APIs) from China-based Zhejiang Hisun Pharmaceutical (Hisun) due to a ‘critical drug shortage concern’.

Hilary Clinton goes after Valeant for ‘predatory pricing’

Generics/General | Posted 11/03/2016

Presidential candidate Hilary Clinton has said in a new advertisement that she is ‘going after’ drugmaker Valeant Pharmaceuticals (Valeant) for its ‘predatory pricing’.

Perception and knowledge of generics in Portugal

Generics/Research | Posted 04/03/2016

Patients in Portugal are misinformed about generics, according to researchers from the Bragança Polytechnic Institute [1].

Biocon gets first European generics approval

Generics/News | Posted 04/03/2016

India-based biologicals specialist Biocon announced on 15 February 2016 that it had received its first European generics approval for a generic version of Astra Zeneca’s blockbuster anti-cholesterol drug Crestor (rosuvastatin).

Medicines Patent Pool signs first sub-licences for HCV med daclatasvir

Generics/General | Posted 04/03/2016

The Medicines Patent Pool (MPP) announced on 20 January 2016 the signing of its first sub-licences for generics of Bristol-Myers Squibb’s hepatitis C medicine Daklinza (daclatasvir).

Combating shortages and price increases in the US generics market

Generics/Research | Posted 26/02/2016

As a result of recent price increases and shortages, the US generics market has come under increasing scrutiny [1]. In a recent report by Wiske et al. authors from Brown, Duke and Harvard Universities discussed ways to increase the competitiveness of the US generics market that might address these problems [2].

Sun Pharma launches imatinib mesylate in the US

Generics/News | Posted 26/02/2016

On 1 February 2016, Sun Pharmaceutical Industries (Sun Pharma) launched imatinib mesylate in the US, a generic version of Gleevec (imatinib mesylate) developed by Novartis. Sun Pharma received final approval for imatinib mesylate from the US Food and Drug Administration (FDA) in December 2015, and was granted 180 days of marketing exclusivity from the time of its launch.

Measures to increase generics use in Greece

Generics/Research | Posted 19/02/2016

Austerity has forced Greece to introduce a number of measures to reduce the amount it spends on healthcare. But how have measures aimed at increasing generics use in the country been perceived by stakeholders? This was a question Karampali and co-authors from the National School of Public Health, Athens, Greece tried to answer [1].

European generics and biosimilars makers adopt disclosure rules

Generics/General | Posted 19/02/2016

The European Generic and Biosimilar Medicines Association (EGA) has published disclosure rules for the generic, biosimilar and value added medicines industry. This builds on the EGA Code of Conduct adopted in 2015.

UK paves way for generics of Eli Lilly’s Alimta

Generics/News | Posted 19/02/2016

The UK High Court ruled on 12 February 2016 that Eli Lilly’s vitamin regimen patent for its lung cancer blockbuster Alimta (pemetrexed disodium) is not infringed by a generic version of the drug sold by Allergan’s Actavis unit.

Consumer choice between generic and brand-name medicines in a small generics market

Generics/Research | Posted 12/02/2016

Background
Generics offer an opportunity to governments to contain pharmaceutical expenditures, as they are generally 10‒80% lower in price than the originator brand-name medicines. Belgium has a small generics market, which takes up 15% of the total pharmaceutical market (in packages sold).

Mylan launches generic seizure drug in US

Generics/News | Posted 12/02/2016

US generics manufacturer Mylan announced on 19 January 2016 that it had launched a generic version of Meda Pharms’ Felbatol (felbamate) tablets in dosages of 400 and 600 mg in the US.

Generics applications under review by EMA – December 2015

Generics/General | Posted 05/02/2016

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].

Celgene settles Revlimid patent litigation with Natco Pharma

Generics/News | Posted 05/02/2016

Celgene Corporation (Celgene) is to provide India-based Natco Pharma and its US partner, Arrow International – a unit of Allergan – the license to manufacture and market generic Revlimid (lenalidomide) in the US from 31 January 2026, following expiration of patents in the US in April 2017. This will expedite generics competition for the drug, which currently makes up 60% of Celgene’s annual revenue.

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.