Generics

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.