Generics
Combating shortages and price increases in the US generics market
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
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
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
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
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
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
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
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
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
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].
