Generics
Dr Reddy’s could move manufacturing site with view to FDA approval
Generics manufacturer Dr Reddy’s Laboratories (Dr Reddy’s), determined not to lose out on US Food and Drug Administration (FDA) approval for its generic version of the acid-reflux blockbuster Nexium (esomeprazole), is considering switching manufacturing to a new facility.
Generics versus brand-name drugs
Is there a benefit to prescribing brand-name drugs versus prescribing generics? The answer appears to be no, according to evidence collected by researchers from the University of British Columbia in Vancouver and the University of Alberta in Edmonton, Canada [1].
Akorn submits ANDA for difluprednate ophthalmic emulsion
US generics maker Akorn has confirmed that it has filed an abbreviated new drug application (ANDA) with the US Food and Drug Administration (FDA) seeking approval to market difluprednate ophthalmic emulsion 0.05%.
Irish doctors’ attitudes towards generics
In June 2013, Ireland signed a new Act into law [the Health (Pricing and Supply of Medical Goods) Act 2013] paving the way for generics substitution and reference pricing for the first time in that market. As a consequence of the new legislation, Irish patients became more likely than ever to encounter generics.
FDA approves first generic esomeprazole
Esomeprazole is a proton pump inhibitor that reduces the amount of acid in the stomach. The drug is indicated to treat gastroesophageal reflux disease (GERD) in adults and children aged one year and older.
Generics applications under review by EMA – December 2014
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].
Prasco to market authorized colchicine generic in the US
US generics maker, Prasco Laboratories (Prasco), announced on 12 January 2015 that it had entered into an alliance with the US subsidiary of Japanese pharmaceutical company, Takeda, to distribute an authorized generic version of Colcrys (colchicine) in the US.
Patient perceptions of generics in Ireland
In an attempt to benefit from the cost savings associated with use of generics, in June 2013 the Irish Government introduced generics substitution and reference pricing for the first time via the Health (Pricing and Supply of Medical Goods) Act. However, as perceptions of Irish patients towards generics have not been published previously, the objective of this study was to assess how generics were perceived amongst patients in the Irish health system [1].
US judge invalidates 4 of 5 patents on Cubicin
A US federal judge has invalidated four out of the five patents on antibiotic Cubicin (daptomycin), paving the way for generics from June 2016.
GPhA comments on generics’ legislation and Trans-Pacific Partnership
Mr Ralph G Neas, President and CEO of the US Generic Pharmaceutical Association (GPhA), has commented on proposed legislation for generics in the US, as well as on provisions in the Trans-Pacific Partnership that he believes could impede access to medicines.
