Generics
FDA approval for guaifenesin generics
Allergan (formerly Actavis) and its partner Perrigo Company (Perrigo) announced on 10 September 2015 that the companies had received US Food and Drug Administration (FDA) approval for their abbreviated new drug applications for three guaifenesin generics.
Stakeholder perceptions of generics
Considerable emphasis is presently being placed on usage of generics by governments focussed on the potential economic benefits associated with their use. Concurrently, there is increasing discussion in the lay media of perceived doubts regarding the quality and equivalence of generics. Consequently, the opinions of key stakeholders in the provision and consumption of medicines are of importance when considering how generics are accepted by both healthcare professionals and the general public alike.
First generic version of Alzheimer’s patch launched in US
US generics company Alvogen announced on 31 August 2015 the launch of its generic equivalent of Novartis’s Alzheimer’s disease treatment Exelon patch (rivastigmine transdermal system) in the US.
The history of generics in France
The introduction of generics in France has been slow and cumbersome. It has taken 20 years for integration of generics into the market and for acceptance to be reached by healthcare professionals and patients. In a historical review of the emergence of generics in France, Rottembourg and Nasica-Labouze [1] reflect on developments in the generics market over this time.
Patient adherence and generics
Patient adherence to medication is a long-standing problem. Could lowering patient out-of-pocket costs through tier/copay reduction and generics substitution be a mean to improve adherence? This is a question Sanchez and co-authors tried to answer in their review of generics, cost and medication adherence [1].
Mylan sued over generic prostate cancer drug
Generics giant Mylan announced on 18 August 2015 that the company was being sued by BTG International, Janssen Biotech, Janssen Oncology and Janssen Research & Development in connection with the filing of an abbreviated new drug application (ANDA) with the US Food and Drug Administration (FDA) for generic abiraterone acetate.
Observational study shows switching to generic olanzapine safe
A retrospective, observational study carried out by researchers from The University of Auckland, New Zealand (NZ) found no adverse health outcomes when patients switched between generic and brand-name olanzapine [1].
Yasmin generic launched in US
US generics giant Mylan Pharmaceuticals (Mylan) announced on 8 September 2015 the US launch of its generic version of Bayer’s oral contraceptive pill Yasmin (drospirenone/ethinyl estradiol), following approval by the US Food and Drug Administration (FDA) of its abbreviated new drug applications (ANDA). This marks Mylan’s thirteenth oral contraceptive launch in the US.
Sun Pharma recalls drugs from troubled Halol plant
India-based Sun Pharmaceutical Industries (Sun Pharma) is once again having to recall drugs from its troubled Halol plant in Gujarat, India.
Safety of generic immunosuppressants in solid organ transplantation
There are an increasing number of generic immunosuppressive drugs available for use in patients with solid organ transplant. However, given the potential for organ rejection with inadequate immunosuppression, there is considerable debate in the literature regarding the safety of generic immunosuppressive medications. To investigate these concerns, Amber Molnar and co-authors from the University of Ottawa, Canada, carried out a systematic review and meta-analysis comparing the clinical efficacy and bioequivalence of generic and originator immunosuppressive medications in the solid organ transplant population [1].
