Generics

FDA evaluation of impurities in generics

Generics/Research | Posted 30/10/2015

Although generics may differ from their reference product in terms of inactive ingredients, which includes impurities, such compounds in generics, especially genotoxic impurities, are an area of increasing concern for the pharmaceutical and regulatory world. Authors from the Office of Generic Drugs at the US Food and Drug Administration (FDA) highlight general toxicology concerns caused by such formulation differences between generic and originator drugs [1].

Teva launches enlarged prostate generic in the US

Generics/News | Posted 30/10/2015

Generics giant Teva Pharmaceutical Industries (Teva) announced on 12 October 2015 the exclusive launch of generic dutasteride capsules (0.5 mg) in the US.

FDA evaluation of excipients in generics

Generics/Research | Posted 23/10/2015

Generics may differ from their reference product in terms of inactive ingredients, e.g. excipients, provided this does not affect the safety and efficacy of the product. Authors from the Office of Generic Drugs at the US Food and Drug Administration (FDA) highlight general toxicology concerns caused by such formulation differences between generic and originator drugs [1].

Brand-name drugmakers gain extra days of patent protection

Generics/General | Posted 23/10/2015

Brand-name drugmakers have gained some extra time, be it only days, for protection of their originator drugs after a ruling by the Court of Justice of the European Union clarified the date that drug patents expire.

ADHD generic receives US FDA approval

Generics/News | Posted 23/10/2015

US generics maker Impax Laboratories (Impax) announced on 21 October 2015 that the company had received approval for its attention deficit hyperactivity disorder (ADHD) guanfacine generic.

Effectiveness and cost-effectiveness of osteoporosis drugs

Generics/Research | Posted 16/10/2015

Comparison of treatments for osteoporosis has shown that pharmacological intervention for prevention of secondary fractures is cost-effective [1].

Sanofi launches authorized leflunomide generic in US

Generics/News | Posted 16/10/2015

Sanofi US announced on 1 October 2015 that the company’s US generics division, Winthrop, had launched an authorized generic version of Arava (leflunomide) tablets.

Impact of antiretroviral generics on the Italian National Health Service

Generics/Research | Posted 09/10/2015

The cost of antiretroviral therapies (ART) for the treatment of human immunodeficiency virus (HIV), which is now considered a chronic disease [1], represents an increasing burden for healthcare services worldwide. In particular, the availability on the market of new antiretroviral drugs, often more effective and more expensive than those available, lead to the need to identify cost containing strategies to ensure the economic sustainability of the healthcare service and to provide effective treatments to patients. Over the next few years, several patents for antiretroviral drugs will expire, giving the possibility for generics to enter the market. The availability of new generics on the market, may lead to a lowering of ART costs, and therefore to the affordability to provide the aforementioned new and innovative drugs.

FTC says formula tweaking may be anticompetitive

Generics/General | Posted 09/10/2015

The US Federal Trade Commission (FTC) has come down on the side of generics makers in a case about formula ‘tweaking’ by brand-name drugmakers.

Allergan makes deal with Amneal over its Namenda XR generic

Generics/News | Posted 09/10/2015

Allergan has gained some breathing space for the extended-release version of its blockbuster Alzheimer’s disease treatment Namenda XR (memantine XR) after making a deal to delay generics entry for more than four years.

Formulation differences between generics and reference products

Generics/Research | Posted 02/10/2015

Authors from the Office of Generic Drugs at the US Food and Drug Administration (FDA) highlight general toxicology concerns caused by formulation differences between generic and originator drugs [1].

FDA approval for guaifenesin generics

Generics/News | Posted 02/10/2015

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

Generics/Research | Posted 25/09/2015

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

Generics/News | Posted 25/09/2015

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

Generics/Research | Posted 19/09/2015

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

Generics/Research | Posted 18/09/2015

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/News | Posted 18/09/2015

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

Generics/Research | Posted 11/09/2015

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

Generics/News | Posted 11/09/2015

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

Generics/General | Posted 11/09/2015

India-based Sun Pharmaceutical Industries (Sun Pharma) is once again having to recall drugs from its troubled Halol plant in Gujarat, India.