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FDA evaluation of impurities in generics

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].

FDA evaluation of excipients in generics

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].

Effectiveness and cost-effectiveness of osteoporosis drugs

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

Impact of antiretroviral generics on the Italian National Health Service

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.

Formulation differences between generics and reference products

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].

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.

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].

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].

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].