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Research

Market evolution of new drug formulations

Brand-name drug manufacturers sometimes create modified versions of their approved drugs which can include new strengths, dosage forms, or delivery routes. This product modification can meaningfully increase patient treatment options; however, some cases have come under scrutiny as they do not offer any clear therapeutic advantages. This second practice is a form of ‘product hopping’, a method used by manufacturers to prolong revenue streams related to market exclusivity. Complementary strategies such as product discontinuation can augment the impact of product hopping.

Factors associated with increased side effects and lower perceived efficacy when switching to a generic

In 2017, the New Zealand Pharmaceutical Management Agency (PHARMAC) changed the funded version of the antidepressant venlafaxine from Efexor XR (the branded originator) or Arrow-Venlafaxine XR (a generic version) to a new generic, Enlafax XR. MacKrill and Petrie examined differences in preferences and perceptions between patients switched from the originator branded venlafaxine to the new generic, and those switched from the old generic version [1]. Specifically, they investigated the factors associated with preference for branded medicines, side effects reported following switching and efficacy ratings of the new generic.

Escalating prices of generic drugs in the US

Generic prescription drug prices have been escalating rapidly in the US. In 2014, generic drug prices increased by 38% on average. Public outcry has led to a flurry of legislative proposals, and two federal bills were introduced in 2017 to improve price transparency and identify drugs exhibiting outlier ‘price spikes’, however, both remain unenacted. In the first three months of 2018, 53 drug pricing transparency bills were initiated in 23 state legislatures.

The 700-dollar vitamin: excessive generics prices in the US

Authors from Johns Hopkins University School of Medicine discuss excessive prices for generics in the US, using vitamin K1 as an example [1].

European regulatory framework for approval of biosimilars – perspectives and future developments

Regulatory agencies around the world have reviewed and approved marketing authorization applications for biosimilars via specific marketing authorization procedures that vary between jurisdictions. In Europe, the European Medicines Agency (EMA) has already more than 10 years of experience with review of applications and approval of biosimilars for use in the European Union.

Safety surveillance of bevacizumab biosimilar (Bevax) in Argentina

Benefit-risk evaluations are mandatory throughout the life cycle of a therapeutic agent, to guarantee efficacy for the authorized indications without an unacceptable incidence of adverse effects. This monitoring can be carried out using pharmacovigilance (PhV) procedures, which are vital in the identification and prevention of adverse drug reactions (ADRs). Due to the inherent variability of bioproduction, this is of paramount importance for biological products, including biosimilars.

Impact of generic reference pricing on candesartan and rosuvastatin use in South Africa

Researchers from South Africa and The Netherlands investigated the effect that generics and generic reference pricing has on candesartan and rosuvastatin use in South Africa [1].

Safety of brand-name and generic angiotensin II receptor blockers

Authors of a study carried out in Canada found that there is still uncertainty regarding generics substitution of angiotensin II receptor blockers (ARBs) [1].

Effectiveness of chronic hepatitis C treatment using direct-acting antivirals: real-life data

Hepatitis is an inflammation of the liver and can be caused by medications, toxins, severe alcohol use and other medical conditions. Hepatitis can also be caused by viruses, most commonly hepatitis A, B and C. Both hepatitis A and B can be dangerous, but there are effective vaccines against both viruses, however, there is no vaccines for hepatitis C [1].

Higher generics use results in higher Medicare Part D star ratings

A study conducted by researchers from Auburn University and IMPAQ International has found that Medicare# Part D* prescription plans with higher generics use have higher summary star ratings and improved member experience [1].