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Addressing patient misconceptions about generics

In the face of increasing drug costs, substitution by generics is often used as a strategy by healthcare systems to rein in expenditure. However, patient misconceptions about generics can hinder such substitutions. Researchers Sanchez and Zurek discuss how pharmacists can improve this situation by educating patients on the use and safety of generics [1].

Policies to address price rises in old generics

Old, off-patent drugs are becoming increasingly expensive. But how can policymakers address the problem? Naren P Tallapragada from the Harvard Medical School discusses the underlying causes of the high-cost off-patent drug problem and proposes some policy solutions that could address the problem [1].

Therapeutic substitution could save Americans US$73 billion

Therapeutic substitution could save the America healthcare system US$73 billion and patients US$24.6 billion in out-of-pocket expenses, according to US researchers [1].

Transparency in the Australian pharmaceutical industry

In Australia, the promotion of medicines to healthcare professionals is controlled by self-regulatory schemes operated by the pharmaceutical industry.

Factors affecting generics entry

Edward Kong, Research Assistant at the Yale University, Department of Economics, carried out a study into the factors that influence a generics maker’s decision to enter a specific market [1].

Competition in the generics industry

In theory, an increase in the use of generics should help to reduce overall drug expenditures. However, growth in spending on medicines in the US increased by US$46.2 billion, or 12.2%, over 2014 levels, reaching US$425 billion in 2015 [1]. This increase comes despite a simultaneous growth in spending on generics, which increased by US$7.9 billion (7.4%) to US$114.1 billion in 2015.

Generic antibiotics could be contributing to bacterial resistance

Therapeutic non-equivalence of generic antibiotics could be contributing to the global problem of bacterial resistance, according to researchers from the Universidad de Antioquia in Colombia.

Different approaches to bioequivalence trials for EMA evaluation

Selection of robust bioequivalence study designs is a difficult task for manufacturers of generics. Author Nathaniel Refalo from the Malta Medicines Authority and colleagues therefore investigated whether different approaches in various products assessed by the European Medicines Agency (EMA) during the approval phase resulted in a reduction in the resources required to show bioequivalence [1].

South Africa’s expedited registration policy not speeding up access to biosimilars

Since South Africa’s National Department of Health (DoH) implemented a fast-track registration policy in 2003 the large number of generics applications has led to a backlog in approvals [1]. This has led to concern that this backlog is having a detrimental effect on patient access to critical pharmaceutical medicines and in particular biosimilars [2].

South Africa’s expedited registration policy for rapid access to critical medicines under threat by generics

In 2003, the National Department of Health (DoH) of South Africa implemented a fast-track registration policy, not only for new chemical entities (NCEs) considered essential for national health and which may not be on the Essential Medicines List (EML) of South Africa, but also for all medicines on the EML, the majority of which are generics [1].

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