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The impact of generics regulation in Brazil

Sales of originator drugs have decreased and the number of generics manufacturers have increased following the introduction of the Brazilian Generics Law, reports a new study [1].

FDA generics approvals increasing but not for at-risk generics

Analysis of generics approvals by the US Food and Drug Administration (FDA) reveals a slight increase in the total number of applications approved between 2016 and 2018. Over 1,800 applications were approved in this time, however, there was no significant change to the proportion of these drugs in shortage or with limited competition [1].

Safety of generics in US questioned

US Food and Drug Administration (FDA) regulations guarantee a safe drug supply. However, author Michael White, from the Health Outcomes, Policy, and Evidence Synthesis Group, University of Connecticut School of Pharmacy, Connecticut, USA, questions the safety of foreign generic drug imports [1].

Generics transition brings economic benefits to Canada

Economic analysis of genericization of cancer medicines in Canada has confirmed their cost-effectiveness. This rare example of an economic evaluation of the benefits of generics was published in Current Oncology [1].

A call for economic reassessment of drug regimens

Canadian researchers have called for the cost-effectiveness of drug products to be routinely reassessed. Their study, published in Current Oncology [1], has shown that cost-effectiveness of products alters significantly after generics are introduced. This has big implications for healthcare budgets and access to medicines, in Canada and worldwide.

Pharmacy chain drives choice among US generics manufacturers

A recent study shows that the dispensing pharmacy chain is a strong driver of generics manufacturer choice in the US, which could have implications for economic models of the generic drugmarket [1].

First pregabalin generics approved by FDA

In July 2019, the US Food and Drug Administration (FDA) approved multiple applications for the first generics of Lyrica (pregabalin) for the management of fibromyalgia, postherpetic neuralgia, neuropathic pain associated with diabetic peripheral neuropathy or spinal cord injury, and as adjunct therapy for partial-onset seizures in patients aged 17 years or over.

Strong generics nocebo effect found in US

In the US, generic drug products account for approximately 90% of all prescriptions dispensed [1]. Despite this, there is a continued lack of trust in these drug products. Generics are often perceived as less effective and less safe than their brand-name reference products. Now, researchers at Brigham and Women’s Hospital and Harvard Medical School have confirmed that in the US, generics exhibit a strong nocebo effect. Here, negative bias against generics leads to negative clinical outcomes [2]. The researchers call for more education about generics to increase awareness of their benefits and increase access to these lower-priced medicines.

New evidence: comparable clinical outcomes for generic and brand medications

New research carried out at Brigham and Women’s Hospital and Harvard Medical School, provides additional evidence that shows generic and brand-name drugs have comparable clinical outcomes [1].

Evaluating success: generics substitution policy in Chile

The effectiveness of Chile’s 2014 generics substitution policy has been assessed by an international team of researchers. In their BMJ Global Health [1] article, the authors reveal that, although there has been a decrease in the uptake of expensive originator drugs, this is not mirrored by an increase in the uptake of less expensive bioequivalent products. This shows that further work is needed to help increase the uptake of generics in Chile.