Generics
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].
Glenmark and Lupin gain FDA approval for nervous system agents
Indian generics maker Glenmark Pharmaceuticals has been granted tentative US Food and Drug Administration (FDA) approval for its multiple sclerosis (MS) generic, while generics giant Lupin Ltd has also received FDA approval for its Dilantin generic, an anti-seizure medication.
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].
UK Labour Party proposes state run generics manufacturer
In a speech at the 2019 Labour Party Conference, leader Jeremy Corbyn introduced the ‘Medicines For The Many’ initiative, which aims to put ‘public health before private profit’ and includes plans to establish a state-owned pharmaceutical company to manufacture generic medicines in the UK.
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.
Ranitidine recalls escalate as FDA declares ‘unacceptable’ levels of NDMA in the drug
On 2 October 2019, the US Food and Drug Administration (FDA) declared that it had found ‘unacceptable’ levels of the probable human carcinogen N-nitrosodimethylamine (NDMA) in the heartburn drug Zantac (ranitidine) and its generic versions.
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.
Alimta and Orfadin generics approved by FDA
The US Food and Drug Administration (FDA) has tentatively approved Mylan’s pemetrexed, a generic version of Eli Lilly’s cancer drug Alimta, and approved Novitium Pharma’s generic equivalent of Swedish Orphan Biovitrum's Orfadin (nitisinone capsules).
