Generics/Research
Laws on packaging, substitution and prescription of generics in Brazil
According to the National Health Surveillance Agency (Agencia Nacional de Vigilancia Sanitaria, ANVISA), the approval of medicines aims to improve the Brazilian population's access to better, safe and quality medicines at lower prices.
Legal requirements on equivalence studies for generics in Brazil
The creation of the legal system for generic medicines began with the introduction of Law Number 9787 in February 1999 (Brazil 1999). According to the National Health Surveillance Agency (Agencia Nacional de Vigilancia Sanitaria, ANVISA), the approval of medicines aims to improve the Brazilian population's access to better, safe and quality medicines at lower prices.
Backlog of drug patents in Brazil
In an article on ‘How much does the backlog on drug patents cost for health in Brazil?’, Jannuzzi et al. in 2017 [1] showed backlogs in the analysis of patent applications in Brazil. These delays, known as ‘backlogs‘, extend the term of patents granted on medicines and delay the entry of generics into the market.
Technological approaches to drug repurposing for cancer treatment
Cancer is one of the leading causes of death in the world today, causing nearly 10 million deaths in 2018 alone. Despite extensive research into new treatments, when these eventually reach the market, they are often very expensive. The strategy of drug repurposing is being applied to identify already approved drug products as potential cancer therapies. This can bring new cancer treatments to patients faster and at a lower price. A review, published in Signal Transduction and Targeted Therapy [1], summarizes approaches used for drug repurposing and discusses the main barriers to uptake.
Non-profit generics manufacturers in the US reduce foreign dependence
Non-profit generics drug manufacturers have the potential to make important contributions to reduce foreign dependence on generic drugs in the US, argues an article published in The Journal of Law Medicine and Ethics [1].
More out-of-pocket costs for US patients with rising prescription drug prices
Increasing prices of brand-name drugs in the US, leaves patients with increasing costs at the pharmacy, says a study published in JAMA Network Open [1].
Difficult-to-make drugs meet US quality standards
Difficult-to-make prescription pharmaceuticals marketed in the US consistently meet quality standards even when manufactured outside the country, finds a study published in JAMA Network Open [1].
New in vitro–in vivo simulations predict generic bioequivalence
If we can predict the outcome of bioequivalence studies in the generic drug development process, we can save time and money. Now, a new in vitro–in vivo simulation (IVIVS) approach to predict the in vivo outcome of these studies, published in Materials [1], has been developed by researchers National and Kapodistrian University of Athens.
Dispensing branded drugs costs Medicare over a billion dollars
Branded drugs dispensed instead of generics at the request of physicians and patients have incurred annual costs of over US$1 billion to the Medicare programme. and US$270 million to patients, reveals a study published in JAMA Network Open [1].
Debate about generic versus brand-name drugs for glaucoma
Glaucoma is a chronic, largely asymptomatic disease that often needs lifelong treatment. The choice of drugs is extremely important as the cost of drugs; side effects and efficacy often affect compliance and adherence to therapy. For a given class of drug, there are three options including brand-name drugs, generics and branded generics. Brand-name drugs are costlier compared to generics and branded generics because they are originator molecules developed by a company after many years of research and come into the market with a patent. Whereas branded generics are produced by a different company once the patent of the originator company expires. Moreover, competition amongst different companies to make the similar formulation of branded generics further reduces the cost.
