Generics/Research
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.
The role of authorized generics in improving access to medicines
In recent years, many authorized generic drug products have been launched by pharmaceutical companies at lower prices than their brand-name originators. A recent viewpoint, published in JAMA Internal Medicine [1], discusses the ways that authorized generics are launched in the US. It also considers whether these products improve lower costs and access to medicines.
Approving generics of polymer-based parenteral long-acting drugs
To assure the safety and the efficacy of drugs, quality and batch-to-batch reproducibility need to be guaranteed. In the case of parenteral long-acting products, the regulatory authorities in the European Union (EU) and the US deviate in their guidance, differences include how to define such products and in vitro release assays.
Adherence improves long-term prognosis and medical costs in Japan
Medical costs and the burden associated with cardiovascular disease are on the rise. In Japan, due to changes in lifestyle and other factors, the number of inpatients with cardiovascular disease and other conditions is increasing at a rate of 10,000 per year.
Anti-competitive strategic patenting by pharmaceutical companies
Drug prices have considerably increased in recent years, affecting healthcare budgets and posing a serious risk to the affordability and accessibility of medicines for society [1]. Various reasons for high drug prices are put forward by pharmaceutical companies, including the complexity of drug discovery and development, as well as the expensive and lengthy regulatory procedures involved [2]. While these reasons may play an important role in this regard, some practices by pharmaceutical companies substantially contribute to this problem.
Perspectives of prescribing practices in public health facilities in Eswatini
Rational medicines use (RMU) is the prescribing/dispensing of good quality medicines to meet individual patient’s clinical needs. Policymakers, managers and frontline providers play critical roles in safeguarding medicine usage thus ensuring their rational use. Therefore, in order to investigate this, researchers carried out a study investigating the perspectives of key health system actors on prescribing practices and factors influencing these in Eswatini [1]. Public sector healthcare service delivery in the region is carried out through health facilities (public sector, not-for-profit faith-based, industrial) and community-based care.
Familiarity with substitution of prescription generics increases positive attitudes toward OTC generics
Introduction of measures to stimulate increased sale of generics swept over the Nordic countries in the 2000s. In Sweden, in 2002, generics substitution for reimbursed prescription drugs was made mandatory and the switching rates rose over the years to reach almost 100%. Although generics policies seem to be reserved for the prescription drug market [1], a contagion effect has been observed in the market for over-the-counter (OTC) drugs. Soon after the Swedish state monopoly on the sale of pharmaceutical products was terminated and new measures to boost sales of generic prescriptions was put in place in 2009, new generic brands of the top-selling OTC analgesics emerged on the market, all with a lower price compared with previously established brands [2]. Since OTC drugs are usually excluded from pharmaceutical benefit schemes, it is reasonable to expect a demand for cheaper brands when such options exist. Albeit, time has shown that the original brands often hold their position as OTC market leaders.
Cost savings after switching to generic tacrolimus
The use of narrow therapeutic index generic immunosuppressant in solid organ transplantation is controversial. This is because drugs with a narrow therapeutic index, such as immunosupressants, are defined by a narrow distance between the dosage that induces a desired effect and that dosage which already has a toxic effect [1]. This has led to medical and scientific societies being reluctant to switch to generics of these types of drugs because they think that small pharmacokinetic differences could predispose episodes of acute rejection or of adverse effects derived from toxicities of the product [2, 3].
