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FDA making progress but still needs to conduct more inspections

A report from the US Office of the Inspector General (OIG) published in May 2015 has found that although the US Food and Drug Administration (FDA) has made progress on the oversight and inspection of manufacturers of generics, it still needs to conduct outstanding pre-approval inspections of generics makers, which could lead to more timely approval of these drugs.

Generic opioid tops Medicare’s prescription chart

An analysis of Medicare’s prescription drug programme in the US has found that generics of the opioid painkiller Vicodin (hydrocodone/acetaminophen) was the most widely prescribed medicine to Medicare* beneficiaries in 2013. More than 691,000 providers prescribed the painkiller in 2013, including surgeons, dentists and pain experts, according to data released by the Centers for Medicare & Medicaid Services (CMS) on 30 April 2015.

Efforts to bring drug prices down in Ireland

Ireland’s Health Services Executive (HSE), which provides public health and social care services to everyone living in Ireland, reports that the average price of a pack of medicine provided to patients through their community drugs schemes in 2013 decreased to its lowest level in a decade.

Medicare data shows savings to be made with generics use

Despite generics accounting for far more claims in the US Medicare system than brand-name drugs, the total costs for each drug still came in much lower than costlier but much less used brand-name drugs.

Asian generics makers to focus on market expansion

According to a report by researchers at Frost & Sullivan (F&S) the Asian generics market will grow at a compound annual growth rate (CAGR) of 17–18% between 2014 and 2018 [1].

The cost of specialty pharmaceuticals

Specialty pharmaceuticals, which include difficult-to-manufacture small-molecule chemical drugs and biologicals, account for approximately 25% of total prescription costs, with expenditures on specialty prescriptions expected to quadruple by 2020 [1]. In fact, the absence of competition upon patent expiration has enabled the cost of biological drugs to increase seemingly without a ceiling.

Pharmacist survey highlights increasing generics costs

A survey of pharmacists has once again highlighted the increasing cost of generics in the US.

European countries should collaborate to reduce drug prices

According to a study published by the World Health Organization (WHO) on 26 March 2015 transparency and cooperation help to reduce high prices for new medicines.

Physicians’ views on biosimilars labelling

On 23 March 2015, the Alliance for Safe Biologic Medicines (ASBM), which represents patients and physicians, as well as originator biological and biosimilars companies in the US, released results of a survey, which showed that physicians ‘support transparent, clear labels with data that enables prescribers to learn about and evaluate the medicines available to their patients’ [1].

US biosimilars approvals expected to increase despite challenges

Biosimilar approvals in the US are expected to increase during the next five years, despite safety and regulatory challenges, according to a study from the Boston-based Tufts Center for the Study of Drug Development (CSDD).

Generics News Research General


Biosimilars News Research General