Generics
FDA sets up centre to improve quality of compounded drugs
The US Food and Drug Administration (FDA) has established a Center of Excellence to improve the quality of compounded drugs, which are created by combining two or more drugs and are not FDA-approved.
Medicare Part D has no impact on generics prescribing in long-term care
A recent observational study [1] in long-term care facilities in the US shows that the Medicare Part D programme has no significant effect on the rate of generic drug prescriptions, contrary to expectations.
FDA approves MS and prostate generics
The US Food and Drug Administration (FDA) in December 2019 approved the first generics of Gilenya (fingolimod) for multiple sclerosis (MS) and Rapaflo (silodosin) for benign prostatic hyperplasia.
American College of Physicians makes new recommendations to cut drug spending
A paper from the American College of Physicians (ACP) makes a number of policy recommendations to reduce costs of prescription drugs in the US, including annual caps for out-of-pocket spending and negotiating with manufacturers [1].
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].
Ontario proposes regulatory changes to simplify drug formulary listing and cut government payments to pharmacies
Following a number of changes in Canada’s generics and biosimilars landscape in 2019 [1-3], the Ontario Ministry of Health and Long-Term Care (the Ministry) is proposing a number of changes to streamline drug formulary listing and reduce the payments it makes to pharmacies for dispensing drug benefits.
WHO prequalifies antiparasitic API
The World Health Organization (WHO) has announced the prequalification of Pyrimethamine, manufactured by Macleods Pharmaceuticals Ltd, as an active pharmaceutical ingredient (API).
EMA recommends approval for two new generics
The European Medicines Agency’s (EMA) human medicines committee recommended seven new medicines for approval at its November 2019 meeting, including two generics: clopidogrel/acetylsalicylic acid and deferasirox.
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].
FDA identifies causes of drug shortages, recommends solutions
In response to growing concern over drug shortages, the US Food and Drug Administration (FDA) has released a report and accompanying statement regarding causes and solutions for the problem.
