Generics
Teva launches generic testosterone gel and overactive bladder treatment in the US
In April 2019, Israeli generics giant Teva Pharmaceutical Industries (Teva) announced the launch of generic versions of AndroGel (testosterone gel) 1.62% CIII and VESIcare (solifenacin succinate) tablets, 5 mg and 10 mg, in the US.
Adherence to generic versus brand-name statins and associated clinical and economic outcomes
Despite evidence supporting the efficacy of statins for the treatment and prevention of cardiovascular disease, a lack of adherence to statin treatment continues to be a major problem. Sicras-Mainar and colleagues investigated real-world treatment persistence and medical possession for generic versus brand-name statins used in routine clinical practice, and assessed associated clinical and economic outcomes [1].
Multi-state lawsuit alleges widespread generic price fixing in the US
A sweeping lawsuit filed on 10 May 2019 by over 40 US states alleges that a number of major drug companies conspired to inflate the prices of generic drugs by as much as 1,000%.
EMA approves hypertension and Parkinson’s generics
The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) announced on 26 April 2019 that it had recommended granting marketing authorization for hypertension and Parkinson’s generics.
Mixed beliefs about generics among patients in a Malaysian hospital
The Malaysian Government is heavily subsidizing public healthcare expenditure in order to provide access to health care for all citizens. In 2017, total healthcare expenditure in the country was approximately 9.4% of the annual budget. In order to overcome the increasing cost of health care, the government has implemented a National Generic Medicine Policy in 2006 to promote healthier competition in medicine pricing and to make medicines more affordable to the general public. After 10 years of policy implementation, authors from the Ministry of Health Malaysia assess patients' beliefs about generics.
US Court rejects Teva’s lawsuit over generic Restasis
The US District Court for the District of Columbia has discarded lawsuits from generics giant Teva Pharmaceutical Industries (Teva) regarding its first-to-file exclusivity rights on a generic version of the blockbuster dry eye drug Restasis (cyclosporine).
Stada launches generic Exforge following patent revocation
German generics producer Stada Arzneimittel announced on 20 March 2019 that it is set to launch a generic version of the antihypertensive Exforge (amlodipine/valsartan combination), following the revocation of a Novartis European patent.
FDA releases statement on generic drug quality
A statement released by the US Food and Drug Administration (FDA) responds to recent press reports of quality issues and outlines the Agency’s ongoing efforts to maintain the quality of generic drugs manufactured both in the US and overseas.
Spotlight on the role of pharmacy benefit managers in the fight against rising drug prices
High prices of prescriptions have become a major issue for patients and politicians in the US. In addition to scrutiny of pharmaceutical companies, the role of distributors, insurance companies and middlemen including pharmacy benefit managers (PBMs) is now attracting attention.
Market evolution of new drug formulations
Brand-name drug manufacturers sometimes create modified versions of their approved drugs which can include new strengths, dosage forms, or delivery routes. This product modification can meaningfully increase patient treatment options; however, some cases have come under scrutiny as they do not offer any clear therapeutic advantages. This second practice is a form of ‘product hopping’, a method used by manufacturers to prolong revenue streams related to market exclusivity. Complementary strategies such as product discontinuation can augment the impact of product hopping.
