Generics
Canada’s generics are too expensive
The same generics cost more in Canada than they do in similarly developed countries. In response to this, the premiers of each Canadian province recently agreed to lower the price of six expensive generics (amlodipine, atorvastatin, omeprazole, rabeprazole, ramipril and venlafaxine), setting reimbursement prices at 18% of the originator’s price. But this will still leave Canada out of line with other countries, including New Zealand, the UK and the US, say researchers at the University of Ottawa, Ontario, Canada.
EU Member States suspend generics approvals due to problems at CRO
The European Medicines Agency (EMA) announced on 5 December 2014 that some Member States have decided to suspend the marketing authorizations of medicines that have been authorized on the basis of studies conducted at India-based contract research organization (CRO) GVK Biosciences (GVK Bio) Hyderabad site.
First celecoxib generics hit US market
On 10 December 2014, generics makers Actavis, Mylan and Teva Pharmaceutical Industries (Teva) announced that they had all launched celecoxib generics in the US.
Irish pharmacists’ perceptions and attitudes towards generics
In June 2013, new legislation came into effect in Ireland - the Health (Pricing and Supply of Medical Goods) Act 2013 - that introduced generics substitution and reference pricing for the first time in this market [1]. As a result of this new legislation, Irish patients have a greater likelihood of receiving a generic medicine in place of a brand-name prescription medication. As healthcare professionals’ perceptions of generics are likely to have an impact on the successful implementation of the objectives of this legislation, the aim of this study was to assess pharmacists’ opinions of, and attitudes towards, generics in Ireland [2].
Generics losing out to brand-name drugs in Croatia
A combination of weak national guidelines and powerful marketing by the pharmaceutical industry has led to a rise in brand-name over generics prescriptions for psychopharmaceuticals in Croatia.
FDA withdraws automatic substitution of two methylphenidate generics
The US Food and Drug Administration (FDA) announced on 13 November 2014 that it had withdrawn the bioequivalence rating for two generic versions of Janssen Pharmaceutica’s attention deficit hyperactivity disorder drug Concerta (methylphenidate). The agency took the action due to concerns that the drugs may not be therapeutically equivalent to the brand-name drug.
Investigation into huge price increases for generics in the US
Two US Congressmen have sent letters to 14 drug manufacturers, including several major Indian firms, requesting information about the escalating prices they have been charging for generics.
Cipla petitions Indian Government to revoke Onbrez patents
India-based generics maker Cipla has asked the Indian Government to revoke five patents held by Swiss firm Novartis for its respiratory drug Onbrez (indacaterol), after launching its own generic version of the drug.
Canada partially lifts import ban on Indian manufacturing sites
In an attempt to avert drug shortages, Canada’s federal department responsible for health, Health Canada, has partially lifted an import ban on products from three Indian manufacturing facilities that were banned from importing generics into the country due to quality violations.
FDA revokes Ranbaxy’s esomeprazole and valganciclovir ANDAs
India-based generics maker Ranbaxy Laboratories (Ranbaxy) announced on 6 November 2014 that the company had been informed by the US Food and Drug Administration (FDA) of the agency’s decision to revoke its approval for the company’s generic versions of AstraZeneca blockbuster acid-reflux drug Nexium (esomeprazole) and F. Hoffman-La Roche’s cytomegalovirus treatment Valycte (valganciclovir).
