Generics
Effect of co-insurance and reference pricing on generics entry
To study the impact of reference pricing on generics entry Brekke and co-authors developed a novel Salop-type model where a brand-name producer competes with several generics makers in terms of prices [1].
Indian pharma industry to get government support
In a bid to promote the manufacture of pharmaceuticals in the country, the Indian Government has announced plans to set up a Rs 500-crore venture capital fund to provide cheaper loans to firms looking to establish or upgrade manufacturing facilities.
Mylan launches generic asthma inhaler in UK
US generics manufacturer Mylan announced on 8 June 2015 that it had launched the first bioequivalent alternative to GlaxoSmithKline (GSK)’s asthma inhaler Seretide/Advair (fluticasone/salmeterol) in the UK.
Effect of reference pricing on generics entry
Reference pricing can produce substantial savings, but what conditions are the most likely to result in cost savings? This was a question addressed by Brekke and co-authors from the University of Minho in Portugal in their Working Paper [1].
Generics of ADHD drug launched in US
Shire Pharmaceutical’s (Shire’s) blockbuster attention deficit hyperactivity disorder (ADHD) drug Intuniv is now facing competition as four generics of the therapy have been launched on the US market.
Malaysian physicians have negative perceptions of generics
A study investigating the knowledge, perceptions and behaviour of physicians from private medical centres in Malaysia regarding generics found that the majority of physicians had negative perceptions about the safety, quality and efficacy of generics [1].
Osteoporosis and ADHD generics launched in USA
On 1 and 2 June 2015, Israeli generics giant Teva Pharmaceutical Industries (Teva), launched its latest osteoporosis and ADHD generics, respectively.
Drug evergreening strategies in India
A study of drug patent evergreening in India found that this is a strategy that has been used by manufacturers of a particular drug to restrict or prevent competition from manufacturers of generic equivalents. It is also a strategy still being used in India despite the efforts of Section 3(d) of the Indian Patent Act to curb such practices [1].
Generics applications under review by EMA – April 2015
Generic medicines in Europe can be approved either centrally via the European Medicines Agency (EMA) or nationally via the local regulatory body [1]. Approval by EMA takes place by using a centralized procedure. This leads to approval of the product in all 28 European Union (EU) Member States and in Iceland, Liechtenstein and Norway. At a country level, if approval in a single EU Member State only is required, this can take place using the national procedure. However, as soon as a company seeks approval in two or more Member States, a decentralized procedure or mutual recognition procedure must be used [2].
FDA receives application for first generic of HIV drug dolutegravir
India-based Aurobindo Pharma (Aurobindo) has submitted an abbreviated new drug application (ANDA) for HIV treatment dolutegravir for tentative approval, to the US Food and Drug Administration (FDA).
