Generics
The cost of evergreening strategies
The practice of evergreening, where pharmaceutical companies make small patentable changes to existing products with soon-to-expire patents, contributed to increased healthcare costs in Switzerland, according to a study by authors from the University of Geneva and Geneva University Hospitals [1].
Perrigo receives tentative FDA approval for generic Prandin
US-based drugmaker Perrigo Company (Perrigo) announced on 19 July 2013 that it had received tentative approval from FDA for its abbreviated new drug application (ANDA) for repaglinide tablets.
Indian generics companies top ANDA approvals
Indian generics companies are beating many other countries when it comes to gaining US FDA approval for their generic drugs.
Use of brand-name drugs increasing healthcare costs in US
Patients with diabetes who are covered by the US healthcare insurance Medicare are two to three times more likely to use expensive brand-name drugs compared to patients treated within the Veterans Affairs Healthcare System [1].
Teva loses fight against generic glatiramer acetate
On 26 July 2013 the US Federal Circuit Court of Appeals invalidated several of Teva’s patents on Copaxone (glatiramer acetate), including one that protected the drug until September 2015.
Generics combo non-inferior to treatment with Enbrel
A study carried out by researchers from the US Department of Veterans Affairs and the Canadian Institutes for Health Research has found that a combination of three generic drugs is non-inferior to treatment with Amgen’s blockbuster biological Enbrel (etanercept) [1].
Generics applications under review by EMA – 2013 Q2
Last update: 6 September 2013
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 27 EU member states and in Norway, Iceland and Liechtenstein. 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].
Enhancing prescribing efficiency in the Republic of Srpska
It has been claimed that countries with smaller populations have difficulties obtaining considerable price reductions for generics. However, evidence from the Republic of Srpska, which is one of the two constitutive entities of Bosnia and Herzegovina, with a population of only 1.43 million, proves otherwise [1].
Ranbaxy faces lawsuit in India
An Indian lawyer has filed a lawsuit asking the Indian Supreme Court to investigate Ranbaxy Laboratories (Ranbaxy), its executives and Indian drug control officers, as well as to shut down two of Ranbaxy’s Indian plants.
Actavis submits ANDAs for two more generics
Actavis has filed for US approval for generic versions of a contraceptive and a sedative/anaesthetic.
