Generics
Generics applications under review by EMA – April 2016
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 approves first generic rosuvastatin
The US Food and Drug Administration (FDA) announced on 29 April 2016 that it had approved the country’s first generic version of Astra Zeneca’s leading cholesterol drug Crestor (rosuvastatin).
Perceptions of the safety and side effects of generics
A quarter of doctors believe that generics are less safe and cause more side effects than brand-name drugs, according to a study carried out by researchers from New Zealand and the US [1].
FDA approves highest number of generics in 2015
The US Food and Drug Administration (FDA) approved more than 700 generics in 2015, more than in any previous year, according to the annual report from the agency’s Office of Generic Drugs (OGD).
Perceptions of the effectiveness and quality of generics
More than a quarter of doctors and the general public believe that generics are less effective and of poorer quality than brand-name drugs, according to a study carried out by researchers from New Zealand and the US [1].
India’s bulk drug exports on the increase
Driven by exports to both regulated and semi-regulated markets, India’s bulk drug exports are likely to grow at a compound annual growth rate (CAGR) of 12–14% up to 2018–2019, according to a recent study.
Generics perceptions in patients, pharmacists and doctors
A significant proportion of the general public, pharmacists and doctors have negative perceptions about generics, according to a study carried out by researchers from New Zealand and the US [1].
Sun Pharma to buy 14 drug brands from Novartis in Japan
A wholly owned subsidiary of India’s Sun Pharmaceutical Industries (Sun Pharma) will acquire a portfolio of 14 established prescription brands from Novartis and Novartis Pharma in Japan for a sum of US$293 million. This will give Sun Pharma a strong foothold in Japan, the world’s second largest market after the US.
Substitution of generic antiepileptic drugs
Despite the availability of generic antiepileptic drugs (AEDs), patients and neurologists still hesitate to make a switch due to several reasons.
Apotex launches generic of nasal allergy treatment
On 24 March 2016, Canada-based Apotex announced that it had launched mometasone furoate monohydrate nasal spray in the US, the first generic version of Merck’s Nasonex. Mometasone furoate monohydrate is a once-daily anti-allergen indicated for the treatment of nasal congestion for adults and children over two years.
