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Stada in-licenses biosimilar filgrastim Biosimilars/News | Posted 08/11/2013

German generics giant Stada Arzneimittel (Stada) announced on 28 October 2013 that it was strengthening its activities in the biosimilars area by in-licensing a biosimilar filgrastim product from C...

South African HCPs told to ‘get their facts straight’ on generics Generics/General | Posted 08/11/2013

The South African National Association of Pharmaceutical Manufacturers (NAPM) urged healthcare professionals (HCPs) to ‘get their facts straight’ with respect to generics at a special workshop held...

EGA commends EMA workshop on biosimilars guidelines Biosimilars/General | Posted 08/11/2013

The European Generic medicines Association (EGA) has congratulated the European Medicines Agency (EMA) on its organization of the EMA workshop on biosimilars and urges rapid adoption of its revisio...

Good news for Ranbaxy plant in US Generics/News | Posted 08/11/2013

Ranbaxy Laboratory’s (Ranbaxy) US-based plant, Ohm Laboratories (Ohm), has successfully passed an FDA inspection, according to an announcement on the generic drugmaker’s website.

Calls for biosimilars to have same INN at WHO meeting Biosimilars/General | Posted 31/10/2013

Last update: 7 February 2014 The World Health Organization (WHO) held its 57th Consultation on International Nonproprietary Names (INNs) for Pharmaceutical Substances on 22 October 2013 in Gen...

Clinical trials for follow-on biological products in Brazil Biosimilars/Research | Posted 31/10/2013

Unlike for generic drugs, authorizing biosimilars without conducting quality clinical trials represents a real threat to patients, according to Professor Valderílio Feijó Azevedo, Professor of Rheu...

Canada-EU trade deal will extend patents for two years Generics/General | Posted 31/10/2013

On 18 October 2013, Canada and the European Union (EU) reached agreement on a trade deal, which will free the movement of goods, services, investment and labour between the two regions, but has bee...

FDA extends biosimilars deadlines due to US shutdown Biosimilars/General | Posted 31/10/2013

As a result of the US government shutdown, the US Food and Drug Administration (FDA) has extended the deadlines and goal dates for its biosimilars activities.