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Concerns from EU and US over Colombian biologicals guidelines Guidelines | Posted 19/09/2014

On 21 January 2013, the Colombian Ministry of Health and Social Protection (Ministerio de Salud y Protección Social de Colombia) released a new draft guideline for biologicals, including 'productos...

Biosimilars of trastuzumab Biosimilars/General | Posted 19/09/2014

Last update: 2 June 2017Trastuzumab is a monoclonal antibody that interferes with the human epidermal growth factor receptor 2 (HER2)/neu receptor. In some cancers, notably certain types of br...

Pegteograstim biological approved in South Korea Biosimilars/News | Posted 19/09/2014

South Korean biologicals company, Green Cross, announced on 18 August 2014 that it had received marketing authorization from South Korea’s Ministry of Food and Drug Safety (MFDS) for its pegte...

FDA approvals for generic AIDs and testosterone drugs Generics/News | Posted 19/09/2014

The US Food and Drug Administration (FDA) has approved generic versions of drugs to treat appetite loss in AIDs patients and a testosterone gel treatment for men.

Patient access to rituximab in emerging markets Biosimilars/Research | Posted 19/09/2014

A Pfizer-sponsored study looking at access to the oncology treatment rituximab has revealed that use of this important drug would increase across all therapy types and markets if a biosimilar was a...

Generics applications under review by EMA – August 2014 Generics/General | Posted 19/09/2014

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 centrali...

Biosimilars in emerging markets Reports | Posted 19/09/2014

Less strict or ‘relaxed’ regulatory requirements for biosimilars in some emerging markets are driving the proliferation of non-originator biologicals [1].

Cipla and S&D Pharma make generics deal for Czech Republic and Slovakia Pharma News | Posted 19/09/2014

India-based generics maker Cipla has partnered with S&D Pharma to launch affordable, high quality generics in the Czech Republic and Slovakia.