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EU guidelines for nanosimilars Guidelines | Posted 11/10/2013

Last update:  5 November 2013 The regulatory body for approval of medicines in the European Union (EU) is the European Medicines Agency (EMA). The agency is responsible for the scientific...

Increased use of generics could save South Africa millions Reports | Posted 11/10/2013

Increasing the use of generics by 5% could save the healthcare industry and patients in South Africa in excess of Rand 400 million per year, according to a report from the country’s pharmaceutical...

US state legislation on biosimilars substitution Policies & Legislation | Posted 11/10/2013

Despite the fact that the US Food and Drug Administration (FDA) has yet to receive a biosimilars application, many US states have been considering legislation on biosimilars substitution [1].

Australians pay too much for generics Generics/General | Posted 11/10/2013

According to the Consumers Health Forum of Australia (CHF), a body which represents healthcare consumers, Australians are paying way too much for their generic drugs.

India approves Mylan’s purchase of Agila Pharma News | Posted 11/10/2013

Generics giant Mylan announced on 3 September 2013 that its proposed acquisition of generics injectables maker Agila Specialties (Agila) from Strides Arcolab for Rs 5,168-crore (US$1.6 billion...

FDA approves generic version of cancer drug Generics/News | Posted 11/10/2013

FDA announced on 16 September 2013 that it had approved Teva Pharmaceutical Industries (Teva’s) generic version of Roche’s cancer drug Xeloda (capecitabine).

India’s drug regulator finds no problem at Ranbaxy sites Policies & Legislation | Posted 11/10/2013

India’s drug regulator has found no major discrepancies at the Mohali manufacturing unit of Ranbaxy Laboratories (Ranbaxy) in contrast to FDA findings.

More immunogenicity data needed for biosimilar mAbs Biosimilars/Research | Posted 04/10/2013

Eight therapeutic monoclonal antibodies (mAbs) will lose EU and US patent protection before 2020, making way for a new class of biosimilar. The promise of biosimilar mAbs is enticing, but these are...