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FDA calls for comment on biosimilars interchangeability Guidelines | Posted 06/02/2015

The US Food and Drug Administration (FDA) wants drugmakers to comment on the information requirements for biosimilars interchangeability.

Generics versus brand-name drugs Generics/Research | Posted 06/02/2015

Is there a benefit to prescribing brand-name drugs versus prescribing generics? The answer appears to be no, according to evidence collected by researchers from the University of British Columbia i...

Impact of nephrology subsequent entry biologics in Canada Biosimilars/Research | Posted 06/02/2015

Subsequent entry biologics (SEBs) may soon be a reality in Canadian nephrology practice. Along with opportunities to reduce healthcare costs, these agents pose unique challenges to successful imple...

Hanwha to transfer biosimilar etanercept technology to Merck Biosimilars/News | Posted 06/02/2015

South Korea’s Hanwha Chemical Corporation (Hanwha) has reportedly signed a contract with US pharma giant Merck to export the technology to make its biosimilar etanercept drug.

EMA recommends suspending generics from GVK Bio Policies & Legislation | Posted 06/02/2015

On 23 January 2015, the European Medicines Agency (EMA) recommended that generics medicines for which authorization in the European Union (EU) was primarily based on clinical studies conducted at I...

Actavis to buy UK generics maker Auden McKenzie Pharma News | Posted 06/02/2015

US generics maker Actavis announced on 26 January 2015 that it had agreed to buy UK generics maker Auden McKenzie. The deal will propel Actavis into the top position in the UK for generics supplier...

Generics still cost more in Canada, but prices decreasing Reports | Posted 06/02/2015

A report issued in December 2014 by Canada’s Patented Medicine Prices Review Board (PMPRB) finds that the prices of generics in Canada have decreased significantly in recent years. However, Canadia...

Akorn submits ANDA for difluprednate ophthalmic emulsion Generics/News | Posted 06/02/2015

US generics maker Akorn has confirmed that it has filed an abbreviated new drug application (ANDA) with the US Food and Drug Administration (FDA) seeking approval to market difluprednate ophthalmic...