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European patent will make medicines cheaper Pharma News | Posted 06/10/2009

Big pharmaceutical concerns manage to keep out cheaper medicines, even if the patents have expired. These firms would not be so good at this if a European patent would exist, says Mr André den Exte...

Big pharmaceutical firms start to embrace generics Generics/Research | Posted 06/10/2009

President Barack Obama recently posed an existential question to those around him. “If there’s a blue pill and a red pill, and the blue pill is half the price of the red pill and works just as well...

China to globalise its successful domestic biosimilars market Biosimilars/News | Posted 05/10/2009

The fearsome darling of the pharmaceutical industry, China, has marketers salivating over the 20%-plus annual growth, which could position the country as the world’s third-largest pharmaceutical ma...

Regulatory reflections on the FDA’s guidance on biosimilars and follow-on branded biologics Guidelines | Posted 05/10/2009

With US Congressional actions on biosimilar/follow-on biologics approaching, the FDA has issued a Guidance regarding the use of pens, jets, and other related injectors (see Draft Guidance for Indus...

US House panel adopts 12 years’ biologicals exclusivity Biosimilars/News | Posted 01/10/2009

The powerful US House Committee on Energy and Commerce (HCEC) has voted to give branded biological drugs 12 years’ market exclusivity from generic competition, but also to ban ‘pay-for-delay’ settl...

Biosimilars to be held up 0 to 13.5 years under new US bill Biosimilars/News | Posted 01/10/2009

A bill submitted to the US Senate proposes granting up to thirteen and half years of exclusivity to biological drugs. Under the plan, the branded products would receive at least nine years of exclu...

EU will act against drugmakers that delay generics Reports | Posted 30/09/2009

The European Commission (EC) released its final report on 8 July 2009 concerning competition in the pharmaceutical sector, and said it will increase its oversight of the industry after finding that...

US and EU get tough on 'pay-for-delay’ deals Generics/News | Posted 30/09/2009

Forces are aligning against ‘pay-for-delay’ patent deals, reported FiercePharma. After years of expressing contempt for the US Federal Trade Commission's (FTC) fight against the deals, the US Depar...