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Positive phase III data for Amgen adalimumab biosimilar Biosimilars/Research | Posted 20/02/2015

US biopharmaceutical giant Amgen announced on 3 February 2015 positive results from its phase III clinical trial for a biosimilar version of adalimumab in patients suffering from rheumatoid arthritis.

Pfizer sets to lead biosimilars and generics markets Pharma News | Posted 20/02/2015

Pharma giant Pfizer has announced it is to buy injectable generics specialist and biosimilars maker Hospira for US$17 billion. The products acquired in the deal will be integrated into Pfizer’s gen...

FDA calls for comment on generics user fees guidelines Guidelines | Posted 20/02/2015

The US Food and Drug Administration (FDA) announced in a Federal register publication of 6 February 2015 the reopening of the docket to solicit public comment on certain topics related to implement...

Generics gaining ground in French pharmaceutical market Reports | Posted 20/02/2015

The French pharmaceutical market is forecast to grow by a miniscule amount in the coming years due to the growing influence of generics in the country.

Hospira and Pfenex to collaborate on ranibizumab biosimilar Biosimilars/News | Posted 20/02/2015

US-based injectables specialist Hospira and US biotechnology firm Pfenex announced on 10 February 2015 that they had entered into an agreement to exclusively develop and commercialize for worldwide...

Mylan being sued over sorafenib generic Generics/News | Posted 20/02/2015

US-based Mylan is coming under fire from German pharma giant Bayer, as the generics maker is sued for violating patents on Bayer’s liver and kidney cancer drug Nexavar (sorafenib).

Biosimilars compared to generics in the European market Biosimilars/Research | Posted 13/02/2015

Once a patent expires, price competition is possible since any manufacturer can copy the originator product. This circumstance justifies the place in the pharmaceutical market for generics and bios...

FDA advisers to consider infliximab biosimilar Biosimilars/News | Posted 13/02/2015

The US Food and Drug Administration (FDA) revealed in a Federal Register publication on 10 February 2015 that it has asked advisers to review a second biosimilar application.