Glycosylation main approval issue with biosimilars

Home/Conferences | Posted 01/09/2009

Post-translational modifications (PTMs), particularly glycosylation, will play a critical role in how biosimilars – also called follow-on biologics or biogenerics – and will eventually be approved in the US. This stated science writer Mr Angelo DePalma in Genetic Engineering & Biotechnology News of 1 February 2009.

Building trust in biosimilars main challenge of EGA

Home/Conferences | Posted 01/09/2009

So far, three types of biosimilar medicines have been approved in the EU – somatropin (human growth hormone, hGH), epoetin (erythropoietin, EPO) and filgrastim (granulocyte colony-stimulating factor, G-CSF)) – in the form of 13 marketing authorisations from various companies under many different names.

DIA EuroMeeting: EU needs automatic pricing to get generics to market

Home/Conferences | Posted 01/09/2009

“The EU needs greater regulatory capacity and automatic pricing and reimbursement to deal with the number of generics required to serve the market”, said Mr Georg Stark, Joint Managing Director of Alfred E Tiefenbacher GmbH & Co, speaking at the Drug Information Association (DIA) 21st Annual EuroMeeting held in Berlin, Germany, from 23-25 March 2009.