Biosimilars/News
Sandoz’s biosimilar rituximab on track
The development of a biosimilar version of Rituxan (rituximab) is proceeding as planned, Sandoz’s Global Head, Mr Jeff George told Bloomberg.
When will the US biosimilars pathway be used
FDA Commissioner Margaret Hamburg presented the latest statistics on the US biosimilar pathway during a speech at the Massachusetts Biotechnology Council’s (MassBio) Annual Meeting on 15 March 2013.
Greece says no to automatic substitution of biologicals
Greece’s Medicines Agency (National Organization for Medicines, Ethnikos Organismos Farmakon, EOF) released a document on 13 March 2013 recommending against automatic substitution/interchangeability of reference biologicals and their biosimilars.
Japan approves second biosimilar G-CSF
Japan has granted regulatory approval to a second biosimilar granulocyte colony-stimulating factor (G-CSF).
XBiotech moves into biosimilars
US-based biotech company XBiotech announced on 26 February 2013 that the company would be expanding its portfolio to include biosimilars.
Mylan and Biocon to partner on insulin products
Generics giant Mylan announced on 13 February 2013 that it had entered into an agreement with India-based Biocon to develop and market Biocon’s biosimilar versions of three insulin analogue products.
Oncobiologics and Viropro make biosimilar deal
US-based Oncobiologics and monoclonal antibody developer Viropro announced on 25 February 2013 that they had signed a biosimilar collaboration agreement between the two companies.
Production of 24 biogeneric products in Iran by 2012
According to reports on Iran’s English-language television network, Press TV, Iran is making significant advances in biogeneric products and biotechnology drugs and is planning to start the production of 24 additional biogeneric products drugs by the end of 2012.
Amgen’s response to biosimilar substitution legislation in US
Amgen, in a statement issued on 1 February 2013, has hit back at accusations that the biotech giant is attempting to limit the uptake of biosimilars in the US by backing state bills, which constrain the use of biosimilars.
Merck makes biosimilars deal with Samsung Bioepis
Pharma Giant Merck announced on 20 February 2013 that it had made a deal to develop and commercialize biosimilars with Samsung Bioepis.