Biosimilars/News
Sandoz applies for Japanese approval for biosimilar G-CSF
Novartis generics unit Sandoz announced on 25 April 2013 that it has filed an application with the Japanese health authority – Pharmaceuticals and Medical Devices Agency (PMDA) – for marketing authorization of EP2006, a biosimilar version of recombinant human granulocyte colony-stimulating factor (G-CSF).
Biosimilars agreements for Hospira and mAbxience
In line with Hospira’s strategy of expansion into biosimilars, the injectable generics specialist announced on 29 April 2013 that it had entered into a collaborative arrangement for several biosimilar products with NovaQuest Co-Investment Fund I, L.P. (NovaQuest).
Hospira marks five years of biosimilars
Self-proclaimed world leader in injectable drugs, Hospira, commemorated five years of providing biosimilars to the European market at the BIO International Convention in Chicago, USA, on 24 April 2013.
Celltrion stops phase III trial of biosimilar rituximab
South Korean biotechnology company Celltrion has stopped the late-stage trial of its biosimilar version of Roche’s blockbuster arthritis/non-Hodgkin’s lymphoma drug MabThera/Rituxan (rituximab).
Cipla launches first etanercept ‘similar biologic’ in India
India-based generics manufacturer Cipla announced on 17 April 2013 the launch of its ‘similar biologic’ product Etacept, the first ‘similar biologic’ of etanercept in India.
Lonza not backing out on biosimilars
Lonza has made a statement refuting reports that the Switzerland-based company was considering backing out of its biosimilars joint venture with Israeli generics giant Teva Pharmaceutical Industries (Teva).
Amgen’s biosimilar plans
Amgen was one of the first companies to recognize the potential of modern biotechnology and this has made it the world’s largest independent biotechnology firm.
Lonza/Teva biosimilar pact in jeopardy
Switzerland-based API producer and custom manufacturing organization Lonza is reviewing whether it is still worth investing in its joint venture for biosimilars with Israeli generics giant Teva Pharmaceutical Industries (Teva).
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.
