Biosimilars/News
Sandoz starts phase III trials for biosimilar filgrastim and pegfilgrastim
On 19 January 2012, Sandoz, the generic drug division of Swiss drug giant Novartis AG, announced that it had started two phase III clinical trials, one for biosimilar filgrastim (Amgen’s Neupogen) for the US market and the other for its global pegfilgrastim (Amgen’s Neulasta) development programme.
Roche encounters manufacturing issues with epoetin-beta
The Spanish regulatory agency has found deviations in the quality of the manufacture of Switzerland-based F. Hoffmann-La Roche’s biological anaemia treatment Mircera (methoxy polyethylene glycol-epoetin beta), a long acting erythropoiesis-stimulating agent; and is recommending patients to change to other epoetins.
Baxter and Momenta make biosimilars deal
Baxter International (Baxter) and Momenta Pharmaceuticals (Momenta) announced on 22 December 2011 that they had entered into a global collaboration agreement to develop and commercialise biosimilars.
Amgen finally jumps on biosimilars bandwagon
Biotech giant Amgen and US generics manufacturer Watson Pharmaceuticals (Watson) announced on 19 December 2011 that the two companies had agreed to collaborate on the development and commercialisation of several cancer antibody biosimilars.
Hospira starts phase III programme for biosimilar erythropoietin
Hospira, self-proclaimed leader in injectable generics, announced on 9 January 2012 that the company had enrolled the first patient in its phase III programme in the US for its biosimilar erythropoietin (EPO).
First biosimilar G-CSF in Japan
Mochida Pharmaceuticals (Mochida) and development partner Fuji Pharma announced on 26 December 2011 that they had filed respective applications for the first biosimilar granulocyte colony-stimulating factor (G-CSF) in Japan.
Samsung makes biosimilars deal with Biogen Idec
Korean electronics giant Samsung announced on 6 December 2011 that it had entered into a biosimilars joint venture with US biotechnology company Biogen Idec (Biogen).
Indian Transgene sells biosimilar to German TSS Export
India-based biotech company Transgene Biotek Limited (Transgene) announced on 24 November 2011 the sale of technology for biosimilar recombinant human erythropoietin (rh-EPO) to TSS Export GmbH FZE, part of the Germany-based TSS group, for US$5 million (Indian Rupees 260 million).
National Psoriasis Foundation declares biosimilar stance
One of the leading psoriasis patient associations in the US, the National Psoriasis Foundation, has publically declared its stance on biosimilars. In an open letter to FDA, the Foundation issued a statement on the implementation of the Biologics Price Competition and Innovation (BPCI) Act of 2009 [1].
Fujifilm and Kyowa Hakko Kirin in biosimilars joint venture
Japanese Fujifilm Corporation announced on 16 November 2011 that it is once again making an agreement in the biosimilars field, this time with biotech firm Kyowa Hakko Kirin, Tokyo, Japan.
