Biosimilars/News
FDA accepts application for etanercept biosimilar
Sandoz, the generics division of Novartis, announced on 2 October 2015 that the US Food and Drug Administration (FDA) had accepted its application for its etanercept biosimilar (GP2015).
Another infliximab switching trial started
In The Netherlands another study has been initiated into the effects of switching patients from originator infliximab to biosimilar infliximab.
Biosimilar production in Malaysia
Malaysian biotech firm Inno Bio Ventures has announced the signing of a memorandum of understanding (MoU) with Iranian firm Aryogen Biopharma. The agreement will lead to the production of the first Malaysian-made biosimilars for the local and regional market.
Biosimilar insulin launched in the UK
Eli Lilly and Boehringer Ingelheim announced on 26 August 2015 the UK launch of their biosimilar insulin glargine, Abasaglar.
Zarxio first biosimilar to be launched in US
The US has entered a new era in medicines with the historic launch of the country’s first biosimilar. Sandoz, the generics division of Novartis, announced on 3 September 2015 that it had launched its filgrastim biosimilar, Zarxio (filgrastim-sndz), in the US.
Darbepoetin alfa ‘similar biologic’ launched in India
India-based Hetero, one of the largest manufacturers and suppliers of active pharmaceutical ingredients (APIs) to the Indian pharmaceutical industry, announced on 18 June 2014 the launch of its first ‘similar biologic’ product Actorise, a ‘similar biologic’ of darbepoetin alfa in India.
Rituximab similar biologic launched in India
India-based generics maker Hetero Group (Hetero) announced on 3 August 2015 the launch of its product Maball, a ‘similar biologic’ of rituximab, in India.
Non-originator infliximab approved in Russia
South Korean biotechnology company Celltrion announced that it had received approval for its non-originator infliximab, Remsima, from Russia’s Ministry of Health (Министерство здравоохранения Российской Федерации; Rosminzdrav) on 13 July 2015.
Biosimilars licensing agreements for AMP and Formycon
German biosimilars companies AMP Biosimilars (AMP) and Formycon have both made out-licensing agreements for their candidate biosimilars.
Ranibizumab similar biologic launched in India
Indian generics maker Intas Pharmaceuticals (Intas) announced on 19 June 2015 the launch of its ranibizumab similar biologic in India.
