Biosimilars/News

Greece says no to automatic substitution of biologicals

Biosimilars/News | Posted 15/03/2013

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

Biosimilars/News | Posted 08/03/2013

Japan has granted regulatory approval to a second biosimilar granulocyte colony-stimulating factor (G-CSF).

XBiotech moves into biosimilars

Biosimilars/News | Posted 08/03/2013

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

Biosimilars/News | Posted 01/03/2013

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

Biosimilars/News | Posted 01/03/2013

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

Biosimilars/News | Posted 03/02/2012

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

Biosimilars/News | Posted 22/02/2013

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

Biosimilars/News | Posted 22/02/2013

Pharma Giant Merck announced on 20 February 2013 that it had made a deal to develop and commercialize biosimilars with Samsung Bioepis.

AMAC and GPhA hit back at Big Pharma over biosimilars

Biosimilars/News | Posted 15/02/2013

The Association of Mature American Citizens (AMAC) and the Generic Pharmaceutical Association (GPhA) have reacted strongly to the actions by Amgen and Genentech, which aim to make it more difficult for patients to get access to biosimilar medicines [1].

Biotech firms try to limit biosimilar substitution in US

Biosimilars/News | Posted 08/02/2013

FDA is still to approve a biosimilar and has yet to issue final guidelines outlining the regulatory requirements for approval of a biosimilar in the US.