Biosimilars
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.
Prospects for producing follow-on biological products in Brazil
New research shows the need for local production of biologicals in Brazil in order to offset the increasing medicines budget and reduce the trade deficit when it comes to drugs [1].
US FDA defends biosimilar substitution
US FDA Commissioner Margaret Hamburg defended the substitution of interchangeable biosimilars at the Generic Pharmaceutical Association (GPhA) Annual Meeting which was held in Orlando, Florida, USA, on 20–22 February 2013.
MS patient dies from immunogenicity to biological drug
A Swedish woman diagnosed with multiple sclerosis (MS) appears to have died after developing unwanted immunogenicity toward the biological drug Tysabri (natalizumab), according to a report in the journal Neurology [1].
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.
Assessment of interchangeability under the BPCI Act
The Biologics Price Competition and Innovation (BPCI) Act gives FDA the authority to designate a biosimilar as interchangeable with its reference product. This means that the biosimilar may be substituted for the originator product by the pharmacist without reference to the prescribing physician [1]. The criteria for establishing interchangeability of biosimilars, despite FDA issuing three draft guidance documents, are still not clear [2].
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.
The ethics of biosimilars
Biosimilars in the EU have to undergo a strictly regulated comparability exercise against the reference medicinal product on the physicochemical, analytical, functional, non-clinical and clinical level. Only if a biosimilar is a close copy of the reference medicine will it be approved as a biosimilar [1]. Despite this fact, however, ethical issues have been raised on the use of granulocyte colony-stimulating factor (G-CSF, filgrastim) in healthy volunteers by the European Group for Blood and Marrow Transplantation (EBMT) and the World Marrow Donor Association (WMDA).
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.
