Biosimilars
Study results show safety of switching to biosimilar infliximab
US-based Epirus Biopharmaceuticals (Epirus) announced on 23 September 2014 positive week 58 follow-up data from its global phase III study for its biosimilar infliximab (BOW015). Results of the open label phase, which was carried out in rheumatoid arthritis patients, demonstrated comparable safety and efficacy compared to the originator product (Remicade).
Extrapolation for biosimilars
Regarding extrapolation* of indications for biosimilars, the European Medicines Agency (EMA) has stated that ‘if clinical similarity can be shown in a key indication, extrapolation of efficacy and safety data to other indication(s) of the reference product may be possible’ under certain conditions [1].
Biosimilar bevacizumab similar to Avastin in preclinical assessments
Preclinical assessments have demonstrated the similarity of biologicals major Amgen’s biosimilar bevacizumab candidate (ABP 215) to Avastin [1].
Norwegian study may be slowing adoption of biosimilar infliximab
Norway is funding clinical studies in which patients will be switched from originator biological drugs to biosimilars [1]. However, some have speculated that the NOR-SWITCH study is actually slowing the adoption of biosimilar infliximab in Norway.
Mobilization of stem cells by biosimilar Nivestim and Neupogen
Comparison of biosimilar granulocyte colony-stimulating factor (G-CSF), Nivestim and originator G-CSF, Neupogen (filgrastim), showed no statistical differences when used for the mobilization of peripheral blood stem cells in patients treated for haematological malignancies [1].
Stada in-licenses teriparatide biosimilar
German generics giant Stada Arzneimittel (Stada) announced on 13 October 2014 that it had made a deal to in-licensing a teriparatide biosimilar.
Phase III study of biosimilar adalimumab meets primary endpoint
Biologicals major Amgen announced on 8 October 2014 the first late-stage data from its biosimilars programme. Primary efficacy analysis from a phase III trial of Amgen’s adalimumab biosimilar (ABP 501) compared with Humira (adalimumab) has demonstrated ‘clinical equivalence’.
Merck KGaA plans further investment in biosimilars
German pharma giant Merck KGaA announced on 18 September 2014 plans to step up investments in biosimilars during 2015.
Epirus and Livzon collaborate on copy biologicals for China
US-based Epirus Biopharmaceuticals (Epirus) announced on 25 September 2014 that it had signed a collaboration agreement with Chinese biotechnology company Livzon Mabpharm (Livzon).
Infliximab ‘similar biologic’ receives Indian approval
US-based biologicals company Epirus Biopharmaceuticals (Epirus) announced on 15 September 2014 that it had received final marketing and manufacturing approvals for its infliximab similar biologic, BOW015, from the Drug Controller General of India (DCGI).
