Biosimilars

Biosimilars of pegfilgrastim

Biosimilars/General | Posted 31/10/2014

Last update: 15 January 2021

Pegfilgrastim is a PEGylated form of the recombinant human granulocyte colony-stimulating factor (G-CSF) analogue filgrastim. It serves to stimulate the level of white blood cells (neutrophils). Pegfilgrastim treatment can be used to stimulate bone marrow to produce more neutrophils (white blood cells) to fight infection in patients undergoing chemotherapy.

LG Life Sciences and Mochida make deal for adalimumab biosimilar

Biosimilars/News | Posted 31/10/2014

South Korea-based LG Life Sciences and Japan-based Mochida Pharmaceutical (Mochida) announced on 15 October 2014 that they had signed a deal to co-develop and commercialize an adalimumab biosimilar for the Japanese market.

Study results show safety of switching to biosimilar infliximab

Biosimilars/Research | Posted 31/10/2014

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

Biosimilars/Research | Posted 24/10/2014

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

Biosimilars/Research | Posted 24/10/2014

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

Biosimilars/News | Posted 24/10/2014

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

Biosimilars/Research | Posted 17/10/2014

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

Biosimilars/News | Posted 17/10/2014

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

Biosimilars/Research | Posted 10/10/2014

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

Biosimilars/News | Posted 10/10/2014

German pharma giant Merck KGaA announced on 18 September 2014 plans to step up investments in biosimilars during 2015.