Biosimilars

EMA approval for etanercept and rituximab biosimilars

Biosimilars/News | Posted 28/04/2017

The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) announced on 21 April 2017 that it had recommended granting marketing authorization for the etanercept biosimilar Erelzi and for the rituximab biosimilars Rixathon and Riximyo.

Prospective study finds switching to biosimilar infliximab safe

Biosimilars/Research | Posted 28/04/2017

A study of the infliximab biosimilar Remsima has, according to the authors, shown similar ‘safety and survival’ of biosimilar infliximab Remsima compared to the originator biological Remicade [1].

Fujifilm ramps up biosimilars production as UK court allows Humira biosimilar

Biosimilars/General | Posted 28/04/2017

A UK court has ruled in the favour of Japan-based Fujifilm Kyowa Kirin Biologics’ Humira biosimilar. The Fujifilm corporation has also announced a multi-million-dollar investment in its biologicals production facilities in the US.

Rituximab biosimilar safe in advanced follicular lymphoma patients

Biosimilars/Research | Posted 21/04/2017

A study of the rituximab biosimilar CT‑P10 has, according to the authors, ‘demonstrated’ similar pharmacokinetics (PK) and safety when administered in combination with cyclophosphamide, vincristine and prednisone (CVP) in patients with newly diagnosed advanced follicular lymphoma (AFL) [1].

Advances in ranibizumab and teriparatide biosimilars

Biosimilars/News | Posted 21/04/2017

Positive results have been reported from a ranibizumab biosimilar and a teriparatide biosimilar has entered phase III trials.

Biosimilars of certolizumab pegol

Biosimilars/General | Posted 21/04/2017

Certolizumab pegol is a monoclonal antibody directed against tumour necrosis factor-alfa (TNF-α). More precisely, it is a PEGylated Fab’ fragment of a humanized TNF inhibitor monoclonal antibody. It is indicated for the treatment of Crohn’s disease, rheumatoid arthritis, psoriatic arthritis and ankylosing spondylitis.

Harmonization of requirements for NBCDs across regions

Biosimilars/Research | Posted 21/04/2017

Efforts are being undertaken to continuously develop and harmonize the regulatory requirements for complex medicinal products across regions. Taking this into account, authors Ehmann and Pita believe the European Union (EU) network is ready for non-biological complex drugs (NBCDs) [1].

US pharmacists’ views on the naming and labelling of biologicals

Biosimilars/Research | Posted 14/04/2017

The Alliance for Safe Biologic Medicines (ASBM) has published the results of a survey determining the opinions of US pharmacists about the naming and labelling of biosimilars [1].

Trastuzumab biosimilar submitted for approval in Japan

Biosimilars/News | Posted 14/04/2017

Japan-based Nippon Kayaku announced on 11 April 2017 that it had submitted an application for its trastuzumab biosimilar, CT-P6, to the Ministry of Health, Labour and Welfare (MHLW) in Japan.

Italian study compares epoetin biosimilars and originator biologicals

Biosimilars/Research | Posted 14/04/2017

Recently, extensive discussion on the opportunity offered by biosimilars for the sustainability of the National Health Services has taken place in academic and regulatory contexts. The use of biosimilars continues to be limited, and the scepticism of prescribers and patients seem to be linked to the uncertainty of the risk-benefit profile of biosimilars. In the case of epoetins, used in the management of anaemia in the nephrology and oncology settings, the results of a recent study showed no difference between biosimilars and originators on relevant effectiveness and safety outcomes [1].