Biosimilars
FDA accepts application for Adello’s filgrastim biosimilar
US-based biosimilars specialist Adello Biologics (Adello) announced on 11 September 2017 that the regulatory submission for its proposed filgrastim biosimilar had been accepted by the US Food and Drug Administration (FDA).
FDA Commissioner discusses challenges and opportunities for biosimilars
The US Food and Drug Administration (FDA) approved its first biosimilar for cancer drug Avastin (bevacizumab) in September 2017 [1]. In light of this momentous event, FDA Commissioner Dr Scott Gottlieb spoke to medical reporter Laurie MicGinely, at The Washington Post’s Chasing Cancer Summit, about the challenges faced by biosimilars and the future opportunities in the US.
EMA approval for adalimumab and trastuzumab biosimilars
The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) announced on 15 September 2017 that it had recommended granting marketing authorization for the adalimumab biosimilar Cyltezo and the trastuzumab biosimilar Ontruzant.
Biosimilars for rheumatic diseases
Biologicals have become central to the long-term management of many chronic diseases, including inflammatory rheumatic diseases. Biosimilars may help to fill an unmet need by improving patient access to effective biological treatments for chronic diseases. In light of these facts, authors from Norway reviewed biosimilars for rheumatic diseases [1].
FDA accepts application for rituximab biosimilar from Sandoz
Sandoz, the generics division of Novartis, announced on 12 September 2017 that the regulatory submission for its proposed rituximab biosimilar (GP2013) had been accepted by the US Food and Drug Administration (FDA).
Equivalence of rituximab biosimilar in rheumatoid arthritis
A network meta-analysis was used by researchers from Italy to ‘reinforce the clinical data available’ for the equivalence of the rituximab biosimilar CT‑P10 [1].
Biocon withdraws EU applications for trastuzumab and pegfilgrastim biosimilars
India-based biologicals specialist Biocon announced on 16 August 2017 that it was withdrawing its European Union (EU) marketing applications for its trastuzumab and pegfilgrastim biosimilars.
FDA approves bevacizumab biosimilar Mvasi
On 14 September 2017, the US Food and Drug Administration (FDA) approved its first biosimilar for the treatment of cancer.
Positive phase III results for Pfizer’s trastuzumab biosimilar
Pharma giant Pfizer announced on 10 September 2017 positive results from the pivotal phase III study of its candidate trastuzumab biosimilar. Pfizer says that ‘data from the REFLECTIONS B327-02 study demonstrates equivalence in objective response rate (ORR) for patients with HER2-positive metastatic breast cancer’.
Comparable efficacy and safety observed in patients switched to biosimilar CT-P10
Rituximab is a monoclonal antibody that targets the CD20 protein that is primarily found on B lymphocytes. Through depletion of CD20-positive B cells in the peripheral blood and bone marrow, rituximab is effective for treating some haematological malignancies and immune-mediated diseases such as rheumatoid arthritis (RA). CT-P10 (Truxima) is a biosimilar of the rituximab reference product. It is the first biosimilar to receive market authorization from the European Medicines Agency and is approved in Europe for all indications for which RTX is licensed [1]. A phase I randomized controlled trial (RCT) in patients with RA demonstrated pharmacokinetic equivalence of CT-P10 and reference rituximab over 24 weeks of treatment [2], and comparable efficacy and safety of these two drugs has recently been demonstrated over an extended treatment duration from the same trial [3]. With biosimilars typically being less expensive than originator biologicals [4], it is of interest to know whether patients treated with an originator biological can be switched to a biosimilar to save healthcare costs and increase access without affecting treatment efficacy or safety. An open-label extension (OLE) study that enrolled patients who had completed the aforementioned phase I RCT has been published [5]. The study has demonstrated comparable efficacy and safety profiles in patients who switched from the reference rituximab to CT-P10 and those maintained on CT-P10 throughout treatment [5].
