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].
Second etanercept biosimilar approved in Canada
Sandoz, the generics division of Novartis, announced on 21 August 2017 that its etanercept biosimilar, Erelzi, is now available in Canada.
Biosimilars applications under review by EMA – August 2017
The European Medicines Agency (EMA) is the body responsible for approval of biosimilars within the European Union (EU). A legal framework for approving biosimilars was established in 2003. Approval of biosimilars is based on an abbreviated registration process, which allows biosimilars manufacturers to provide a reduced package of information compared to originator drugs, provided they can prove ‘similarity’ to the originator or reference drug.
WHO launches consultation on prequalification of biosimilars
The World Health Organization (WHO) announced in September 2017 that it would be launching its pilot project for prequalifying biosimilars in October 2017. The step is intended to make ‘some of the most expensive treatments for cancer more widely available in low- and middle-income countries’.
Sanofi receives tentative FDA approval for insulin lispro biosimilar
Pharma giant Sanofi announced on 1 September 2017 that it had received tentative approval for Admelog, its insulin lispro biosimilar, from the US Food and Drug Administration (FDA).
Positive phase III results for Amgen’s trastuzumab biosimilar
Biotech giant Amgen and partner Allergan announced on 9 September 2017 positive data from a phase III study of their trastuzumab biosimilar (ABP 980) compared to Herceptin (trastuzumab).
Positive phase I results for rituximab biosimilar CT-P10 in patients with rheumatoid arthritis
Rituximab is an established anti-CD20 monoclonal antibody used for the treatment of some haematological cancers and immune-mediated diseases, such as rheumatoid arthritis (RA). CT-P10 (Truxima) is the first biosimilar of the rituximab reference product and was approved in Europe for all licensed RTX indications in February 2017 [1]. A phase I randomized controlled trial (RCT) of CT-P10 versus reference rituximab in patients with active RA demonstrated that the two drugs had equivalent pharmacokinetics after a single course of treatment and that their efficacy, pharmacodynamics, immunogenicity and safety were comparable up to Week 24 [2]. To allow comparison of CT-P10 versus reference rituximab, patients in the same phase I trial received a second course of treatment and were evaluated for efficacy, safety, pharmacokinetics, pharmacodynamics, and other clinical data for up to 72 weeks. These data demonstrate that the clinical profile of CT-P10 is comparable to reference rituximab in patients with RA over an extended treatment duration [3].
Two trastuzumab biosimilars submitted to FDA
Two different groups announced that their trastuzumab biosimilars had been successfully submitted to the US Food and Drug Adminstration (FDA) for review.
