Biosimilars

European perspective on biosimilars

Biosimilars/Research | Posted 27/10/2017

In the European Union (EU), a legal framework for approving biosimilars was established in 2003. The first biosimilar Omnitrope (somatropin) was approved in 2006 [1].

FDA launches educational campaign for biosimilars

Biosimilars/General | Posted 27/10/2017

In light of the increasing number of biosimilars becoming available in the US, the US Food and Drug Administration (FDA) announced on 23 October 2017 the launch of its education campaign for biosimilars.

Anti-drug antibody assays for biosimilars and originator biologicals

Biosimilars/Research | Posted 27/10/2017

Biosimilar drug development has brought new challenges to bioanalytical ligand-binding assays used to determine drug concentration, anti-drug antibodies and neutralizing antibodies.

Novo Nordisk petitions FDA to require clinical trials for Victoza biosimilars

Biosimilars/News | Posted 27/10/2017

Danish pharmaceutical company Novo Nordisk has asked the US Food and Drug Administration (FDA) to require clinical trials for biosimilar applications for its blockbuster diabetes drug Victoza (liraglutide).

Challenges and opportunities in producing biosimilars

Biosimilars/Research | Posted 20/10/2017

In a viewpoint article published in ACS Medicinal Chemistry Letters [1], Dahodwala and Sharfstein discuss the challenges and opportunities faced by biopharmaceutical manufacturers in producing biosimilars, equivalent versions of therapeutic proteins, and the role of regulatory agencies, particularly the US Food and Drug Administration (FDA), in approving these compounds.

FDA delays approval of Biocon/Mylan’s pegfilgrastim biosimilar

Biosimilars/News | Posted 20/10/2017

India-based biologicals specialist Biocon announced on 10 October 2017 that it has been informed by the US Food and Drug Administration (FDA) that its pegfilgrastim biosimilar, which it is developing jointly with Mylan, cannot be approved at present.

Bevacizumab improves survival in NSCLC patients

Biosimilars/Research | Posted 20/10/2017

In what could be good news for recently approved bevacizumab biosimilar Mvasi, a study has shown that bevacizumab-containing regimens improve survival in advanced non-squamous non–small cell lung cancer (NSCLC) patients.

Amgen’s adalimumab biosimilar will only be launched in US in 2023

Biosimilars/News | Posted 20/10/2017

US-based biotech giant Amgen and pharma giant AbbVie announced on 28 September 2017 that they had reached a ‘global resolution’ ending all patent litigation regarding AbbVie’s blockbuster arthritis drug Humira (adalimumab).

NHS England to increase biosimilar usage

Biosimilars/General | Posted 20/10/2017

On 12September 2017, National Health Service (NHS) England released a ‘Commissioning framework for biological medicines (including biosimilar medicines)’. In this document, they make a series of recommendations with the aim of increasing both biological and biosimilar uptake. As a result of increased competition between biologicals, creating better value biological medicines and biosimilars, NHS England believes that it can make savings of GBP 200 − GBP 300 million a year by 2020/21 by increasing uptake of these better value biologicals.

EMA accepts application for pegfilgrastim biosimilar from Cinfa

Biosimilars/News | Posted 13/10/2017

Spanish biosimilars developer Cinfa Biotech (Cinfa) announced on 4 October 2017 that its application for approval for its proposed pegfilgrastim biosimilar (B12019) had been accepted by the European Medicines Agency (EMA).

Adalimumab biosimilar ABP 501 shows similar efficacy, safety and immunogenicity

Biosimilars/Research | Posted 13/10/2017

Biosimilars are defined by the US Food and Drug Administration (FDA) as a biological product that is ‘highly similar to’ an approved biological product (the ‘reference’ or ‘originator’ or ‘bio-originator’ product) and that has ‘no clinically meaningful differences’ in safety or effectiveness compared to the reference product.

Nichi-Iko gains Japanese approval for infliximab biosimilar

Biosimilars/News | Posted 13/10/2017

Japan-based generics maker Nichi-Iko Pharmaceutical (Nichi-Iko) announced on 27 September 2017 that it had gained Japanese approval for its infliximab biosimilar.

Barriers to access to biosimilars

Biosimilars/Research | Posted 13/10/2017

Barriers to the use of biosimilars include healthcare professional and patient opinions. But national and local guidelines, levels of funding and differing approaches to healthcare management can also influence access to biosimilars in different Member States of the European Union (EU), according to authors from the National Advisory Unit on Rehabilitation in Rheumatology and the Rheumatology Department of Diakonhjemmet Hospital, Oslo, Norway [1].

JCR files for Japanese approval of agalsidase beta biosimilar

Biosimilars/News | Posted 06/10/2017

Japan-based JCR Pharmaceuticals (JCR) announced on 29 September 2017 that it had applied for Japanese regulatory approval for its agalsidase beta biosimilar (JR‑051).

Integrating biosimilars into clinical practice

Biosimilars/Research | Posted 06/10/2017

According to authors from the National Advisory Unit on Rehabilitation in Rheumatology and the Rheumatology Department of Diakonhjemmet Hospital, Oslo, Norway, key questions when it comes to biosimilars include interchangeability, switching and automatic substitution [1].

FDA accepts application for Adello’s filgrastim biosimilar

Biosimilars/News | Posted 06/10/2017

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

Biosimilars/General | Posted 06/10/2017

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

Biosimilars/News | Posted 29/09/2017

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

Biosimilars/Research | Posted 29/09/2017

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

Biosimilars/News | Posted 29/09/2017

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

Biosimilars/Research | Posted 29/09/2017

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

Biosimilars/General | Posted 29/09/2017

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

Biosimilars/News | Posted 22/09/2017

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

Biosimilars/Research | Posted 22/09/2017

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

Biosimilars/Research | Posted 22/09/2017

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

Biosimilars/News | Posted 22/09/2017

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

Biosimilars/General | Posted 22/09/2017

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

Biosimilars/General | Posted 15/09/2017

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

Biosimilars/News | Posted 15/09/2017

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

Biosimilars/Research | Posted 15/09/2017

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

Biosimilars/Research | Posted 15/09/2017

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

Biosimilars/News | Posted 15/09/2017

Two different groups announced that their trastuzumab biosimilars had been successfully submitted to the US Food and Drug Adminstration (FDA) for review.

Strategies of players on the global biopharmaceutical market

Biosimilars/Research | Posted 08/09/2017

With many expensive and high-selling biologicals losing patent protection and other exclusivity rights, biosimilars of these molecules may now enter the market, resulting in a shift of market shares, revision of strategies of companies and attraction of new players to the biopharmaceutical market.

EC approval for three rituximab biosimilars

Biosimilars/News | Posted 08/09/2017

On 13 July 2017, three rituximab biosimilars, Blizima, Rituzena (previously Tuxella) and Ritemvia, received European Commission (EC) approval.

Boehringer Ingelheim starts phase III interchangeability trial for adalimumab biosimilar

Biosimilars/News | Posted 08/09/2017

Germany-based Boehringer Ingelheim Pharmaceuticals (Boehringer Ingelheim) announced on 27 July 2017 that the first patient had been enrolled into the phase III VOLTAIRE‑X interchangeability study of its adalimumab biosimilar (BI 695501). The company says the trial ‘is the first study in the US to investigate an interchangeability designation for an adalimumab biosimilar candidate’.

Biological drug evolution: improved awareness and pharmacovigilance required

Biosimilars/Research | Posted 08/09/2017

The safety profile of established biological drugs can alter over time following changes to manufacturing processes. However, healthcare professionals are often unaware of changes and there is a need for improved pharmacovigilance, according to a report published by researchers in Scotland, UK [1].

FDA approves adalimumab biosimilar Cyltezo

Biosimilars/News | Posted 01/09/2017

On 25 August 2017, the US Food and Drug Administration (FDA) approved its second biosimilar version of AbbVie’s Humira (adalimumab).

Australia’s TGA consults on naming of biologicals

Biosimilars/General | Posted 01/09/2017

Australia’s drug regulatory agency, the Therapeutic Goods Administration (TGA), announced on 28 July 2017 that it was opening a consultation on how to name biologicals.

Rituximab biosimilar CT-P10 could save Europe Euros 90 million in its first year

Biosimilars/Research | Posted 01/09/2017

A recent publication in Advances in Therapy suggests that introducing CT-P10, a biosimilar of the anti-CD20 monoclonal antibody rituximab, would generate significant savings for European healthcare systems [1]. CT-P10 is approved by the European Medicines Agency (EMA) for all indications held by reference rituximab, including rheumatoid arthritis and haematological cancers, such as non-Hodgkin’s lymphoma and chronic lymphocytic leukaemia. Although the therapeutic benefits of anti-CD20 therapy are well established, the cost of reference rituximab is thought to create barriers to patient access [2]. It is hoped that the introduction of more affordable biosimilars will help address this issue. Gulácsi L et al. therefore quantified the potential budgetary impact of introducing CT-P10 for the treatment of rheumatoid arthritis and CD20-positive cancers in 28 European countries [1].

Biological drug evolution: inadequate short-term clinical trials

Biosimilars/Research | Posted 01/09/2017

The safety profile of established biological drugs can alter over time following changes to manufacturing processes and short-term clinical trials fail to isolate adverse events, according to a report published by researchers in Scotland, UK [1].