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).