Biosimilars/Research
Biosimilar insulins – reducing the cost of diabetes
Will biosimilar insulins be cheaper is a question raised by authors Lutz Heinemann and Alan Carter and one that they say is a clear yes [1].
European perspective on biosimilars
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].
Anti-drug antibody assays for biosimilars and originator biologicals
Biosimilar drug development has brought new challenges to bioanalytical ligand-binding assays used to determine drug concentration, anti-drug antibodies and neutralizing antibodies.
Challenges and opportunities in producing biosimilars
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.
Bevacizumab improves survival in NSCLC patients
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.
Adalimumab biosimilar ABP 501 shows similar efficacy, safety and immunogenicity
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.
Barriers to access to biosimilars
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].
Integrating biosimilars into clinical practice
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].
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].
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].
