Biosimilars
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.
Novo Nordisk petitions FDA to require clinical trials for Victoza biosimilars
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
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
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
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
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
On 12 September 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
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 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
Japan-based generics maker Nichi-Iko Pharmaceutical (Nichi-Iko) announced on 27 September 2017 that it had gained Japanese approval for its infliximab biosimilar.
