Biosimilars
Selection of quality attributes and test methods in biosimilarity assessment
Biosimilar development starts with a detailed characterization of the quality profile of the chosen reference product, to establish targets for cell line and process development, according to author Vandekerckhove and colleagues [1]. This characterization requires a careful determination of the range of variability for all relevant product quality attributes of the reference product, as well as an understanding of their relative importance, to ensure appropriate focus on the most important attributes. Following process development, similarity of the biosimilar candidate with the reference product must be demonstrated in comprehensive analytical studies. This first step in the demonstration of biosimilarity provides the most sensitive measurement of differences; and is instrumental in deciding the direction of further product development. Meticulous design of the analytical similarity programme is therefore critical to the success of biosimilar development.
Adalimumab and trastuzumab biosimilars gain EC approval
A trastuzumab biosimilar from Pfizer and three adalimumab biosimilars from Sandoz have been approved by the European Commission (EC).
Increase in use of biosimilar rituximab for NHL treatment
Researchers from the UK and US reported on how the treatment approach for non-Hodgkin lymphoma (NHL) patients has changed since the first biosimilars of rituximab were approved in the European Union five (EU5: France, Germany, Italy, Spain, UK) [1].
Japan approves first darbepoetin alfa biosimilar
Japan-based Kyowa Hakko Kirin announced on 16 August 2018 that it had gained Japanese approval for its darbepoetin alfa biosimilar.
Extension of indications and manufacturing approval for biologicals in the US
Filgrastim biosimilar Granix (tbo-filgrastim) has been approved for extended indications and Samsung BioLogics has received approval to manufacture a monoclonal antibody drug product.
Comparison of biosimilar and originator bevacizumab in NSCLC
A study carried out by international researchers reported results from a comparative clinical study of PF‑06439535, a candidate bevacizumab biosimilar compared to originator bevacizumab, in patients with advanced non-squamous non-small cell lung cancer (NSCLC) [1].
FDA guidance sought on false and misleading information on biosimilars
Pharma giant Pfizer has asked the US Food and Drug Administration (FDA) to issue guidance ‘clarifying appropriate sponsor communications about the nature and properties of biosimilars’.
Trastuzumab and Bevacizumab products approved in Australia and Argentina
Australia has approved a trastuzumab biosimilar and Argentina has approved a bevacizumab medicamento biológico similar.
Pooled analysis results of adalimumab, etanercept and infliximab biosimilars
South Korean electronics giant Samsung and biotechnology company Biogen Idec (Biogen) joint venture Samsung Bioepis, along with Biogen, announced on 13 June 2018 results of a pooled analysis combining data from three phase III trials that compared the efficacy and safety of anti-tumour necrosis factor (anti-TNF) biosimilars to their reference biologicals.
Comparison of trial and real-world data for biosimilar filgrastim
A study carried out by researchers from Germany compared results from a randomized controlled trial (RCT) of Sandoz’s biosimilar filgrastim and post-approval data on the safety of the biosimilar [1].
