Biosimilars/Research
Screening protein surface biosimilarity of rituximab using aptamers
Among the many features needed to prove sufficient biosimilarity to a licensed drug produced in living organisms, is coherency of the three-dimensional structure. The integrity thereof is vital for the efficacy and safety of a biopharmaceutical, and even small and local structural changes may result in loss of function or cause undesired side effects for the patients. Reliable assessment of the detailed three-dimensional structure, however, requires laborious analytical methods like Nuclear Magnetic Resonance (NMR) or X-ray crystallography. Another option, epitope characterization using antibodies specific for the target biologicals, is restricted by the availability of appropriate, well-characterized antibody panels and typically involves animal experiments.
More positive phase III results for rituximab biosimilar ABP 798
Biotech giant Amgen, and its partner Allergan, announced on 22 August 2019 positive data from a ‘top-line’ phase III study of its rituximab biosimilar (ABP 798) compared to Rituxan (rituximab) in non-Hodgkin's lymphoma (NHL) patients.
Clinical comparability between rituximab biosimilar RTXM83 and rituximab in diffuse large B-cell lymphoma patients
The arrival of biosimilars represents more affordable alternatives for patients in several countries, increasing their access to costly biological treatments [1]. The positive impact of biosimilars on the financial sustainability of healthcare systems has been recognized by several haemato-oncological societies.
Switching from reference to biosimilar infliximab in ankylosing spondylitis patients
Ankylosing spondylitis (AS) is a chronic inflammatory rheumatic disease that affects the spine and the sacroiliac (SI) joints. AS is a type of seronegative spondyloarthropathy [meaning that tests show no presence of rheumatoid factor (RF) antibodies] or axial spondyloarthritis (SpA), i.e. it is a chronic, autoinflammatory disease predominantly affecting the axial skeleton [1].
Perceptions of biosimilars among US cancer patients
Amid increasingly expensive cancer treatments, researchers in the US explored perceptions of generic drugs among a group of 75 patients, in findings presented alongside the 2019 American Society of Clinical Oncology (ASCO) Annual Meeting.
Comparison of darbepoetin alfa and epoetin alfa for the treatment of renal anaemia
Darbepoetin alfa (DA-α) manufactured by Hetero Biopharma (Hetero) is the first long-acting erythropoiesis-stimulating agent with extended dosing intervals. This gives it an advantage over epoetin alfa (EPO) and epoetin beta. It also has a half-life three-fold longer than that of EPO.
Safety of SC form of infliximab biosimilar CT-P13
Positive results for Celltrion Healthcare’s (Celltrion) subcutaneous (SC) formulation of its infliximab biosimilar, CT-P13 (Remsima), have been presented at the European Congress of Rheumatology 2019 (EULAR 2019) [1].
Positive phase III results for bevacizumab copy biological IBI305
Innovent Biologics (Innovent) has presented positive phase III results for its bevacizumab copy biological IBI305 at the 55th Annual Meeting of the American Society of Clinical Oncology (ASCO).
Extensive characterization of biosimilars: a pegylated filgrastim study
Pegfilgrastim, is a 38 kDa, pegylated form of filgrastim, with a 20 kDa monomethoxypolyethylene glycol (mPEG) molecule covalently bound to the N-terminal methionyl residue of filgrastim developed by Amgen. Attachment of the mPEG-moiety enables a longer half-life, that enables only once-per-cycle administration for the management of chemotherapy-induced neutropenia. This results in a much simpler treatment regime for patients. The biosimilar version of pegfilgrastim developed by Intas Pharmaceuticals, and marketed by Accord Healthcare under the brand name Pelgraz, is one of the first pegfilgrastim biosimilars to be approved for market authorization in the European Union (EU) [1].
Distinct suffixes will aid biosimilar competition, says new research
The differential naming of originator and biosimilar products supports accurate pharmacovigilance and promotes biosimilar uptake, finds a literature review recently published in GaBI Journal [1].
