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Biosimilars/Research

ST002293

Biosimilars applications reviewed in the EU

Biosimilars/Research | Posted 04/10/2019

The European Union (EU) was the first to establish a legal framework for biosimilars back in 2003 [1]. Since the European Medicines Agency (EMA) approved its first biosimilars in 2006, the agency has issued new guidelines and updated its existing guidelines based on new evidence and rapid advances in analytical sciences [2].

Immunogenicity Lonza V18D06

Switching from originator to biosimilar epoetins appears to be effective and safe

Biosimilars/Research | Posted 04/10/2019

Switching between biological drugs during pharmacological treatment leads prescribers and patients to ask themselves the question: ‘Will it be safe?’. In particular, when switching from an originator to a biosimilar, the belief that this choice is shaped by economic reasons feeds suspicions and controversies.

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Switching from originator infliximab to CT-P13: real-world data with 24 months of follow up

Biosimilars/Research | Posted 27/09/2019

A prospective observational study with moderate-to-severe Crohn’s disease (CD) and ulcerative colitis (UC) patients switched from infliximab to CT-P13 treatment was carried out at Hospital Universitario Virgen Macarena, Seville, Spain, and reviewed up to 24 months. The primary endpoint was to analyse the loss of response to infliximab after switching. A loss of response was considered as the Harvey–Bradshaw (HB) index >4 for CD, partial Mayo score (PMS) >2 for UC, steroid use or surgery related to the activity of the disease and/or infliximab dose increase during the follow up.

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Screening protein surface biosimilarity of rituximab using aptamers

Biosimilars/Research | Posted 20/09/2019

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.

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More positive phase III results for rituximab biosimilar ABP 798

Biosimilars/Research | Posted 13/09/2019

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.

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Clinical comparability between rituximab biosimilar RTXM83 and rituximab in diffuse large B-cell lymphoma patients

Biosimilars/Research | Posted 13/09/2019

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 mAb Pfizer V18K30

Switching from reference to biosimilar infliximab in ankylosing spondylitis patients

Biosimilars/Research | Posted 06/09/2019

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].

MD002297

Perceptions of biosimilars among US cancer patients

Biosimilars/Research | Posted 30/08/2019

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.

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Comparison of darbepoetin alfa and epoetin alfa for the treatment of renal anaemia

Biosimilars/Research | Posted 30/08/2019

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.

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Safety of SC form of infliximab biosimilar CT-P13

Biosimilars/Research | Posted 23/08/2019

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].