Biosimilars
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.
Canadian IBD charity updates biosimilar position statement
On 5 September 2019, Crohn’s and Colitis Canada announced that it had updated its position statement on the use of biosimilars for inflammatory bowel disease (IBD). The updated position statement was published after the organization reviewed its position on biosimilars particularly related to non-medical switching policy.
Herzuma gains Japanese approval for three-week cycle method
South Korean biotechnology company Celltrion announced at the end of August 2019 that Japan's Ministry of Health, Labour and Welfare (MHLW) had approved a three-week cycle method for its trastuzumab biosimilar, Herzuma (CT P6), in the treatment of breast cancer.
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.
Revance Therapeutics focus on its own Botox biosimilar as work with Mylan is stalled
As Revance gives Mylan more time to decide whether to develop their joint Botox biosimilar, the firm is continuing to focus on its own Botox biosimilar, DAXI. It aims to launch the product in 2020.
Teriparatide biosimilar Terrosa launched in Europe
Hungary-based Gedeon Richter (Richter) announced on 20 August 2019 that it had launched its teriparatide biosimilar Terrosa in Europe immediately following the patent expiry of the reference product in August 2019.
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].
Court rules Amgen’s patents on Enbrel are valid, Sandoz to appeal
After the US District Court of New Jersey ruled in Amgen’s favour on the validity of its patents for arthritis treatment Enbrel, Sandoz says it will appeal the ruling, which prevents the launch of its biosimilar Erlezi.
Positive results for Bio-Thera’s arthritis copy biologicals
China-based Bio-Thera Pharmaceuticals have begun a phase I trial for its Simponi copy biological and obtained positive results from a phase III trial of its Humira copy biological.
