Biosimilars
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.
Mylan launches adalimumab biosimilar Hulio in Spain
US-based drugmaker Mylan announced on 9 July 2019 the launch of its adalimumab biosimilar, Hulio, in Spain; the company’s first biosimilar in the country.
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.
Heparin biosimilar to be marketed in Canada
Canadian pharmaceuticals firm Valeo Pharma Inc has been given the rights to market a biosimilar version of low molecular weight heparin (LMWH), which is used to prevent blood clots in a range of conditions.
Momenta drops Humira biosimilar development
Momenta Pharmaceuticals Inc announced its financial results for the second quarter of 2019 on 2 August 2019. In this, they reported that they will stop the development of their Humira (adalimumab). However, they will continue to develop other biosimilar products.
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.
Trastuzumab biosimilar to be distributed by Mundipharma
Singapore-based Prestige BioPharma’s (Prestige) trastuzumab biosimilar Tuznue (HD201) will be distributed in selected European markets exclusively by UK-based Mundipharma International (Mundipharma) and its independent associated companies. Tuznue is a biosimilar of Roche’s Herceptin (trastuzumab) which is used to treat patients with human epidermal growth factor receptor 2 (HER2)-overexpressing breast cancer, HER2-overexpressing metastatic gastric cancer or gastroesophageal junction adenocarcinoma.
Mylan launches first trastuzumab biosimilar in Australia
Global generics firm Mylan NV (Mylan) and collaborating Indian pharmaceuticals giant Biocon Ltd (Biocon) have announced the launch of the first trastuzumab biosimilar in Australia. The drug can be used to treat breast and stomach cancers and will be marketed as Ogivri.
