Biosimilars/General
Biosimilars of omalizumab
Last update: 3 November 2017
Omalizumab is a recombinant DNA-derived humanized IgG1k monoclonal antibody that specifically binds to free human immunoglobulin E (IgE) in the blood and interstitial fluid and to membrane-bound form of IgE (mIgE) on the surface of mIgE-expressing B lymphocytes [1]. Unlike an ordinary anti-IgE antibody, it does not bind to IgE that is already bound by the high affinity IgE receptor (FcεRI) on the surface of mast cells, basophils, and antigen-presenting dendritic cells.
Biosimilars of adalimumab
Last update: 11 March 2024
Adalimumab is a human monoclonal antibody that treats autoimmune diseases by inhibiting tumour necrosis factor (TNF); a soluble inflammatory cytokine. Adalimumab binds to TNF-alpha (TNF-α), preventing it from activating TNF receptors, which cause the inflammatory reactions associated with autoimmune diseases. Adalimumab is indicated for the treatment of rheumatoid, juvenile idiopathic and psoriatic arthritis, ankylosing spondylitis, Crohn’s disease, psoriasis and ulcerative colitis.
ASCO policy statement on biosimilars and interchangeables in oncology updated
The American Society of Clinical Oncology (ASCO) has released a new policy statement on the use of biosimilar and interchangeable products in oncology.
The statement proposes guidance and recommendations for stakeholders, including manufacturers, payers, regulatory agencies, clinicians, and patients, to ensure equitable access to high-quality care and to address challenges to biosimilar uptake [1].
Biosimilars approved in Japan
Last update: 24 October 2023
In Japan, the regulatory body for the approval of medicines, including biologicals, is the Ministry for Health Labour and Welfare (MHLW).
Promotion of biosimilar product development in Puerto Rico
The Puerto Rico Economic Development Bank (Banco de Desarrollo Económico para Puerto Rico, BDE)announced in August 2023 a funding of US$3.85 million for Biosimilar Sciences PR, LLC (Biosimilar Sciences) and Ocyon Bio PR Inc (OcyonBio) to facilitate the purchase of specialized biotechnology equipment. This funding comes from the State Small Business Credit Initiative (SSBCI) of the US Treasury for Small Businesses.
CVS’ Cordavis to launch Sandoz’s Hyrimoz (adalimumab)
In August 2023, CVS Health Corp announced it has launched a new company called Cordavis that will work directly with manufacturers to commercialize and co-produce biosimilar medicines for the US market.
Coherus retracts AbbVie restraining order in Humira biosimilar dispute
Coherus BioSciences agreed to retract its restraining order against AbbVie in June 2023, an action taken to prevent AbbVie from terminating its Humira licence deal [1].
Proposal to widen access to trastuzumab in New Zealand
In New Zealand there has been a proposal to widen access to intravenous trastuzumab from Herceptin to a biosimilar trastuzumab called Herzuma from 1 December 2023.
GADECCU position statement on biosimilars updated
GADECCU (Grupo Argentino de Enfermedad de Crohn y Colitis Ulcerosa), the Argentine Group for Crohn's Disease and Ulcerative Colitis, after providing key definitions on medical switch, non-medical switch and automatic substitution [1] and considering all the scientific information available, has updated its position in March 2023 regarding the use of biological medicines in clinical practice.
GADECCU presents a new positioning on biosimilars
The Argentine Group for Crohn's Disease and Ulcerative Colitis (Grupo Argentino de Enfermedad de Crohn y Colitis Ulcerosa, GADECCU) has released an updated position statement on biosimilars, particularly regarding the alternate use of innovative biological drugs and biosimilars during the same chronic treatment in patients with inflammatory bowel disease.
