Biosimilars/General
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.
Joint statement on biosimilars in immune-mediated diseases in Spain
A study conducted and published by Monte-Boquet E et al. aimed to improve knowledge and use of biosimilar medicines in immune-mediated diseases, and to produce a unified framework for the use of biosimilars [1].
An update on the joint EMA-HMA statement on interchangeability of biosimilar
On 21 April 2023, the European Medicines Agency (EMA) and the Heads of Medicines Agencies (HMA) issued an updated joint statement on the interchangeability of biosimilars approved in the EU.
Biosimilars switching policies for Canada’s Newfoundland and Labrador, and Yukon
The Canadian provinces of Newfoundland and Labrador, and Yukon, become the 9th and 10th Canadian provinces to announce that they are adopting biosimilars switching policies.
Advancing biosimilar drug development with pharmacodynamic biomarkers
US Food and Drug Administration (FDA) researchers are studying the use of pharmacodynamic (PD) biomarkers to demonstrate biosimilarity. These studies could make the process of developing biosimilars more efficient and faster.
