Biosimilars
Bio-Thera and Samsung Bioepis start clinical trials for ustekinumab biosimilars
China’s Bio-Thera Solutions and South Korea’s Samsung Bioepis have begun phase III clinical trials for biosimilars to Janssen’s blockbuster anti-inflammatory drug Stelara (ustekinumab).
Argentinian gastroenterologist groups issued position statement on biosimilars use
Experts from the steering committees of the Argentinian Society of Gastroenterology (SAGE), the Argentinian Federation of Gastroenterology (FAGE) and the Argentinian Group of Crohn's Disease and Ulcerative Colitis (GADECCU) have issued a joint position regarding the practical conditions for the clinical use of biosimilars indicated for inflammatory bowel diseases (IBDs), by discussing the most notable aspects related to the definition of a biosimilar drug, bio-similarity, non-comparable biological drugs or ‘intended copies’, approval requirements, extrapolation of indications, interchangeability, automatic substitution, non-medical switching, nomenclature, clinical standards regarding safety and efficacy, implementation of an efficient and appropriate pharmacovigilance system and the potential economic impact on the healthcare system [1].
Canada approves adalimumab and bevacizumab biosimilars
Canada’s drug regulator, Health Canada, has approved the bevacizumab biosimilar Bambevi and the adalimumab biosimilar Abrilada (PF-06410293).
Research, development and public production of pharmaceuticals in Argentina
Under the current research and development model, the pharmaceutical industry has switched its focus towards the therapeutic areas that offer the greatest commercial benefit, which are often not aligned with public health needs. Consequently, it has ceased to be the great innovative industry that it had been during the last century.
Delayed biosimilars market entry costs US billions
Delayed adalimumab biosimilar entry to the US market is estimated to have cost Medicare over US$2.19 billion between 2016 and 2019, a study published in Clinical Pharmacology and Therapeutics has revealed.
Competition from biosimilars drives price reductions for biologicals in France
The US has experienced a policy debate as to whether competition from biosimilars is the best strategy for achieving price reductions for biologicals or, rather, whether direct price regulation after loss of patent exclusivity would be more effective. In order to investigate this issue, authors from the US and France combined quantitative and case study methods to examine in detail the interaction between market and administrative mechanisms to reduce biologicals’ prices in France. In their article they present comprehensive data on market shares and prices for three major biologicals and their 11 competing biosimilars between 2004 and 2020 [1].
Bioeq submits application for ranibizumab biosimilar to FDA
A ranibizumab biosimilar developed by Swiss biotechnology company Bioeq AG (Bioeq) has been successfully submitted to the US Food and Drug Administration (FDA) for review.
Potential biotech collaboration between India and Colombia
A letter of intent on cooperation in biotechnology has been signed between India and Colombia, which could include collaborations on vaccines, biosimilars, and medical devices.
Biosimilars approved in Paraguay
In Paraguay, the regulatory body responsible for the approval of biological drugs is the National Directorate for Sanitary Surveillance (Dirección Nacional de Vigilancia Sanitaria, DINAVISA).
Positive trial results for bevacizumab copies from Betta Pharmaceuticals and Biocad
The bevacizumab copy biological MIL60 (Betta Pharmaceuticals Ltd) and non-originator biological BCD-021 (Biocad) have demonstrated clinical equivalence for the treatment of non-squamous non-small cell lung cancer (NSCLC) in phase III trials.
