Biosimilars
Clinical trials begin for ustekinumab biosimilars
Biosimilars firms BioFactura and Alvotech announce the start of clinical trials for their Stelara (ustekinumab) biosimilars, named BFI-751 and AVT04, respectively.
Biosimilars as a sustainable alternative for complex diseases
The use of ‘similar biotherapeutic’ products and ‘biocomparable’ medicines, as biosimilar medicines are named in Colombia and Mexico, respectively, offer a sustainable alternative for health systems, leading to significant savings for payers and health institutions, as well as market opening. Biosimilars thus provide a fair competitive solution.
EMA recommends approval of Samsung Bioepis/Biogen’s ranibizumab biosimilar Byooviz
The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has given a positive opinion for the ranibizumab biosimilar Byooviz (SB11), produced by Samsung Bioepis and commercialized by Biogen.
Switching to biosimilars safe and effective in IBD patients
Multiple adalimumab biosimilars are now approved for use in inflammatory bowel disease (IBD). In fact, to date, 29 June 2021, there are 10 adalimumab biosimilars approved in Europe [1]. However, despite their approval, effectiveness and safety data in IBD remains scarce, according to authors from the UK and The Netherlands [2].
PANLAR issues consensus statement on biosimilars
PANLAR presented its position on biosimilar medicines at its own congress in Argentina. Via the consensus statement, the PANLAR specialists seek to demonstrate the efficacy, pharmacovigilance, regulation, quality and safety of biosimilar medicines.
Biosimilars in Spain: balance between innovation and health public expenditure
Biosimilars have been marketed in the European Union (EU) for 13 years. Due to uncertainties about substitutability and interchangeability, their commercialization has been criticised.
Biosimilars in Japan: an overview
No regulations on interchangeability exist in Japan and switching between a reference product and biosimilar is often impractical, according to a letter recently published in The Lancet Oncology [1].
Canada approves rituximab biosimilar Riabni
Canada’s drug regulator, Health Canada, has approved the rituximab biosimilar Riabni for the treatment of rheumatoid arthritis as well as chronic lymphocytic leukaemia and non-Hodgkin’s lymphoma.
Regulatory landscape for similar biotherapeutic products in Latin America
Most Latin American countries are in the process of or have already established their own regulatory guidelines for similar biotherapeutic products (SBPs), and there are regional recommendations on how to ensure the safety and efficacy of biosimilars.
Biosimilar pipelines for South Korean firms: LG Chem and GC Pharma
Biosimilar makers from South Korea are making their mark, not only in South Korea, but around the world when it comes to biosimilars. Celltrion Healthcare (Celltrion) and Samsung Bioepis (Samsung and Biogen’s joint venture) are already becoming major players in the world of biosimilars. While, other Korean companies, such as LG Chem Life Sciences (LG Chem) and GC Pharma (formerly Green Cross) are also expanding their biosimilar pipelines.
