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European Commission grants first-of-a-kind biosimilar approval
The approval means Sandoz’s Wyost® and Jubbonti® are the first biosimilars of denosumab authorised in Europe.
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Injectable drug delivery market to value $1139.4b by 2029
Key drivers of the global injectable drug market include technological advancement and an increase in chronic diseases such as cancer, due to treatments utilising this drug delivery method.
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European Commission authorises one of first ustekinumab biosimilars in Europe
This approval follows a development and commercialisation agreement made in September 2023 between Sandoz and Samsung Bioepis for the biosimilar ustekinumab.
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Sandoz granted novel biosimilars approval
The approval authorises the interchangeability of denosumab biosimilars in the US to treat primary and secondary bone loss.
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Construction starts on $400m biosimilars production centre in Slovenia
Lek Pharmaceuticals, part of Sandoz, has started building a $400 million biologics manufacturing centre in Slovenia.
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Sandoz mobilises critical medicine production in Europe
Alongside its new biosimilar facility, Sandoz’s new penicillin production process will help secure European-based antibiotic supply.
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Sandoz and Teva achieve first-of-a-kind manufacturing certification
In their commitment to tackling global antimicrobial resistance (AMR), the first two Pharma companies have gained independent certification in responsible antibiotic manufacturing.
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European Pharmaceutical Review Issue 5 2023
EPR Issue 5 includes articles on microbiological testing of ATMPs, the use of inline Raman spectroscopy for bioprocess control, paediatric drug formulation, and more.
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Novartis completes Sandoz spin-off
As a newly independent company, Sandoz will concentrate on developing generic and biosimilar medicines, while its former parent company Novartis plans to drive its business forward with a strategic focus on innovative medicines.
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First multiple sclerosis biosimilar approved in Europe
Sandoz’s monoclonal antibody Tyruko® has been approved for all indications of reference medicine, as the first biosimilar to treat relapsing forms of multiple sclerosis (MS) in Europe.
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Sandoz to commercialise mAb biosimilar candidate
A new commercialisation agreement between Sandoz and Samsung Bioepis’ for its ustekinumab biosimilar candidate, means Sandoz now has five potential high-value biosimilars anticipated to launch over the next two years.
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Curbing AMR through sustainable antibiotic manufacturing
Key recommendations highlighted in a recent report by the Access to Medicine Foundation offer pharmaceutical manufacturers ways to effectively manage the release of antibiotic waste into the environment, and thus contribute to the reduction of antimicrobial resistance (AMR).
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Sandoz to file for approval of aflibercept biosimilar
Sandoz intends to seek regulatory approval for its aflibercept biosimilar in the US and EU in the coming months.
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Sandoz to build Slovenian biosimilar development facility
A planned investment of approximately $90 million will help build Sandoz’s new Slovenia-based biopharma biosimilar development facility by 2026.
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New AMR certification launched for antibiotic manufacturers
Following publication of the Antibiotic Manufacturing Standard in 2022 to help overcome AMR, antibiotic manufacturers can now verify their actions through a new certification.
