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CHMP’s September 2023 meeting highlights
In its September 2023 meeting, the EMA’s human medicines committee (CHMP) recommended nine medicines for approval and the extension of therapeutic indications for 11 medicines.
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Biosimilars
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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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FDA grants first approval for multiple sclerosis biosimilar
Sandoz’s Tyruko (natalizumab-sztn) is now the first US Food and Drug Administration (FDA)-approved biosimilar to Tysabri (natalizumab) injection for relapsing forms of multiple sclerosis.
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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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Adalimumab biosimilars shaping market, research states
GlobalData has shared research on how the loss of exclusivity of AbbVie’s Humira (adalimumab) is shaping the biosimilars market.
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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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Pfizer and Samsung Biologics ink biosimilars manufacturing deal
Samsung Biologics has signed two long-term manufacturing agreements for Pfizer’s multiproduct biosimilar portfolio, worth $897 million.
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Sandoz to move headquarters to Basel, Switzerland
As Sandoz prepares to become standalone company, the generic and biosimilar firm has declared it will base itself in Basel, facilitating closer collaboration.
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European Commission approves haematology biosimilar
A marketing authorisation for a biosimilar to eculizumab has been granted by the European Commission for paroxysmal nocturnal haemoglobinuria.
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Five proposed biosimilars planned for development in Europe
The extended partnership agreement between Alvotech and Advanz Pharmaceutical includes a biosimilar candidate to Entyvio® (vedolizumab).
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AI-driven biosimilar manufacturing partnership announced
Artificial intelligence technology will drive manufacture of high-quality biosimilars at scale under a partnership between Sandoz and Just - Evotec Biologics.
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Sandoz to boost biosimilar development with manufacturing expansion
€25m funding is intended to unite a cutting-edge biotech lab and analytical expertise at Sandoz's German biosimilar manufacturing site.
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Microbial fermentation tech market to exceed $56.9b by 2033
Trends such as sustainability and technological advances like AI are helping to boost the microbial fermentation technology market, a report says.
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Eculizumab biosimilar gets positive CHMP opinion
Samsung Bioepis’ first haematology biosimilar, which references Soliris (eculizumab), has been recommended for approval by the CHMP.
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Sandoz to build biologics plant in Slovenia
To support increasing biosimilar demand, Sandoz’s expected investment of $400m will fund construction of a new biologics plant in Slovenia.
