news
Citrate-free HCF of adalimumab biosimilar gets positive opinion
A positive opinion has been adopted by the CHMP for a citrate-free high concentration formulation of its biosimilar Hyrimoz® (adalimumab).
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Biosimilars
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MHRA approves biosimilar for vision disorders in Great Britain
A marketing authorization for Ximluci® biosimilar referencing Lucentis® (ranibizumab) in Great Britain has been issued by the Medicines and Healthcare products Regulatory Agency (MHRA).
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Pharmapack Europe to launch two new zones in 2024
Two new zones will be launched at Pharmapack Europe in 2024, to support growing demand for biologics, mRNA therapeutics and contract packaging.
whitepaper
Whitepaper: Imaweld® heat sealable & weldable tube bioprocess media
Imaweld® is distinct due to its composition, which seals and welds tubes and highly endorsed in biopharma for cell membrane and cell culture applications
whitepaper
Whitepaper: Optimising the efficiency of QC laboratory: The power of automation
Charles River launches Endosafe Nexus 200, emphasises the importance of automated endotoxin testing systems to improve the efficiency of QC labs.
whitepaper
Whitepaper: Single-use technologies in biosimilar development
ImaLINK™ manifold, which is designed to minimise the need for fittings, connections or assembly of all leak points, entrapment areas are eliminated.
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Interchangeability of biosimilars in the EU – the industry impact
In a reversal of approach, EU medicines regulators have for the first time published a statement supporting the interchangeability of biosimilar medicines in the EU. Here, Marie Manley and Chris Boyle from Sidley Austin LLP explore what this could mean for biopharma companies.
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2022 WHO Biosimilar Guideline improves access, IGBA says
Under the revised 2022 WHO Biosimilars Guideline, IGBA says regulatory authorities can confidently revaluate biosimilar access requirements.
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US legislative update: takeaways for European pharma
Keith A Zullow and Jenny J Zhang from Goodwin Procter examine upcoming US pharmaceutical regulation and how, if passed, it could impact European pharma/biopharma looking to access the US market.
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Biosimilar competition saves US healthcare $21 billion
The US biosimilars market experienced dramatic growth in 2022, particularly for therapies helping to treat oncological and inflammatory conditions, Amgen suggested in a recent report.
video
On-demand webinar: Effective contamination control strategy
Discover the significance of accurate microbial identifications in building an effective contamination control strategy to keep up with the latest regulatory requirements.
news
EMA approves biosimilar interchangeability in EU
Biosimilar medicines can now be interchanged with their reference medicine or an equivalent biosimilar, says European Medicines Agency (EMA).
whitepaper
Whitepaper: Annual PQR: A thing of the past
Anytime PQR is the new way of generating APQR by automating the reports anytime in 3 easy steps. Now make the entire process system driven with CaliberAPQR.
![Sandoz company logo on office building in Warsaw city centre [Credit: Konektus Photo/Shutterstock.com].](https://www.europeanpharmaceuticalreview.com/wp-content/uploads/Sandoz-2-e1661424920546-300x278.jpg)
![Sandoz company logo on office building in Warsaw city centre [Credit: Konektus Photo/Shutterstock.com].](https://www.europeanpharmaceuticalreview.com/wp-content/uploads/Sandoz-2-e1661424920546.jpg)
news
Sandoz to become standalone company
A spin-off from parent company Novartis aims to set Sandoz up as the premier European generics company.
video
On-demand webinar: The advantages of cartridge technology
Why do pharmaceutical manufacturers still believe older methods are reliable for quality testing when there’s superior technology available on the market?
