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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.
Under the revised 2022 WHO Biosimilars Guideline, IGBA says regulatory authorities can confidently revaluate biosimilar access requirements.
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.
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.
Discover the significance of accurate microbial identifications in building an effective contamination control strategy to keep up with the latest regulatory requirements.
Biosimilar medicines can now be interchanged with their reference medicine or an equivalent biosimilar, says European Medicines Agency (EMA).
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![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)
A spin-off from parent company Novartis aims to set Sandoz up as the premier European generics company.
Why do pharmaceutical manufacturers still believe older methods are reliable for quality testing when there’s superior technology available on the market?
Many quality control professionals recognise that the need to modernise microbial detection methods is at an all-time high.
Single use technologies is highly booming in biopharmaceutical sector due to its efficient use and benefits.
PCI’s Tim Roberts discusses key factors when outsourcing the clinical and commercial supply of biologics, and what makes a strong CDMO partnership.
Find out how a pharma company maintained product quality and reduced plate counts by 25 percent using a rapid microbial monitoring analyser – the 7000RMS.
Ambitions to reach greater numbers of patients with unmet need have fuelled some benevolent plans from bio/pharmaceutical companies ViiV Healthcare and Sandoz.
The importance of thoroughly planned resupply strategies in maintaining clinical supply inventories as studies move into late phase.
