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New biosimilar pathways – key takeaways from the EMA’s draft reflection paper

European Pharmaceutical Review

The European Medicines Agency (EMA) has published a draft reflection paper that signals a potential evolution in the regulatory landscape for biosimilar development within the EU. 1,2 The reflection paper also highlights the limitations and diminishing value of CES in many biosimilar development programmes.

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Breaking through the forecasting fog – 3 trends that will impact critical medicine supply in 2023

pharmaphorum

The same goes for many commodities used in the production process for key medicines, from solvents through to packaging. About the author Richard Saynor was appointed CEO of Sandoz in 2019, a Novartis generics and biosimilars division. He previously held regional leadership roles at Sandoz between 2005 and 2010.

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