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Interchangeability of biosimilars in the EU – the industry impact

European Pharmaceutical Review

1 However, as most biosimilars are developed by means of a complex biotechnological process in living organisms, this inevitably leads to differences between the biosimilar and the reference product. Marie Manley leads Sidley’s Life Sciences team in London and is a distinguished thought leader and adviser on EU and UK regulatory law.

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Achieving scale up success under economic uncertainty

European Pharmaceutical Review

For both small biotechs and large pharma, economic uncertainty is rising, intensifying decision-making risks associated with early drug discovery efforts, clinical trials, quality and manufacturing process execution, and navigating the approval process. In 2001 and 2007, through 2009, the economy was hit hard.

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PROTAC development gains momentum, but clinical performance is poor

Pharmaceutical Technology

The first concept for a PROTAC was published in 2001, and recently these protein degraders have gained rapid momentum as a promising novel modality. This makes early R&D less risky, as many lead compounds are discontinued due to inadequate pharmacokinetic profiles and require excessively high dosages to be pharmaceutically active.