In preparation for the UK’s withdrawal from the European Union (EU), set to take place on 29 March 2019, the European Medicines Agency (EMA) and the European Commission have issued regulatory guidance to pharmaceutical companies. The EU wants to ensure that pharmaceutical companies plan for Brexit to avoid any impact on the continuous supply of medicines within the EU.
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Generics
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- US generics launch and approval for Dr Reddy’s and Lupin
- Five Chinese companies join UN’s MPP for Covid-19 medicines
- South Korean companies to make generic Bridion and COVID-19 drugs
- Revlimid (lenalidomide) generics launch across Europe
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Biosimilars
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- EMA recommends approval of eculizumab biosimilar Epysqli
- New indication for Cosentyx (secukinumab) biological: hidradenitis suppurativa
- Advances for STADA-Xbrane’s Ximluci in Europe, the UK and the US
- Rinvoq approved to treat Crohn’s disease in Europe
Research
- Low switch-back for patients treated with Avsola for IBD
- High mannose glycans in biosimilars and their pharmacokinetic impact
- Biosimilars in Southern European Hospital Markets: barriers and determinants of uptake
- Using infliximab economic evaluations in IBD to inform biosimilar access policies
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