The advent of biological medicines has significantly transformed the landscapes of many disease spaces and improved the lives of millions around the world. However, the structural complexity and sensitivity of such products result in a high price tag, adding to already financially strained healthcare systems. As these and other expensive complex drugs lose market exclusivity, stakeholders eagerly await the arrival of lower cost alternatives, such as biosimilars and follow-on non-biological complex drugs (NBCDs). Nevertheless, stakeholders remain uncertain about key issues which have resulted in heterogeneous reimbursement policies and varying levels of biosimilar uptake and differences in the approval processes for follow-on NBCDs between different markets.
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Generics
News
- 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
News
- 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
- 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
- Biosimilars and other copies of biological products
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