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
Research
- Evaluation of pharmaceutical equivalency of manufactured generic drugs in UAE
- New insights into the amount of R & D for new uses of generic drugs
- Pricing and reimbursement of medicines in Canada
- Medicines pricing conditions in Italy and Brazil: comparison of regulations
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Biosimilars
News
- China approves tocilizumab copy biological BAT1806
- FDA accepts application for denosumab biosimilar GP2411
- EMA accepts application for ustekinumab biosimilar AVT04
- Ranibizumab biosimilar Ximluci and Amelivu to launch in the UK and South Korea
Research
- A global overview of manufacturers of follow-on biologicals
- Study supports increased development of insulin biosimilars
- Malaysian hospital pharmacists’ perspective on and role in promoting biosimilars use
- Survey demonstrates US pharmacist biosimilar knowledge gaps
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