Following the expiration of patents on the originator molecules, copied products have been introduced into the market. EU regulators have named these products as ‘biosimilars’, that is ‘similar biological medicinal products’; and US regulators refer to them as ‘follow-on biologics’. Specific regulatory pathways have also been established for these biosimilar products, which differ from those for ‘chemical generics’ [1].
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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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