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
- 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
- Cancer and diabetes generic treatments receive positive opinion from EMA’s CHMP
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Biosimilars
News
- FDA approves pegfilgrastim and rituximab biosimilars
- Byooviz: first ophthalmology biosimilar launches in US
- Biocon: cancer biosimilar launch in Canada and US$90 million Malaysia deal
- Canada approves five biosimilars in last seven months
Research
- No trends in biosimilars uptake levels in the US, reveals study
- The impact of biosimilar insulins on public spending in Brazil
- Challenges with implementing benefit-sharing programmes for biologicals in Europe
- Successful increase of biosimilar adoption in a large integrated health delivery network
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