The US Food and Drug Administration (FDA) announced in February 2020 that it had issued draft guidance on getting approval for biosimilars for just some of the approved indications of the originator biological.
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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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