Despite the fact that a legal pathway for the approval of biosimilars in the US has existed for more than a year, formal guidance has still not been issued by FDA. This has led many to question when, or even if, biosimilars will come onto the market in the US . So what has FDA been doing in the meantime and how close are we to seeing some biosimilar guidance in the US?
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- 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
- Relevance of NTI to the treatment of epilepsy
- What is the meaning of a narrow therapeutic index?
- Consequences of generics being favoured by healthcare providers
- What is meant by a generic medication and generic equivalence?
- EMA recommends approval of bevacizumab biosimilar Vegzelma
- FDA approves pegfilgrastim and rituximab biosimilars
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- Biocon: cancer biosimilar launch in Canada and US$90 million Malaysia deal
- Adalimumab biosimilar MSB11022: PK and tolerability of autoinjector versus pre-filled syringe
- 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
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