Since the existence of a legal pathway for biosimilars was made possible by the signing of the 2009 Biologics Price Competition and Innovation (BPCI) Act in 2010 by President Barack Obama, FDA has declared itself ‘open for business’ for biosimilars . But what is the thinking of FDA and what should we expect from any guidance on biosimilars?
- 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
- 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?
- The cost of developing drugs and use of generics
- 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
- No trends in biosimilars uptake levels in the US, reveals study
- El impacto de las insulinas biosimilares en el gasto público brasileño
- Challenges with implementing benefit-sharing programmes for biologicals in Europe
- Successful increase of biosimilar adoption in a large integrated health delivery network
- Estado actual de los biosimilares de anticuerpos monoclonales aprobados en América Latina
- Una visión general de los biosimilares de anticuerpos monoclonales en América Latina
- American Academy of Ophthalmology biosimilars position statement published
- US prescription drug expenditure projection report
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