Biological drugs should be subject to generic competition in the US after seven years, the Obama administration said, calling it a ‘generous compromise’. Brand-name companies have lobbied for 12 to 14 years of exclusivity, while Mr Waxman proposed only five. As reported by Bloomberg News, access to cheaper copies of medicines made by biotechnology companies is ‘a key element’ in reducing healthcare costs, White House officials said in a letter to Representative Henry Waxman. “Lengthy periods of exclusivity will harm patients by diminishing innovation and unnecessarily delaying access to affordable drugs,” it said.
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Generics
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- FDA approves generic teriparatide and levetiracetam
- 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
Research
- Japan’s drug shortage crisis: challenges and policy solutions
- Saudi FDA drug approvals and GMP inspections: trend analysis
- Generic medications in the Lebanese community: understanding and public perception
- Community pharmacists’ understanding of generic and biosimilar drugs: Lebanon case study
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Biosimilars
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- Canada approves first tocilizumab biosimilar Tyenne
- EMA recommends approval for ustekinumab biosimilar Absimky and Imuldosa
- Canada approves pegfilgrastim biosimilar Armlupeg
- FDA approves fifth ustekinumab biosimilar Imuldosa
Research
- Pertuzumab biosimilar HLX11 meets primary endpoint in Phase 3 comparative clinical study
- Uzpruvo/AVT04 biosimilar in profile
- Long-term real-world safety experience of biosimilars confirms concept of biosimilarity
- Budget impact analysis of Rixathon introduction in Chile for non-Hodgkin lymphoma
General
- Biologicals and biosimilars available for IBD in Canada
- Biosimilar medicines on the Pharmaceutical Benefits Scheme in Australia
- SBR issues consensus on interchangeability of reference products and biosimilars
- Innovative direct purchase agreement sees adalimumab biosimilar prices slashed
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