A European Commission (EC) report on the monitoring of patent settlements has found that the number of patent settlements in the pharmaceutical sector that are ‘potentially problematic’ under the EU’s antitrust rules fell to 10% of total patent settlements in the sector in the period July 2008 to December 2009 compared with 22% in the period covered in last year's inquiry (January 2000–June 2008).
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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
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Biosimilars
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- Ustekinumab biosimilars Yesintek, Steqeyma, and Otulfi approved by FDA, EMA and Health Canada
- EMA recommends approval for four denosumab biosimilars: Obodence, Osenvelt, Stoboclo, Xbryk
- EMA recommends approval of three aflibercept biosimilars: Ahzantive, Baiama, and Eydenzelt
- Canada approves first tocilizumab biosimilar Tyenne
Research
- Are interchangeable biosimilars at risk?
- Comparative efficacy studies: where are we now?
- Pertuzumab biosimilar HLX11 meets primary endpoint in phase III comparative clinical study
- Uzpruvo/AVT04 biosimilar in profile
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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