The relevant European guideline states that if the reference medicinal product has more than one indication, the efficacy and safety of a biosimilar has to be justified, if necessary by demonstrating it separately for each indication claimed. The guideline brings up the possibility of ‘extrapolating’ efficacy (granting several clinical indications that are licensed for the reference product, although only one of the indications has been studied in the clinical development programme of the biosimilar). This would not be done without serious consideration. The mechanism of action of monoclonal antibodies (mAbs) is usually complex and in many cases only partially understood.
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Generics
News
- 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
News
- EMA recommends approval for tocilizumab biosimilar Avtozma and filgrastim biosimilar Zefylti
- 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
Research
- Positive safety and efficacy primary endpoint results for AVT05 (golimumab proposed biosimilar)
- Are interchangeable biosimilars at risk?
- Comparative efficacy studies: where are we now?
- Pertuzumab biosimilar HLX11 meets primary endpoint in phase III comparative clinical study
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