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Citrate-free HCF of adalimumab biosimilar gets positive opinion

A positive opinion has been adopted by the CHMP for a citrate-free high concentration formulation of its biosimilar Hyrimoz® (adalimumab).

Florian bieberGlobal head biopharmaceuticals development at sandozEuropean medicines agencyDrug administrationCommittee for medicinal products human useMedicinal productsHuman useGlobal head biopharmaceuticals development

Sandoz Application for proposed biosimilar adalimumab s

Submission supported by comprehensive analytical and clinical data from new Phase I bridging pharmacokinetics studyAdalimumab’s high-concentration 100.

United statesRichard jarvisIsabella zinckThomas hungerbuehlerSandoz hyrimozSamir shahChris lewisSloan simpsonFlorian bieberNovartis communicationsAbbvie biotechnology ltdExchange commissionEuropean medicines agencySandoz global communicationsGlobal head biopharmaceuticals developmentEuropean commission

Investegate |NOVARTIS AG CHF0 50(REGD) Announcements | NOVARTIS AG CHF0 50(REGD): Sandoz Application for proposed biosimilar adalimumab s high concentration formulation accepted by EMA

Investegate announcements from NOVARTIS AG CHF0.50(REGD), Sandoz Application for proposed biosimilar adalimumab’s high concentration formulation accepted by EMA

United statesRichard jarvisIsabella zinckThomas hungerbuehlerSandoz hyrimozSamir shahChris lewisSloan simpsonFlorian bieberNovartis communicationsAbbvie biotechnology ltdExchange commissionEuropean medicines agencySandoz global communicationsGlobal head biopharmaceuticals developmentSandoz application

Novartis Pharma AG: Sandoz Application for proposed biosimilar adalimumab s high concentration formulation accepted by EMA

Submission supported by comprehensive analytical and clinical data from new Phase I bridging pharmacokinetics studyAdalimumab's high-concentration 100 mg/mL formulation aims to provide an enhanced yet

United statesRichard jarvisIsabella zinckThomas hungerbuehlerSandoz hyrimozSamir shahChris lewisSloan simpsonFlorian bieberNovartis communicationsAbbvie biotechnology ltdExchange commissionEuropean medicines agencySandoz global communicationsGlobal head biopharmaceuticals developmentEuropean commission

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