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A spectrum of generics and biosimilars: research, reports, and interviews
A spectrum of generics and biosimilars: research, reports, and interviews
Home » Articles » Volume 14 / Year 2025 / Issue 2 » Editor's Letter » A spectrum of generics and biosimil...
Follow-on biologicals/biosimilars approved in Brazil: September 2025 update
Follow-on biologicals/biosimilars approved in Brazil: September 2025 update
Home » Articles » Volume 14 / Year 2025 / Issue 2 » Special Report » Follow-on biologicals/biosimilars ap...
Therapeutic equivalence of a formulation of purified micronized flavonoid fraction of diosmin/hesperidin 450 mg/50 mg in healthy adults: an open-label, randomized, single-dose, crossover study
Therapeutic equivalence of a formulation of purified micronized flavonoid fraction of diosmin/hesperidin 450 mg/50 mg in healthy adults: an open-label, randomized, single-dose, crossover study
Home » Articles » Volume 14 / Year 2025 / Issue 2 » Original Research » Therapeutic equivalence of a form...
Biosimilar trial failed? Investors get their money back: a new insurance model redefines clinical trial financing
Biosimilar trial failed? Investors get their money back: a new insurance model redefines clinical trial financing
Home » Articles » Volume 14 / Year 2025 / Issue 2 » Sponsored Article » Biosimilar trial failed? Investor...
Rising costs of biologicals: effective cost-containment does not please all stakeholders
Rising costs of biologicals: effective cost-containment does not please all stakeholders
Home » Articles » Volume 14 / Year 2025 / Issue 3 » Editorial » Rising costs of biologicals: effective co...
Biosimilars in oncology: beyond regulation—building confidence through evidence and dialogue
Biosimilars in oncology: beyond regulation—building confidence through evidence and dialogue
Home » Articles » Volume 14 / Year 2025 / Issue 3 » Editorial » Biosimilars in oncology: beyond regulatio...
Barriers to expanding biosimilars in oncological indications in Chile: A value-chain approach to understand visions and propose recommendations for improving value proposition
Barriers to expanding biosimilars in oncological indications in Chile: A value-chain approach to understand visions and propose recommendations for improving value proposition
Home » Articles » Volume 14 / Year 2025 / Issue 3 » Original Research » Barriers to expanding biosimilars...
Effective and safe handling of pre-filled syringe (PFS) for administration of biosimilar candidate AVT06 (aflibercept) in patients with chorioretinal vascular diseases
Effective and safe handling of pre-filled syringe (PFS) for administration of biosimilar candidate AVT06 (aflibercept) in patients with chorioretinal vascular diseases
Home » Articles » Volume 14 / Year 2025 / Issue 3 » Original Research » Effective and safe handling of pr...
Australian biosimilar policies not delivering on intended outcomes: where to from here?
Australian biosimilar policies not delivering on intended outcomes: where to from here?
Home » Articles » Volume 14 / Year 2025 / Issue 3 » Original Research » Australian biosimilar policies no...
A bioequivalence study of paliperidone palmitate once-monthly (156 mg/mL) extended-release injectable in patients with schizophrenia 
A bioequivalence study of paliperidone palmitate once-monthly (156 mg/mL) extended-release injectable in patients with schizophrenia 
Home » Articles » A bioequivalence study of paliperidone palmitate once-monthly (156 mg/mL) extended-rele...
Biosimilars: still safe, still effective, still not generics. Why is FDA suddenly pretending they are?
Biosimilars: still safe, still effective, still not generics. Why is FDA suddenly pretending they are?
Home » Articles » Biosimilars: still safe, still effective, still not generics. Why is FDA suddenly prete...
Physicochemical stability of Carboplatin Accord in punctured original vials, syringes and after dilution with 0.9% sodium chloride or 5% glucose solution
Physicochemical stability of Carboplatin Accord in punctured original vials, syringes and after dilution with 0.9% sodium chloride or 5% glucose solution
Home » Articles » Volume 13 / Year 2024 / Issue 2 » Special Report » Physicochemical stability of Carbopl...
Physicochemical stability of Cabazitaxel Accord in punctured original vials and after dilution with 0.9% sodium chloride or 5% glucose solution in non-PVC bottles
Physicochemical stability of Cabazitaxel Accord in punctured original vials and after dilution with 0.9% sodium chloride or 5% glucose solution in non-PVC bottles
Home » Articles » Volume 13 / Year 2024 / Issue 2 » Special Report » Physicochemical stability of Cabazit...
Physicochemical stability of Bortezomib Accord 2.5 mg/mL and diluted 1 mg/mL intravenous injection solution in punctured original vials and polypropylene syringes
Physicochemical stability of Bortezomib Accord 2.5 mg/mL and diluted 1 mg/mL intravenous injection solution in punctured original vials and polypropylene syringes
Home » Articles » Volume 13 / Year 2024 / Issue 2 » Special Report » Physicochemical stability of Bortezo...
Physicochemical stability of Azacitidine Accord 25 mg/mL suspension for injection in original vials and polypropylene syringes after reconstitution with refrigerated water for injection
Physicochemical stability of Azacitidine Accord 25 mg/mL suspension for injection in original vials and polypropylene syringes after reconstitution with refrigerated water for injection
Home » Articles » Volume 13 / Year 2024 / Issue 2 » Special Report » Physicochemical stability of Azaciti...
Transforming health care: CinnaGen’s leadership in follow-on biologicals/biosimilars development and market expansion
Transforming health care: CinnaGen’s leadership in follow-on biologicals/biosimilars development and market expansion
Home » Articles » Volume 13 / Year 2024 / Issue 3 » Interview » Transforming health care: CinnaGen’s lead...
A review of international initiatives on pharmaceutical regulatory reliance and recognition
A review of international initiatives on pharmaceutical regulatory reliance and recognition
Home » Articles » Volume 13 / Year 2024 / Issue 3 » Review Article » A review of international initiative...
Comment on the article by Reilly MS and McKibbin RD
Home » Articles » Comment on the article by Reilly MS and McKibbin RD ...
Comment on the article ‘Misinformation about interchangeable biosimilars’
Home » Articles » Comment on the article ‘Misinformation about interchangeable biosimilars’ ...
Third and final issue of GaBI Journal’s 13th volume
Home » Articles » Volume 13 / Year 2024 / Issue 3 » Editor's Letter » Third and final issue of GaBI Journ...
Biosimilar Red Tape Elimination Act (S.2305): weakening FDA regulatory standards for biosimilars, undermining physician confidence and jeopardizing patient health
Biosimilar Red Tape Elimination Act (S.2305): weakening FDA regulatory standards for biosimilars, undermining physician confidence and jeopardizing patient health
Home » Articles » Biosimilar Red Tape Elimination Act (S.2305): weakening FDA regulatory standards for bi...
Current trends in biosimilar uptake and special focus on automatic substitution – a symposium report
Current trends in biosimilar uptake and special focus on automatic substitution – a symposium report
Home » Articles » Current trends in biosimilar uptake and special focus on automatic substitution – a sym...
Turkey’s biotech manufacturing ambitions: Yerlika Biopharma’s strategic role
Turkey’s biotech manufacturing ambitions: Yerlika Biopharma’s strategic role
Home » Articles » Turkey’s biotech manufacturing ambitions: Yerlika Biopharma’s strategic role ...
Trends in Saudi FDA drug approvals and GMP inspections: an observational study
Author byline as per print journal: Dr Ali M Alhomaidan; Mohammed Abdulaziz Alageel; Turki Abdulaziz Alrafie; Hassan Moham...
The incorporation of the Halal Management System (HMS) by the pharmaceutical industry
Author byline as per print journal: Ka-Liong Tan1, DPhil; Ainoon Othman1; Irwan Mohd Subri3; Noor Fadzilah Zulkifli1; Mohd...
Biosimilar antibody drug conjugates: considerations of higher order structure and aggregation
Abstract: Undoubtedly the complexity of Antibody Drug Conjugate (ADC) molecules where three components (monoclonal antibod...
Medicare drug price negotiations: impact on healthcare development and patient access to medicines
Author byline as per print journal: Michael S Reilly, Esq; Thomas R Barker, Esq, JD; Charles M Clapton, Steven J Potts, Ph...
Extrapolation requires reading between the lines
The articles in this second issue of 2023 include an Original Research study (Internet questionnaire) of the ‘opinions’ of...
Follow-on biologicals/biosimilars approved in Brazil: May 2023 update
Abstract: Brazilian requirements for approval of biosimilars are aligned with a strict regulatory process and ensure the s...
Ethnic sensitivity assessments in biosimilar monoclonal antibodies clinical development programmes: necessary or not?
Author byline as per print journal: Sandeep N Athalye1, MBBS, MD; Dev B Baruah1, MPharm; Shivani Mittra1, MPharm, PhD; Ank...
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