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Comment on the article ‘Misinformation about interchangeable biosimilars’
Comment on the article ‘Misinformation about interchangeable biosimilars’
Home » Articles » Volume 14 / Year 2025 / Issue 1 » Letters to the Editor » Comment on the article ‘Misin...
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 » Volume 14 / Year 2025 / Issue 1 » Meeting Report » Biosimilar Red Tape Elimination Act ...
An analysis of policy impacts on the price developments of biological medicines after patent expiration
An analysis of policy impacts on the price developments of biological medicines after patent expiration
Home » Articles » Volume 14 / Year 2025 / Issue 1 » Original Research » An analysis of policy impacts on ...
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 ...
Editor’s introduction to the initial issue of the 14th volume of GaBI Journal
Editor’s introduction to the initial issue of the 14th volume of GaBI Journal
Home » Articles » Volume 14 / Year 2025 / Issue 1 » Editor's Letter » Editor’s introduction to the initia...
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...
Follow-on biologicals/biosimilars approved in Brazil: September 2025 update
Follow-on biologicals/biosimilars approved in Brazil: September 2025 update
Home » Articles » Follow-on biologicals/biosimilars approved in Brazil: September 2025 update ...
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 » Therapeutic equivalence of a formulation of purified micronized flavonoid fraction of d...
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 » Biosimilar trial failed? Investors get their money back: a new insurance model redefine...
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 » Rising costs of biologicals: effective cost-containment does not please all stakeholder...
Transforming healthcare: CinnaGen’s leadership in follow-on biologicals/biosimilars development and market expansion
Abstract: CinnaGen, the largest biopharmaceutical company in the MENA region, is a leader in developing follow-on biologic...
A review of international initiatives on pharmaceutical regulatory reliance and recognition
Abstract: In light of recent global health challenges, the need for regulatory reliance – where one regulatory authority a...
Comment on the article by Reilly MS and McKibbin RD
Abstract: Reilly and McKibbin oppose the update of FDA interchangeability guidance that does not require clinical switch s...
Comment on ‘Misinformation about interchangeable biosimilars’
Author byline as per print journal: Hillel P Cohen, PhD; Caridad Pontes, MD, PhD; Fernando de Mora, MBA, PhD Abstract: The...
Third and final issue of GaBI Journal’s 13th volume
This third issue of GaBI Journal is the last of the volume for this year and marks the end of the first year of me taking ...
Physicochemical stability of Etoposide Accord in punctured original vials and after dilution with 0.9% sodium chloride or 5% glucose solution
Author byline as per print journal: Irene Krämer, PhD; Frank Erdnuess, PhD; Judith Thiesen, PhD Study objectives: To deter...
Physicochemical stability of Doxorubicin Accord 2 mg/mL in punctured original vials and polypropylene syringes and after dilution with 0.9% sodium chloride or 5% glucose solution in polyethylene bottles
Author byline as per print journal: Irene Krämer, PhD; Frank Erdnuess, PhD; Judith Thiesen, PhD Study objectives: To deter...
Physicochemical stability of Epirubicin Accord 2 mg/mL in punctured original vials and polypropylene syringes and after dilution with 0.9% sodium chloride or 5% glucose solution in polyolefine bags
Author byline as per print journal: Irene Krämer, PhD; Frank Erdnuess, PhD; Judith Thiesen, PhD Study objectives: To deter...
Physicochemical stability of Docetaxel Accord 20 mg/mL concentrate diluted with 0.9% sodium chloride or 5% glucose solution in non-PVC bags
Author byline as per print journal: Irene Krämer, PhD; Frank Erdnuess, PhD; Judith Thiesen, PhD Study objectives: To deter...
Physicochemical stability of Cytarabine Accord in punctured original vials and after dilution with 0.9% sodium chloride solution in polyolefine bags
Author byline as per print journal: Irene Krämer, PhD; Frank Erdnuess, PhD; Judith Thiesen, PhD Study objectives: To deter...
Physicochemical stability of Cisplatin Accord in punctured original vials, syringes and after dilution with 0.9% sodium chloride solution
Author byline as per print journal: Irene Krämer, PhD; Frank Erdnuess, PhD; Judith Thiesen, PhD Study objectives: To deter...
Physicochemical stability of Carboplatin Accord in punctured original vials, syringes and after dilution with 0.9% sodium chloride or 5% glucose solution
Author byline as per print journal: Irene Krämer, PhD; Frank Erdnuess, PhD; Judith Thiesen, PhD Study objectives: To deter...
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
Author byline as per print journal: Irene Krämer, PhD; Frank Erdnuess, PhD; Judith Thiesen, PhD Study objectives: To deter...
Physicochemical stability of Bortezomib Accord 2.5 mg/mL and diluted 1 mg/mL intravenous injection solution in punctured original vials and polypropylene syringes
Author byline as per print journal: Irene Krämer, PhD; Frank Erdnuess, PhD; Judith Thiesen, PhD Abstract: This study asses...
Physicochemical stability of Azacitidine Accord 25 mg/mL suspension for injection in original vials and polypropylene syringes after reconstitution with refrigerated water for injection
Author byline as per print journal: Irene Krämer, PhD; Frank Erdnuess, PhD; Judith Thiesen, PhD Abstract: The physicochemi...
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...
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