Current Regulatory Framework and Challenges for the Approval of Complex Generics in the US and the EU DOI Creative Commons

Sharvari Patil,

Sandeep Kumar,

Dasari Mallikarjuna Rao

et al.

Current Indian Science, Journal Year: 2023, Volume and Issue: 02

Published: Dec. 11, 2023

Abstract: The pharmaceutical industry is witnessing a growing demand for complex generic products, which are versions of drugs that possess formulations, delivery systems, or active ingredients. However, the approval process these products poses unique challenges compared to traditional generics. There no specific regulatory procedure available generics, unlike smallmolecule generics and biosimilars. This led controversial arguments in past about scientific evidence needed applications, lengthy processes. frameworks currently being used debatable unclear. Complexity molecular structure, mechanism action, route delivery, manufacturing makes proving bioequivalence equivalence difficult. need harmonization framework by agencies help manufacturers providing advice, defining submission requirements fastening process. : review begins discussing landscape surrounding various regions, including United States Europe. It examines guidelines set forth authorities ensure safety, efficacy, quality products. Additionally, explores differences terminology definitions classify across different jurisdictions. Furthermore, it delves into faced both companies evaluating approving These include establishing appropriate criteria, determining interchangeability with reference product, addressing patent exclusivity issues, ensuring consistent throughout product lifecycle. impact on market entry competition also discussed. highlights streamlining regulations worldwide. emphasizes importance clear enable timely approvals, foster innovation, facilitate patient access affordable alternatives.

Language: Английский

Role of Modeling and Simulation in Preclinical and Clinical Long-Acting Injectable Drug Development DOI Creative Commons
Maxime Siemons, Bram Schroyen,

Nicolas Darville

et al.

The AAPS Journal, Journal Year: 2023, Volume and Issue: 25(6)

Published: Oct. 17, 2023

Abstract Innovations in the field of long-acting injectable drug development are increasingly being reported. More advanced vitro and vivo characterization can improve our understanding injection space aid describing (LAI) drug’s behavior at site more mechanistically. These innovations may enable unlocking potential employing a model-based framework LAI preclinical clinical space. This review provides brief overview process before delving deeper into current status modeling simulation approaches characterizing pharmacokinetics, focused on aqueous crystalline suspensions. A closer look is provided release methods, available biopharmaceutical models reported vitro/in correlations (IVIVCs) that advance development. The allows identifying opportunities for use model-informed gaps where further research be most warranted. Continued investment improving PK across species through translational facilitate future products. Graphical

Language: Английский

Citations

10
Understanding the In Vitro-In Vivo Nexus: Advanced correlation models predict clinical performance of liposomal doxorubicin DOI Creative Commons

Kennard Gan,

Zhuoxuan Li,

Phyo Maw Darli

et al.

International Journal of Pharmaceutics, Journal Year: 2024, Volume and Issue: 654, P. 123942 - 123942

Published: Feb. 24, 2024

In the century of precision medicine and predictive modeling, addressing quality-related issues in medical supply chain is critical, with 62 % disruptions being attributable to quality challenges. This study centers on development safety liposomal doxorubicin, where animal studies alone often do not adequately explain complex interplay between critical attributes vivo performances. Anchored our aim elucidate this vitro-in nexus, we compared TLD-1, a novel doxorubicin delivery system, against established formulations Doxil® Lipodox®. Robust correlations (IVIVCs) excellent coefficients determination (R

Language: Английский

Citations

4
Highly Efficient Organic Solvent-Free Oiling-Out-Dissolving Strategy to Fabricate Aripiprazole Microcrystals for Long-Acting Antipsychotics DOI
Lan Fang,

Luyan Wang,

Z. Ding

et al.

ACS Sustainable Chemistry & Engineering, Journal Year: 2025, Volume and Issue: unknown

Published: March 6, 2025

Language: Английский

Citations

0
Integrating Quantitative Methods & Modeling and Analytical Techniques in Reverse Engineering; A Cutting-Edge Strategy in Complex Generic Development DOI

Ashok Kumar Rajput,

Megha Pillai,

Jinal Ajabiya

et al.

AAPS PharmSciTech, Journal Year: 2025, Volume and Issue: 26(4)

Published: March 26, 2025

Language: Английский

Citations

0
Revisiting the in-vitro and in-vivo considerations for in-silico modelling of complex injectable drug products DOI

Amit Dabke,

Saikat Ghosh,

Pallavi Dabke

et al.

Journal of Controlled Release, Journal Year: 2023, Volume and Issue: 360, P. 185 - 211

Published: June 24, 2023

Language: Английский

Citations

6
A bio-predictive release assay for liposomal prednisolone phosphate DOI
Shakti Nagpal,

Jordan Png,

Lyes Kahouadji

et al.

Journal of Controlled Release, Journal Year: 2024, Volume and Issue: 374, P. 61 - 75

Published: Aug. 9, 2024

Language: Английский

Citations

2
In vitro-in vivo correlation (IVIVC) development for long-acting injectable drug products based on poly(lactide-co-glycolide) DOI

Yan Wang,

Andrew Otte, Haesun Park

et al.

Journal of Controlled Release, Journal Year: 2024, Volume and Issue: 377, P. 186 - 196

Published: Nov. 19, 2024

Language: Английский

Citations

1
Current Regulatory Framework and Challenges for the Approval of Complex Generics in the US and the EU DOI Creative Commons

Sharvari Patil,

Sandeep Kumar,

Dasari Mallikarjuna Rao

et al.

Current Indian Science, Journal Year: 2023, Volume and Issue: 02

Published: Dec. 11, 2023

Abstract: The pharmaceutical industry is witnessing a growing demand for complex generic products, which are versions of drugs that possess formulations, delivery systems, or active ingredients. However, the approval process these products poses unique challenges compared to traditional generics. There no specific regulatory procedure available generics, unlike smallmolecule generics and biosimilars. This led controversial arguments in past about scientific evidence needed applications, lengthy processes. frameworks currently being used debatable unclear. Complexity molecular structure, mechanism action, route delivery, manufacturing makes proving bioequivalence equivalence difficult. need harmonization framework by agencies help manufacturers providing advice, defining submission requirements fastening process. : review begins discussing landscape surrounding various regions, including United States Europe. It examines guidelines set forth authorities ensure safety, efficacy, quality products. Additionally, explores differences terminology definitions classify across different jurisdictions. Furthermore, it delves into faced both companies evaluating approving These include establishing appropriate criteria, determining interchangeability with reference product, addressing patent exclusivity issues, ensuring consistent throughout product lifecycle. impact on market entry competition also discussed. highlights streamlining regulations worldwide. emphasizes importance clear enable timely approvals, foster innovation, facilitate patient access affordable alternatives.

Language: Английский

Citations

3