GaBI - Generics and Biosimilars Initiative

21/02/2025

Estratégia para o lançamento de um produto inovador na indústria farmacêutica brasileira. O caso de um medicamento para tratamento de Covid-19

Estratégia para o lançamento de um produto inovador na indústria farmacêutica brasileira O caso de um medicamento para tratamento de Covid-19 Autores Ligia Maura Primo Maluf UNIVERSIDADE PRESBITERIANA MACKENZIE Adilson Caldeira Universidade Presbiteriana Mackenzie Reynaldo Cavalheiro Marcondes U...

19/02/2025

Indonesia works toward pharmaceutical independence

Indonesia's Health Ministry is expediting efforts to achieve domestic pharmaceutical independence to address the evolving needs of the national health ...

19/02/2025

EC approves eight biosimilars, eight more await final authorization

The European Commission (EC) granted marketing authorization for seven biosimilars: Sandoz’s Afqlir, Formycon’s Ahzantive/Baiama,...

17/02/2025

Efeitos da entrada de genéricos no mercado sobre os preços de medicamentos

14/02/2025

Seizing opportunities in a changing medicines landscape
The European medicines agencies network strategy 2028 (draft)

12/02/2025

Ventajas e inconvenientes de los biosimilares en Oftalmología

Autorías: H. Peñate Santana, Vicent Alonso Pons, A. Alemán Pérez, N. Cáceres Herrera, D. Rodríguez Cruz, R. Benítez Suárez, C. Santana Artiles, D. Suárez Medina. Localización: Archivos de la Sociedad Canaria de Oftalmología. Nº. 35, 2024. Artículo de Revista en Dialnet.

11/02/2025

GaBI Journal, Volume 13, 2024, Issue 3, Now Available -

Manuscripts on all aspects of generic and biosimilar medicines covering areas in clinical, fundamental, technical, manufacturing, bioprocessing, economic and social aspects of pharmaceuticals and therapeutics are welcome. In addition, high quality work submitted in other formats, for example, scien...

10/02/2025

National and International Policies on the Use of Biosimilars: An Environmental Scan
https://canjhealthtechnol.ca/index.php/cjht/article/view/PR0006

07/02/2025

Canada approves first omalizumab biosimilar Omlyclo
https://www.gabionline.net/biosimilars/news/canada-approves-first-omalizumab-biosimilar-omlyclo

03/02/2025

Pharmacokinetic bioequivalence studies of a new Etoricoxib tablet formulation developed using proprietary MiST technology — risk assessment and mitigation using GastroPlus software

Author byline as per print journal: Dhananjay Panigrahi1, MPharm; Aditya Murthy2, MPharm, PhD; Shubham Jamdade2, MPharm; Manoj Gundeti2, MPharm; Nagarjun Rangaraj1, MPharm, PhD; Anup Avijit Choudhury1, MPharm; Tausif Ahmed2, MPharm, PhD; Venkat Ramana Naidu1, MPharm, PhD Introduction: In this work,....

31/01/2025

Therapeutic Equivalence of Biosimilar and Reference Biologic Drugs in Rheumatoid Arthritis
A Systematic Review and Meta-analysis

This systematic review and meta-analysis assesses the efficacy, safety, and immunogenicity associated with biosimilars of adalimumab, etanercept, and infliximab compared with their reference biologics for patients with rheumatoid arthritis.

29/01/2025

Positive safety and efficacy primary endpoint results for AVT05 (golimumab proposed biosimilar)
https://www.gabionline.net/biosimilars/research/positive-safety-and-efficacy-primary-endpoint-results-for-avt05-golimumab-proposed-biosimilar

27/01/2025

Are interchangeable biosimilars at risk?

In the US, the interchangeability designation earned by some biosimilars, now allows them to be substituted at pharmacy level, without physician ap...

24/01/2025

Current understanding, knowledge, and perception of biosimilars in a changing landscape of regulatory requirements

Author byline as per print journal: Andriy Krendyukov, MD, PhD; Marta Bakowska, BA (Hon), MPH; Dirk Schiller, PhD; Sanjay Singhvi, BSc (Hon), MBBS, MBA Introduction: Healthcare providers often lack familiarity with the concepts surrounding the biosimilars industry and the evidence required to suppor...

22/01/2025

Ustekinumab biosimilars Yesintek, Steqeyma, and Otulfi approved by FDA, EMA and Health Canada
https://www.gabionline.net/biosimilars/news/ustekinumab-biosimilars-yesintek-steqeyma-and-otulfi-approved-by-fda-ema-and-health-canada

20/01/2025

The future of European competitiveness – In-depth analysis and recommendations

17/01/2025

The patentability and bioethics of molecular de-extinction

The resurrection of strings of extinct molecules raises intriguing questions of patentability and bioethical considerations in an emerging area of patent law.

16/01/2025

EMA recommends approval for four denosumab biosimilars: Obodence, Osenvelt, Stoboclo, Xbryk

The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) issued a positive opinion recommendin...