Results 201 to 210 of about 5,547 (244)

An assessment of the inter-relationships between European patent litigation, regulation and the arrival of biosimilar pharmaceuticals on the European market

, 2016
openaire   +1 more source

Can biosimilar products be interchangeable? Pharmaceutical perspective in the implementation of biosimilars in oncology

Journal of Oncology Pharmacy Practice, 2021
Objective To evaluate the safety in the interchangeability of biosimilar products approved for cancer treatment from a pharmaceutical perspective. Methods A literature review was carried out using the descriptors “Biosimilar”, “Oncology Therapy”, “Interchangeable drugs” and “Biological Products”, in the Sciencedirect, MEDLINE, and CAPLUS databases ...
José Cleberson Santos Soares, Iago Dillion Lima Cavalcanti, Juliana Lúcia de Albuquerque Vasconcelos   +2 more
openalex   +3 more sources

Quality by Design applications in biosimilar pharmaceutical products

Accreditation and Quality Assurance, 2008
A process is well understood when all critical sources of variability are identified and explained, variability is managed by the process design and monitoring, and product quality attributes are accurately and reliably predicted over the design space.
Ron S. Kenett, Dan A. Kenett
openalex   +2 more sources

Biotechnological therapies and biosimilars for COVID-19: scarcities, poor regulation, and pharmaceutical black market: a case analysis in Ecuador

Generics and Biosimilars Initiative Journal, 2021
At the beginning of the COVID-19 pandemic, Ecuador was unprepared for the overwhelming number of COVID-19 cases. As the general population started to see the eff ects of the pandemic, unproven treatments and medications were sought by the population to try to ameliorate the impact of the pandemic.
Esteban Ortiz‐Prado, Enrique Terán, Raul Patricio Fernandez Naranjo, Doménica Cevallos-Robalino, Jorge Vásconez-González, Alex Lister   +5 more
openalex   +2 more sources

HPR151 New Proposed European Commission Pharmaceutical Regulation – Potential Changes and Impact on Biosimilars

Value in Health, 2023
Beow Keat Yap, Myles J. Watts
openalex   +2 more sources

Efforts of the Pharmaceuticals and Medical Devices Agency of Japanese regulatory agency in supporting biosimilar development and disseminate information

Naunyn-Schmiedeberg's Archives of Pharmacology
Information on biosimilars was rarely disseminated on the Pharmaceuticals and Medical Devices Agency (PMDA) website of the Japanese Regulatory Agency until the fiscal year (FY) 2022. Therefore, the PMDA website for biosimilars was created in FY 2023.
Ryosuke Kuribayashi, Aya Hariu, Yuka Saino, K. Shinohara   +3 more
openalex   +3 more sources

PHARMACEUTICALS Merck deal with South Korea’s Hanwha bolsters move into biosimilars

Chemical & Engineering News Archive, 2011
Lisa Jarvis
openalex   +2 more sources

Some of the next articles are maybe not open access.

Related searches:

Addressing the health technology assessment of biosimilar pharmaceuticals

Current Medical Research and Opinion, 2010
Abstract The growing number of biosimilars presents challenges to regulatory and health technology assessment (HTA) systems. This paper illustrates these challenges by focusing on biosimilars used in the oncological setting. In particular, discordances between data required by regulatory and HTA authorities potentially deprive patients of effective ...
Alan, Stewart, Philip, Aubrey, Jonathan, Belsey   +2 more
openaire   +2 more sources

The Japan PDMA will require pharmaceutical companies to include risk management plans in all applications, for new drug or biosimilar products,

Reactions Weekly, 2012
&NA;
  +5 more sources