Results 51 to 60 of about 5,542 (243)

Through the lens of marketing authorization holders: experience in use of real‐world data and real‐world evidence in drug development and regulatory submissions in EU

British Journal of Clinical Pharmacology, EarlyView.
Abstract Aim The aim of this study was to assess the general and product‐specific experiences of MAHs use of RWD/RWE in medicines development and in their regulatory submissions, and to explore organizational aspects of MAHs related to RWD/RWE. Methods An electronic survey was conducted, and information collected directly from MAHs.
Sini M. Eskola, Aleksandar Gigov, Hubertus G. M. Leufkens, Andrew Bate, Marie Louise De Bruin, Helga Gardarsdottir   +5 more
wiley   +1 more source

Manufacturing Barriers to Biologics Competition and Innovation [PDF]

, 2016
As finding breakthrough small-molecule drugs gets harder, drug companies are increasingly turning to “large molecule” biologics. Although biologics represent many of the most promising new therapies for previously intractable diseases, they are extremely
Price, W. Nicholson, II, Rai, Arti K.
core   +2 more sources

Do drugs approved via expedited approval pathways have therapeutic advantages? A systematic review and meta‐analysis

British Journal of Clinical Pharmacology, EarlyView.
Regulators use expedited approval pathways to speed market approval and patient access to promising new drugs. However, there is uncertainty about whether these pathways are successful in approving drugs with significant therapeutic advantages. This systematic review aims to examine the safety, effectiveness and cost‐effectiveness of drugs approved via
Ashleigh Hooimeyer, Eliza J. McEwin, Zhicheng Wang, Joel Lexchin, Barbara Mintzes   +4 more
wiley   +1 more source

Emergence of the Biosimilar Sector and Opportunities of Developing Country Suppliers [PDF]

, 2011
As biologic products begin to come off-patent, a market is emerging for biosimilars (also known as biogenerics or follow-on biologics). Firms from emerging countries such as India and China have dominated the production of active ingredients in ...
Huzair, Farah, Kale, Dinar
core  

Predictive glycoengineering of biosimilars using a Markov chain glycosylation model [PDF]

, 2016
Biosimilar drugs must closely resemble the pharmacological attributes of innovator products to ensure safety and efficacy to obtain regulatory approval. Glycosylation is one critical quality attribute that must be matched, but it is inherently difficult ...
Hansen, Anders Holmgaard, Kol, Stefan, Lewis, Nathan E., Spahn, Philipp N., Voldborg, Bjørn Gunnar   +4 more
core   +1 more source

Artificial intelligence and machine learning‐assisted digital applications for biopharmaceutical manufacturing

Biotechnology Progress, EarlyView.
Abstract Artificial intelligence and automation are no longer just buzzwords in the biopharmaceutical industry. The manufacturing of a class of biologics, comprising monoclonal antibodies, cell therapies, and gene therapies, is far more complex than that of traditional small molecule drugs.
Shyam Panjwani, Hao Wei, John Mason
wiley   +1 more source

Market Access Analysis of Biologics and Small-Molecule Inhibitors for Inflammatory Bowel Disease Among US Health Insurance Policies. [PDF]

, 2019
BACKGROUND AND AIMS:Treatment pathways for ulcerative colitis (UC) and Crohn's disease (CD) are shifting to a more individualized, risk-stratified approach.
Cao, Charlie, Dulai, Parambir S, Lasch, Karen, Osterman, Mark T, Riaz, Faisal, Sandborn, William J   +5 more
core  

Measuring the Impact of the Substitution of Innovator Biologics With Biosimilars on Uptake and Costs Among Ontario Public Drug Benefit Recipients

Clinical Pharmacology &Therapeutics, EarlyView.
In Ontario, biologics have historically represented a small proportion of public drug claims but a large proportion of spending. Biosimilars, lower cost alternatives to biologics, offer a potential solution to the rising spending on biologics. From March 2023 to January 2024, the Ontario Ministry of Health required public drug program beneficiaries on ...
Anita Iacono, Martin K. H. Ho, Joanna Yang, Tonya Campbell, William Wynne, Dana Shearer, Lene Andersen, Eric Majer, Shaleesa Ledlie, Mina Tadrous, Tara Gomes   +10 more
wiley   +1 more source

Treatment Patterns, Effectiveness, and Safety of Originator Insulin Glargine versus Insulin Glargine-yfgn within the Veterans Health Administration

Pharmacoepidemiology
We described insulin glargine (originator) and insulin glargine-yfgn (biosimilar) treatment patterns, assessed effectiveness and safety outcomes, and identified reasons for switching back to the originator product from the biosimilar.
Samantha Walczuk, Francesca E. Cunningham, Xinhua Zhao, Diane Dong, Peter A. Glassman, Donald R. Miller, Deborah Khachikian, Anthony Au, Cedric Salone, Kelly Bryan, Qoua Her, Sherrie L. Aspinall   +11 more
doaj   +1 more source

More Than a Question of Correlation: Characterization of the Evidentiary Basis for Biomarker Surrogates Used in European Marketing Authorizations

Clinical Pharmacology &Therapeutics, EarlyView.
Traditionally, clinical outcomes measuring how a patient feels, functions, or survives are preferred endpoints in clinical trials; however, some may take a long time to manifest in slowly developing diseases. Biomarkers, if properly validated, can serve as surrogate endpoints, acting as substitutes for clinical outcomes.
Renske Johanna Grupstra, Viktoriia Starokozhko, Elisabeth Bakker, Anna Maria Gerdina Pasmooij, Peter Gerardus Maria Mol   +4 more
wiley   +1 more source