Results 51 to 60 of about 5,574 (244)

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

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

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

Has The Era Of Slow Growth For Prescription Drug Spending Ended? [PDF]

, 2016
In the period 2005–13 the US prescription drug market grew at an average annual pace of only 1.8 percent in real terms on an invoice price basis (that is, in constant dollars and before manufacturers’ rebates and discounts). But the growth rate increased
Aitken, M., Berndt, Ernst R, Cutler, D., Kleinrock, M., Maini, L.   +4 more
core   +1 more source

Financial Toxicity Associated with Biological Medicines: A Scoping Review

Clinical Pharmacology &Therapeutics, EarlyView.
Financial toxicity, defined as the economic burden experienced by patients due to medication and other healthcare costs and their consequences, such as material, psychosocial and behavioral effects, represents a significant concern for individuals receiving biological medicines.
Laura Sara Maria Saarukka, Kamilla Yamileva, Kari Linden, Anniina Simonen, Anna‐Riia Holmström   +4 more
wiley   +1 more source

Bioengineering of rFVIIa Biopharmaceutical and Structure Characterization for Biosimilarity Assessment [PDF]

, 2018
Eptacog alfa (NovoSeven®) is a vitamin K-dependent recombinant Factor VIIa produced by genetic engineering from baby hamster kidney (BHK) cells as a single peptide chain of 406 residues. After activation, it consists of a light chain (LC) of 152 amino
Eravci, Murat, Hinderlich, Stephan, Mahboudi, Fereidoun, Montacir, Houda, Montacir, Othman, Parr, Maria Kristina, Saadati, Amirhossein, Springer, Andreas   +7 more
core   +2 more sources

Carbon Footprint of Antibody‐Based Drugs and Biologics Using Hybrid Life Cycle Assessment

Clinical Pharmacology &Therapeutics, EarlyView.
Life cycle assessment of monoclonal antibodies. Biological engineering has emerged since the 1980s as one of the most efficient technologies to develop new medicines. The monoclonal antibody platform is the most widely used, representing about 15–20% of drug sales.
Sébastien Taillemite, Martin Fenelon, Marc Scherlinger, Max Piffoux   +3 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

Policy Networks and Policy Entrepreneurship in the EU: Explaining Structural Policy Change in Pharmaceutical Innovation Incentives and Health Technology Assessment

European Policy Analysis, EarlyView.
ABSTRACT Policy process research has excelled in explaining structural policy change within national settings, but extensions and applications to the EU level have long proven challenging for scholars. Given that the EU is currently experiencing its longest period of Treaty stability since the 1980s—having evolved into a sui generis political system ...
Vassilis Karokis‐Mavrikos
wiley   +1 more source

A Comparison of the Immunogenicity of Intravenous BAT1806, a Tocilizumab Biosimilar, and Its Reference Product

Rheumatology and Therapy
Introduction Biosimilars need to demonstrate similarity in terms of quality, pharmacokinetics (PK), efficacy, safety, and immunogenicity. Here, we report the outcome of a comprehensive evaluation of the immunogenicity of the biosimilar BAT1806 compared ...
Hans C. Ebbers, Peter C. Taylor, Xiaomei Leng, Wei Wei, Niamh M. Kinsella, Yinbo Zhou, Xiaolei Yang, Paul Chamberlain   +7 more
doaj   +1 more source