Search results for " biosimilarity"
Article
The Bullish Outlook for Biosimilars
Feb 01, 2015
By Jill E. Sackman, PhD, Michael J. Kuchenreuther, PhD
BioPharm International
There are several important reasons for stakeholders to be optimistic about prospects for b…
Article
Monoclonal Antibodies Key to Unlocking the Biosimilars Market
…h larger and more complex molecules that can be difficult to fully characterize and thus demonstrate biosimilarity. This complexity requires more complex manufacturing processes, according to Kate Ke…
Article
Biosimilars: Making the Switch Comes with Challenges
“Patients are concerned about the new product [while] physicians are not comfortable about explaining the principle of biosimilarity,” Lunddahl explained (4).
The issue of variability
A drive …
Article
Labeling of Biosimilars
“The inclusion of the preclinical and clinical data [only] on the biosimilar is misleading because the assessment of biosimilarity is primarily based on extensive analytical comparisons [on quality] w…
Article
Moving Biosimilars Forward in a Hesitant Market
This is partly due to the hesitancy among doctors and patients regarding the difference between biosimilarity and interchangeability, both Bukhari and Gabrielson specify.
“I think [this perception…
Article
Reviewing the Importance of Biosimilarity and Interchangeability
Biosimilarity versus interchangeability
In biosimilars development, it is not enough to establish analytical evidence of the product’s biosimilarity to the reference product, but also its interchang…
Article
Reimagining Affordable Biosimilars
Other challenges for biosimilars are frequent failures in demonstration of biosimilarity and establishment of clinical equivalence for efficacy, immunogenicity, and safety (5). There is a growing need…
Article
Driving Improved Access to Biosimilars
Driving Improved Access to Biosimilars
New guidance from FDA, including standards for interchangeability, is expected to speed development of biosimilars, but experts warn against oversimplifying ri…
Article
Biosimilars to Drive Modern Manufacturing Approaches
Reliable, high-quality products require innovative analytics and production.
By Jill Wechsler
As more biosimilars gain market approval in the United States, and manufacturers launch addition…
Article
An Analytical Approach to Biosimilar Drug Development
Analytical similarity by itself is not designed to ‘ensure’ biosimilarity, but is a first step in the stepwise approach to the development of biosimilars. The comparability/similarity of the quality a…