Search results for " biosimilars"
Article
The Bullish Outlook for Biosimilars
Kuchenreuther, PhD
BioPharm International
There are several important reasons for stakeholders to be optimistic about prospects for biosimilars. During the past few years, questions about th…
Article
Monoclonal Antibodies Key to Unlocking the Biosimilars Market
This growth in large part is due to the fact that numerous monoclonal antibody (mAb) biosimilars are expected to be launched in the next few years as patents on key drugs, such as infliximab (Remicade…
Article
Biosimilars: Making the Switch Comes with Challenges
By Sean Milmo
The use of biosimilars continues to increase strongly in Europe, 10 years after the first biosimilar, a somatropin, was approved by the European Union (EU). With approximately 20 new…
Article
Labeling of Biosimilars
…stage in the lengthy process of creating a regulatory framework for the development and marketing of biosimilars in Europe. In December 2014, guidelines on quality standards for biosimilars with prot…
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Moving Biosimilars Forward in a Hesitant Market
There are 45 biosimilars approved in the United States, which represents amazing progress over the past 10 years or so, remarks John Gabrielson, senior vice-president at JSR Life Sciences and head of …
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
The advent of biosimilars is an opportunity to address affordability. Development costs have been estimated to be reduced to approximately $50 to $300 million and development time to less than eight y…
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Driving Improved Access to Biosimilars
Almost a year after FDA formally issued its Biosimilars Action Plan (3), with the challenging goal of balancing patient safety with innovation, the spring and summer of 2019 brought several US congres…
Article
Biosimilars to Drive Modern Manufacturing Approaches
By Jill Wechsler
As more biosimilars gain market approval in the United States, and manufacturers launch additional programs to develop competitive biotech therapies, regulatory authorities and in…
Article
An Analytical Approach to Biosimilar Drug Development
By Feliza Mirasol
The long-term safety and efficacy of biosimilars are largely based on clinical studies that have already been conducted on the reference biologic, but these studies may…