What are the major differences between – Breakthrough Therapy Designation Vs. Fast Track Designation Vs. Priority Review Designation Vs. Accelerated Approval
There is differences between Breakthrough Therapy Designation, Fast Track Designation, Priority Review Designation and Accelerated Approval. Here is a quick comparison of... Read More
European approval for Roche’s tocilizumab for the treatment of giant cell arteritis (GCA)
Posted on24 Sep 2017
Roche, a global pioneer in pharmaceuticals and diagnostics company, announced that the European Commission (EC) has approved Actemra/RoActemra (tocilizumab) for the treatment... Read More
Case Study: USFDA approval of GSK’s Trelegy Ellipta – Triple Drug for COPD
Posted on20 Sep 2017
GSK has won US approval for its triple-therapy inhaler for chronic obstructive pulmonary disease. Brand Name: Trelegy Ellipta Type: Triple Drug Combination... Read More
What is the major difference between biosimilar and interchangeable biological products?
A biosimilar product can be prescribed by a health care provider in place of the FDA-approved reference product. The health care professional... Read More
What is the difference between biosimilar and interchangeable biological products?
There are two new types of biological products- biosimilar and interchangeable. Biosimilars are a type of biological product that are licensed (approved)... Read More
USFDA approval of Avastin biosimilar Mvasi
The USFDA is approved a version of Avastin, a blockbuster chemotherapy made by Genentech that brought in $6.7 billion in sales in... Read More
What is difference between 351(a) vs. 351(k) pathway?
351(a) is the original approval pathway for biologics. It is the pathway for approval of innovator biologics. It is also known as... Read More
What is 351(k) biologics license application (BLA)?
351(k) biologics license application is the biosimilar application process in USFDA. Manufacturers must submit 351(k) biologics license application (BLA) to have a product... Read More
US FDA accepts Sandoz’s proposed biosimilar of rituximab for review
Tags351k, 351k biosimilar, Rituximab
Sandoz, a Novartis Division, and the pioneer and global leader in biosimilars, announced that the US Food and Drug Administration (FDA) has... Read More
Bayer, VUMC strategic research collaboration to develop therapies against kidney diseases
Bayer and Vanderbilt University Medical Center (VUMC), Nashville, Tennessee, US, have entered on a five-year strategic research alliance in the area of... Read More