India’s Dr. Reddy’s Aims For Rituximab, Peg-GCSF Biosimilars In U.S.
This article was originally published in PharmAsia News
Executive Summary
The Indian drug maker said it received approvals to conduct safety studies for two biosimilars and is working closely with the regulatory agencies. Analysts expect the trials may take roughly three years following which it will be ready for the product approvals in the U.S. market.
You may also be interested in...
Biosimilar Draft Guidance Outlines Three-Arm Bridging Studies For Non-U.S. Products
Clinical pharmacology data could help biosimilar sponsors pursue a more global development plan.
With Filgrastim, Rituximab And Darebepoetin Alfa Under Its Belt, India's Dr. Reddy's Set To Launch Fourth Biosimilar - Pegfilgrastim
MUMBAI - Keeping with its track record of launching a range of biosimilars before its peers, India's Dr. Reddy's Laboratories Ltd. is set to launch its indigenously developed pegylated filgrastim - a version of Amgen Inc.'s blockbuster Neulasta used to boost white blood cells in patients undergoing chemotherapy. Neulasta had global sales of around $3.6 billion last year, said an expert in the biotechnology industry
Indian Investors Turn Cautious On Compliance Concerns
A rising number of enforcement actions by major drug regulators like the U.S. FDA is slowly making investors cautious about the longer term repercussions on earnings of Indian drug makers.