Report Library
All Reports
BMT Infographic: Biosimilar Development in the US - Top Pharma Considerations
September 18, 2015
In March 2010, the US Biologics Price Competition and Innovation Act (BPCIA), or 351(k) pathway, was enacted to allow an abbreviated
pathway for the licensure of biosimilar therapeutics. Unlike its predecessor, the Hatch-Waxman Act, the 351(k) biosimilar pathway will
unlikely present the observed discounts of chemical generics. Biosimilars are complex in nature and regulatory guidance is more
convoluted. This infographic summarizes the details of our full report that characterizes the biosimilar environment in the US through a
discussion of regulatory pathways, development timelines, and an analysis of US partnerships deals.
Use the link at the top of the page to download the Biosimilars Infographic. A copy of the full Biosimilars Special Report can be downloaded here.
For our disclosures, please read the BioMedTracker Research Standards.
Use the link at the top of the page to download the Biosimilars Infographic. A copy of the full Biosimilars Special Report can be downloaded here.
For our disclosures, please read the BioMedTracker Research Standards.
| Disease Group Covered: |
Allergy
Autoimmune/immunology Cardiovascular Dermatology Endocrine ENT/Dental Gastroenterology (Non Inflammatory Bowel Disease) Hematology Infectious Disease Metabolic Neurology Not Specified Obstetrics/Gynecology Oncology Ophthalmology Orthopedics Psychiatry Renal Respiratory Rheumatology (Non Autoimmune) Urology |
Additional Resources: