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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.
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

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