Progress and Hurdles for Follow-on Biologics

N Engl J Med. 2015 Jun 18;372(25):2380-2. doi: 10.1056/NEJMp1504672. Epub 2015 May 6.

Authors

Ameet Sarpatwari¹, Jerry Avorn, Aaron S Kesselheim

Affiliation

¹ From the Program on Regulation, Therapeutics, and Law (PORTAL), Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston.

PMID: 25946143
DOI: 10.1056/NEJMp1504672

No abstract available

MeSH terms

Biological Products*
Drug Approval / legislation & jurisprudence*
Drug Industry
Drugs, Generic* / economics
Government Regulation
Prescription Fees
Therapeutic Equivalency
United States
United States Food and Drug Administration

Substances

Biological Products
Drugs, Generic