Big Molecule Watch
August 31, 2016

Drug Costs Study Argues for Increased Funding for Biosimilar Review

A recent meta-analysis investigated several factors impacting prescription drug costs in the United States.  Doctors associated with the Brigham and Women’s Hospital and Harvard Medical School authored the report.  Funding was provided by a grant from the Laura and John Arnold Foundation, with additional support from the Engelberg Foundation.  The researchers generally concluded that generic competition, including biosimilars, is the primary means of reducing drug prices in the United States, arguing that increased competition is needed to reduce drug costs.

The study noted that biologics are often some of the more expensive drugs on the market, but that direct competition among biologics has been rare.  It also observed that under the new BPCIA framework, only two biosimilars have been approved.  (The FDA approved a third biosimilar after the study published.)  To improve the biosimilars market, the report called for allocating greater resources to the FDA to review biosimilar applications; promulgating product-specific guidance on interchangeability; and conducting rigorous postmarket surveillance to continually assess safety and efficacy.

At the same time, the study commented on the complexities of biosimilar pricing.  The study noted that a biosimilar of epoetin alfa (Epogen) saw median price savings of 35% in the European Union, but those savings ranged from 6% to 79%, depending on the country and its price negotiating power.  In the United States, a biosimilar of filgrastim (Neupogen) has been offered at a 15% discount.  According to the article, negotiating power in the United States is somewhat limited as most government payment plans are required to cover nearly all products.

Big Molecule Watch will continue to monitor research relevant to the biosimilars market, so check back for further news and updates.