Faget Comments on Likely Effects of HHS Proposal to Curb Rebates

20 February 2019 BioPharm Insight News
Special Counsel Kyle Faget is quoted in a BioPharm Insight article, “Biosimilars, diabetes and HCV drug uptake expected to spike with HHS changes restricting safe harbor protection for PBMs and drug manufacturers, experts say,” about the expected impact of a new U.S. Department of Health and Human Services proposal to exclude rebates on prescription drugs from safe harbor protection under the anti-kickback statute.

Faget said an obstacle to automatic biosimilar uptake under the proposal may be that as opposed to generics, pharmacists cannot automatically switch out an originator for a biosimilar, unless interchangeability has been established by the biosimilar maker. She cited the example of Pfizer’s Ixifi, which can’t be substituted for Remicade by a pharmacist even if it’s cheaper. Remicade is approved to treat a number of indications, including rheumatoid arthritis, psoriatic arthritis, Crohn’s disease, ulcerative colitis, plaque psoriasis, and ankylosing spondylitis.

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