Biosimilars
Biosimilars are saving money but not in the U.S., where companies have used a variety of stalling tactics. Now Pfizer and others are accusing Johnson & Johnson of withholding rebates to fend off biosimilar competition to Remicade.
Thomas Reinke
The TNF-α blocker is the world’s top-selling drug, by revenue. It faces biosimilar competition in Europe, but it will be four years before it’s challenged in the U.S.
Susan Ladika
The price of biologics can ruin cancer patients financially, this leading oncology expert reminds us. Biosimilars may help, but we need more of them on the market.
Interview by Peter Wehrwein

16 FDA-approved Biosimilars

Shaded rows indicate products on the market as of Jan. 14, 2019

  1. Herzuma (trastuzumab-pkrb, Celltrion and Teva)
  2. Truxima (rituximab-abbs, Celltrion)
  3. Udenyca (pegfilgrastim-cbqv, Coherus BioSciences)
  4. Hyrimoz (adalimumab-adaz, Sandoz)
  5. Nivestym (filgrastim-aafi, Pfizer)
  6. Fulphila (pegfilgrastim-jmdb, Mylan)
  7. Retacrit (epoetin alfa-epbx, Hospira*)
  8. Ixifi (infliximab-qbtx, Pfizer)
  9. Ogivri (trastuzumab-dkst, Mylan)
  10. Mvasi (bevacizumab-awwb, Amgen)
  11. Cyltezo (adalimumab-adbm, Boehringer Ingelheim)
  12. Renflexis (infliximab-abda, Merck)
  13. Amjevita (adalimumab-atto, Amgen)
  14. Erelzi (etanercept-szzs, Sandoz)
  15. Inflectra (infliximab-dyyb, Celltrion and Pfizer)
  16. Zarxio (filgrastim-sndz, Sandoz)

*Hospira is a subsidiary of Pfizer.

Complete list, with indications

Biosimilar News Wire

Medication can launch in Europe a year from now
September 30, 2017
Cyltezo from Boehringer Ingelheim joins Amjevita from Amgen
August 28, 2017
Renflexis also costs 20% less than a biosimilar already on the market
July 24, 2017
Justices overturn six-month waiting period
June 12, 2017
They are ‘living’ molecules, and there is variability among lots, even in the reference products. The key issue is whether the variability has any clinical significance. So far, it hasn’t.
Thomas Reinke
The FDA commissioner has an 11-step ‘action plan’ to get biosimilars out of a repeat mode of unrealized potential. But issues like interchangeability still need clarifying if biosimilars are to have a major effect on drug expenditures.
Richard Mark Kirkner