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.
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.
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
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.
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.
