FDAnews Drug Daily Bulletin

Biosimilars Council Says Patent Abuse Chills Competition, Costs Billions

July 12, 2019

Biosimilar companies are hamstrung by patent schemes, misguided legislation, rebate traps and other hurdles to market entry that have cost the U.S. healthcare system $7.6 billion since 2015, the Biosimilar Council claims in a new analysis.

In late June, the FDA approved Pfizer’s Zirabev (bevacizumab-bvzr), the 21st biosimilar in the U.S. But only seven biosimilars are commercially available. That’s “a direct result of the patent schemes used by some brand-name pharmaceutical companies to maintain their lucrative product pricing monopolies beyond the period Congress deemed reasonable,” the council says.

The paper, titled “Failure to Launch,” rails against the patent thickets that drugmakers create to protect the exclusivity of their biologics. “In many cases, these late-stage patents are filed when there have been no changes made to the product manufacturing process or the underlying product itself,” the council says.

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