Biosimilars are getting approved, but few have hit the market — here's why

The Food and Drug Administration has approved seven biosimilars drugs since 2015, but only three are on the market, reports Bloomberg.

The remaining four drugs are tied up in legal disputes regarding patents for the biologic drugs the biosimilars are copying.

"Basically, there's a gazillion patents," Gillian Woollett, senior vice president of the consulting firm Avalere Health told Bloomberg. "You've got some extremely well-established products with substantial resources behind them."

Biologic drugs are very complex and can have more than 100 patents, which drugmakers often use to hinder biosimilar competition. These legal disputes can keep a biosimilar off the market for years. Drugmakers will also secure exclusive contracts with drug plans and insurers for their brand name biologics to fend off competition from biosimilars.

"It is probably a strategy that drugmakers will continue to pursue," Cynthia Hardman, a partner at Goodwin Procter who focuses on drug patent litigation, told Bloomberg. "These are lucrative products and drugmakers seem to be looking for every avenue they can exploit to protect them and this seems to an effective way, building a patent thicket around their products."

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6 drugmakers in the headlines

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