Biosimilars

Roche

Note from the editor

Only three biosimilars, the copycat versions of drugs like Humira and Enbrel, were approved by the Food and Drug Administration last year, a significant slowdown after 10 were cleared for use in 2019.

All told, 29 biosimilars are now approved, although only 20 have launched commercially as patent litigation has kept the others from reaching consumers.

Although the market has widely fallen short of expectations since approval of the first U.S. biosimilar in 2015, recent biosimilar launches have offered modestly steeper discounts, suggesting multiple competitors could start to bring down prices more considerably.

Overall, most biosimilars list for a price between 15% and 30% of what the branded version costs — sizable yet far from the 80% savings generics often bring. Two newer copies of Amgen's Neulasta, however, were made available at a 37% discount, while Amgen recently set the price of its biosimilar for J&J Remicade's 57% below that drug's wholesale price tag.

​Many of the top-selling drugs in the U.S. are biologics and even a moderate discount on tens of billions of dollars in drug spending could be substantial.

Even so, there remains spirited debate between experts and former government officials over whether the biosimilar experiment is even worth the effort.

Translating biosimilars' savings potential into reality has been the sticking point. Despite six approved biosimilars to Humira, the world's top-selling medicine, none have launched due to the dense thicket of patents AbbVie has built around the inflammatory disease drug. A recent court decision, meanwhile, could keep biosimilars to Amgen's Enbrel off the market until 2029.

Ned Pagliarulo Lead Editor

AbbVie fends off biosimilar challengers to Humira until 2023

• Published May 14, 2019

Humira patents take center stage as House panel targets AbbVie pricing

• Published May 18, 2021

Novartis challenge to Amgen's Enbrel patents ends at Supreme Court's door

• Published May 18, 2021

US biosimilar market was slow to get going, but some urge patience

• Published June 26, 2019

Biogen adds a late-stage prospect to its growing biosimilar business

• Published April 8, 2021

FDA finalizes interchangeable biosimilar advice, with insulin focus

• Published May 13, 2019

The state of biosimilars in 2021

Although the U.S biosimilars market has fallen short of expectations since its first product approval in 2015, the past 12 months suggest a hastening maturation. With only 20 biosimilars currently available in the U.S, greater price competition could emerge as more biosimilars of each drug begin to launch.

included in this trendline
  • Roche cancer drugs face biosimilar test as Amgen, Allergan copies launch
  • AbbVie fends off biosimilar challengers to Humira until 2023
  • Third Neulasta biosimilar launches as Sandoz wins long-delayed FDA approval
Our Trendlines go deep on the biggest trends. These special reports, produced by our team of award-winning journalists, help business leaders understand how their industries are changing.
Davide Savenije Editor-in-Chief at Industry Dive.