4 Ways the U.S. Biopharma Industry is Pushing Back on Biosimilars


Europe began approving biosimilars in 2006. The U.S. has lagged behind, only starting to approve these copycat drugs in 2015. However, of the nine biosimilars approved in the U.S., only three are actually on the market because of barriers thrown up by the biopharma industry.

A biosimilar is essentially a generic version of a biologics drug. But unlike a generic drug, which is an exact copycat of a branded drug, a biosimilar is “similar” to a branded biologic, but not a direct copycat. As a result, biosimilars require clinical trials and more regulatory approvals before hitting the market.

An IMS Institute report, which was funded by Novartis, projected that without biosimilar competition, a total of $225 billion would be spent on eight top-selling biologics in the U.S. and five European countries, Germany, France, Italy, Spain and the UK, between 2016 and 2020. Those eight biologics are losing patent protection and the IMS calculated that the cumulative savings from biosimilar competition from 2015 to 2020 could range from $45 billion to $90 billion.

Which goes a long way to explaining both the appeal of biosimilars and the problems—for biopharma—caused by biosimilars.

There’s a lot of money involved. But for companies with brand-name biologics that often have six-figure prices, biosimilar competition will eat into their profits. For the companies manufacturing biosimilars—often companies that themselves are facing biosimilar competition—it’s a shot at a piece of all that revenue.

For consumers, biosimilars are more widely available versions of expensive biologics at a lower price. Christine Simmons, executive director of the Biosimilars Council, a division of the Association for Accessible Medicines, writes for STAT, saying, “As of April 1 of this year, the FDA had 63 ‘programs’ or applications for biosimilar review, representing competition for 31 brand-name biologics (also known as a reference products). These biosimilars, if approved, will improve patient access to very expensive treatments for complex conditions at lower costs. Biosimilars provide competition to costly biologic medicine that are used by less than 2 percent of Americans but that account for more than 26 percent of drug spending.”

In January 2018, the U.S. Food and Drug Administration (FDA) announced a Biosimilar Innovation Plan, which would make way for more biosimilar development and approval. FDA Commissioner Scott Gottlieb said in a statement, “In focusing on these selected efforts, we will optimize our resources to achieve clear deliverables that will yield results over the next [2] years. Publishing this Roadmap is another way that we aim to provide more transparency about the FDA’s policy undertakings to all our stakeholders.”

Simmon, however, writes, “While FDA support is necessary to achieving a robust biosimilars market, it is not by itself sufficient. That’s because while the agency and many policymakers and health care stakeholders are seeking to foster biosimilar competition, powerful forces seek to thwart it.”

She cites four tactics being used to battle biosimilars.

  1. Gaming the FDA’s Risk Evaluation and Mitigation Strategies. Although designed to protect patients, she writes, they “are increasingly used to restrict biosimilar makers from gaining access to samples of brand-name biologics needed for biosimilar development.”


  1. Patent expansion. Biopharma companies are filing more and more “non-innovative” patents on the drugs they want to protect, forcing biosimilar manufacturers to weave their way through a maze of patent lawsuits.


  1. Rebate traps. Simmons writes, “Upon market entry of a competitive biosimilar, some brand manufacturers have threatened to remove the rebates they provide to payers unless the biosimilar is effectively excluded from the market.”


  1. Distorted marketing. Simmons indicates that some companies are disseminating misleading information or raising concerns about the safety and effectiveness of biosimilars, even though they must go through a stringent FDA testing and review program similar to those for new drugs.

Simmons writes, “These barriers have forced the U.S. biosimilars industry into a perpetual state of infancy and cost patients and taxpayers more than $5 billion each year.”

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