RAPS is closely monitoring developments in the Coronavirus (COVID-19) outbreak. See our public safety page for the latest updates.

Regulatory Focus™ > News Articles > 3 > Unpacking an NEJM Perspective on the Lackluster Biosimilar Uptake in the US

Unpacking an NEJM Perspective on the Lackluster Biosimilar Uptake in the US

Posted 01 March 2018 | By Zachary Brennan 

Unpacking an NEJM Perspective on the Lackluster Biosimilar Uptake in the US

Echoing others who have lamented the slow uptake of biosimilars in the US, Richard Frank of the Department of Health Care Policy at Harvard Medical School took his perspective on biosimilar adoption to the New England Journal of Medicine on Thursday.

The perspective does contain a few errors – Frank says there are “only 7 biosimilar products on the US market” but there are really only three (the US Food and Drug Administration (FDA) has approved nine biosimilars in total), and a section on Australia’s biosimilars cites an opinion article from GaBI on Austria (and Australia’s Therapeutic Goods Administration makes no mention of interchangeable biosimilars in its regulation).

Frank explained to Focus that the seven biosimilars mentioned was “from an FDA report from last year and so in the time since the paper was first drafted things may have changed.” However, there have never been seven biosimilars on the US market.

But Frank does capture the general failure of the biosimilars industry to take off en masse in the US, particularly in comparison to the EU. Here's a look at uptake by region from the international IGBA:


With regard to interchangeable biosimilars, which is a designation unique to the US, Frank notes that “FDA issued draft guidance in January 2017 that created confusion in the industry.” 

Commenters on the draft guidance did seek more clarity on the details, and there has not been a major rush in recent years to obtain the designation, though some may be waiting to see how others pursue it and obtaining approval for an interchangeable as opposed to a biosimilar may not necessarily increase uptake rapidly.

Patrick Lucy, chief business office of Boston-based Pfenex, told Focus that in his opinion, the “biggest headwinds to uptake are contracting tactics employed by the reference drug sponsors and IP litigation. Interchangeability is not a huge issue given the influence of payers and price on formulary selection and lack of a pharmacy decision for most Medicare Part B drugs.”

Another expert on biosimilars also debunked the claim Frank makes on “secrecy about manufacturing processes” posing “a potentially significant deterrent to the development of biosimilar competition,” though controlled distribution of reference product and risk evaluation and mitigation strategies (REMS) programs have proven to be barriers.

Biosimilars expert Duncan Emerton told Focus: “While the article is accurate from the 50,000 feet view (i.e. the US biosimilars market has been slow to get going, lots of challenges remain, etc.) it fails on the small details.
And if there’s one thing I’ve learned over the last decade working on biosimilars, it’s the small details that count.”

Frank also touches on how biosimilars in the US are perceived, noting, “Perceived differences between competing products weaken price competition, and the existing evidence suggests that such perceptions are having this effect in the biosimilar market.”

And it remains to be seen how interchangeable biosimilars will be perceived in the US when they come to market, and whether they might be wrongly perceived to be superior to non-interchangeable biosimilars.

Friction in the Path to Use of Biosimilar Drugs

Regulatory Focus newsletters

All the biggest regulatory news and happenings.