“Will 2021 be another break-through year for biosimilars?” asks Forbes in an article this month.
Written by healthcare analyst Joshua Cohen Pd.D., the article discusses the rising use of biosimilars which he calls “remarkable.”
“The latest data show that physician-administered biosimilar drugs are successfully displacing their reference biologics,” Cohen writes. “Newer biosimilars are being adopted faster than before, due in large part to declining prices.”
Biosimilars are sometimes confused with generic drugs. Though there are similarities, chiefly in that they have the same clinical effect as the more costly brand name formulations, the difference is that biosimilar drugs are highly similar, but not identical to the brand names. The other difference is that generics are copies of synthetic drugs, while biosimilars are based on drugs developed using living organisms such as bacteria, animal or plant cells.
Like generics, biosimilars are significantly less expensive than the brand name counterparts. These original drugs are referred to as “reference” or “originator” products.
As the chart prepared by the Drug Channels Institute shows, the market share of some of the newest biosimilars is growing rapidly.
Their use would increase even more rapidly, writes Cohen, if the Food and Drug Administration granted biosimilars interchangeability status. A biosimilar product that meets the requirements of the Biologics Price Competition and Innovation Act will be given interchangeable approval, meaning a pharmacy can substitute it for the original, brand name without the involvement of the prescribing doctor.
Currently, that’s one of two big obstacles to biosimilar sales. Doctors must specifically prescribe the biosimilar. Most do not out of habit, familiarity with the existing brand name and because so many health plans do not cover biosimilars.
As Adam J. Fein, PhD, CEO of the Drug Channels Institute, explains, “biosimilars are often not preferred over reference products at many of the largest U.S. commercial health plans. Physician preferences can slow adoption, too. A 2019 survey found that a majority (61%) of oncology physicians still prefer not to use biosimilars, use them only for supportive care, or prefer not to switch patients.”
Congress is expected to act next year on a bill with bipartisan support that incentivizes the use of biosimilars by changing the reimbursement formula for brand-name drugs and biologics, Cohen says. Since most biosimilars are physician-administered, improving the reimbursement rate is hoped to be enough of an incentive for doctors to make the switch.
One estimate from the Wall Street analyst firm Bernstein Research puts the annual savings from the use of biosimilars at $6.5 billion.
Calling 2020 an “inflection point,” Fein says, “The biosimilar market is finally beginning to fulfill its promise.”
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