CMS: Do No Harm On Biosimilars

As physicians, we are guided by the axiom: “First, do no harm.” The Obama administration would do well to also heed those words as it finalizes its Medicare proposed rule regarding biosimilar drugs. Despite good intentions, the Centers for Medicare & Medicaid Services’ 2016 Medicare Physician Fee Schedule—specifically, its Medicare Part B coding and reimbursement proposal—is poised to do considerably more harm than good to patients, as well as undermine the development of powerful—and badly needed—biosimilar drugs.

“Biosimilars” are medicines derivative of “reference” biologic drugs, which are pharmaceutical treatments derived from living organisms and developed in congruence with the biological workings of the human body. Biologics have transformed the treatment landscape for millions suffering from chronic and life-threatening conditions, from cancer and multiple sclerosis to rheumatoid arthritis and bowel and kidney disease. Biosimilars have the potential to expand access at lower costs to these life-saving medications. But only if we have the right regulatory framework in place.

Biologics and biosimilars are extremely complicated biopharmaceutical products—much more so than traditional, orally taken prescription drugs or their corresponding generics. Unlike these drugs, biosimilars are manufactured in living cell cultures, and therefore can vary greatly based on cell lines used and environmental factors or conditions (such as nutrients, acidity (pH) and temperature) during the manufacturing and purification processes. Such variations can create significant differences in safety and effectiveness compared to reference biologics. Depending on the product and variability, these may not be apparent until the product is used by a large number of patients.

Outside the medical, life-sciences and biopharmaceutical fields, biosimilars are often assumed to be equivalent to generic drugs in the traditional pharmaceutical market. At the most basic level, this seems logical: They both seek to mimic the structure and clinical intent of a precursor product after its patent has expired, often at a lower cost. But that is where the similarities end. While generic drugs are effectively exact copies of their original products, biosimilars are not—the usage of the word “similar” instead of “same” is not by accident.

Incredibly, CMS appears to have built its current regulatory proposal on this incorrect assumption—that all biosimilar products derived from a reference biologic are the same or equivalent to each other. For coding and reimbursement purposes, CMS proposes to combine biosimilars based on their reference biologic. This is like saying apples and oranges are interchangeable because they are both fruits. Except apples and oranges won’t adversely impact the health of patients if they are given the wrong one to eat.

By grouping biosimilars in this manner, CMS is creating the real possibility of patient harm. The Food and Drug Administration will not approve a biosimilar without a strong body of available evidence showing the product is highly similar to its reference. But differences in efficacy and safety may not be detected until a significant number of patients have used the products in question. By lumping all biosimilars under a single “J-Code,” physicians may not be aware of the potential differences—mechanisms of action, interactions and adverse event profiles, for example—potentially leading to serious, negative outcomes for patients.

Oddly, CMS is proposing this rule in direct opposition to the biosimilar regulatory framework developed by the administration’s own FDA, which has yet to even define the interchangeability of a biosimilar to its reference biologic, let alone for biosimilars derived from the same reference biologic. While the FDA is cautiously evaluating each biosimilar on a case-by-case basis, CMS is connecting dots that cannot and should not be connected.

There is one way, however, where the relationship between biologics and biosimilars can be accurately compared to that of traditional brand-name and generic pharmaceutical products: Originator firms in both markets are eager to find ways to undermine the development of these less expensive but equally effective alternatives for patients, the sales of which will cut into their revenues and profits.

With these companies already falsely asserting that biosimilars are less safe than biologics, creating a one-size-fits-all system for the biosimilar market will only reinforce these erroneous claims. If there are safety issues with one biosimilar, the ability to differentiate between biosimilars will be decreased and all biosimilars derived from the same reference product will be deemed unsafe or ineffective. If this occurs, it could slow the development of biosimilars and keep their prices high—effectively removing them as treatment options for physicians and their patients.

From Ebola containment to environmental policy, the Obama administration has repeatedly said that its policies are “based on science.” Well, when it comes to biosimilars, the science is clear: Presuming biosimilars derived from the same reference biologic are therapeutically equivalent by assigning them the same J-Code is dangerous and reckless. CMS needs to rework its proposed rule so that each biosimilar product has a unique classification for coding and reimbursement. If they don’t, it will be patients—including mine—who will suffer the consequences.


Barbara Finck, M.D., serves as Chief Medical Officer for Coherus Biosciences, a leading biosimilar developer.

Morning Consult