A recent study estimates that allowing biosimilar manufacturers to provide discounts to seniors
in the coverage gap would reduce patient out-of-pocket costs and lower Medicare spending.

What are the facts?

Biosimilar medicines are safe, effective and affordable versions of costly brand biologics and have the potential to save the Medicare Part D program billions of dollars.

Currently, biologic medicines are one of the only treatments available for many serious illnesses, like cancer or genetic disorders, but they come at a steep expense.

A biosimilar – much like a generic – is an FDA-approved highly similar version of a branded biologic prescription drug, which has no clinically meaningful differences in terms of safety and effectiveness, and comes with a much lower price tag.

Estimated savings to the U.S. healthcare system over 10 years

$250 billion

With seven FDA-approved biosimilars to date and many more in development, experts estimate that increased entry and use of biosimilars could save the healthcare system as much as
$250 billion over a 10-year period

However, under current law, patients that fall in the Medicare Part D coverage gap or “donut hole”, who would qualify for discounts on brand-name drugs, do not receive that same benefit on biosimilars. This results in higher out-of-pocket costs for lower-cost medicines.

In fact, the current law makes it impossible for biosimilar producers to offer the same discounts to Medicare Part D that branded biologic makers not only can – but must – offer.

Biosimilars are Safe, Effective, More Affordable
& Offer Improved Patient Access

Comparable safety and efficacy as their biologic counterpart.

Same mechanism
of action

Rigorous FDA testing and review; less cost to patients and the health system

Companies that manufacture biosimilars are committed to providing safe, effective products

Not only is the fix simple and critical to patients, but a recent study estimates that allowing biosimilar manufacturers to provide discounts to seniors in the coverage gap would reduce federal spending by $1 billion over 10 years.

Congress can’t afford to wait any longer.

Join us in urging lawmakers to fix the Part D coverage gap discount program to classify biosimilars as “applicable drugs” in the Coverage Gap Discount Program.

This change would allow biosimilar manufacturers to pay the 50 percent discounts paid by their brand competitors, and participate on a level playing field to compete for placement on Part D plans’ formularies. Most importantly, it would reduce both patient out-of-pocket costs and Part D program spending.


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