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Regulatory Focus™ > News Articles > 2 > Updated: Mixed Bag for Biosimilars in Short-Term Continuing Resolution

Updated: Mixed Bag for Biosimilars in Short-Term Continuing Resolution

Posted 08 February 2018 | By Zachary Brennan 

Updated: Mixed Bag for Biosimilars in Short-Term Continuing Resolution

The US House of Representatives on Tuesday passed another short-term continuing resolution to keep the government open through 23 March, though buried in the bill are two provisions that would impact the biosimilars industry. However, a Senate draft bill unveiled Thursday only contained the one provision that would be positive for the biosimilars industry.

One of the provisions, which the Association for Accessible Medicines (AAM) said it opposes, would prohibit biosimilars from receiving what’s called “pass-through” status in the Medicare Part B Program.

This change, if enacted, would mean that under the Centers for Medicare and Medicaid Services' (CMS) drug discount program, known as 340B, biosimilars would not been reimbursed at ASP plus 6% (of the reference product) rather than ASP minus 22.5%.

The change would likely limit the uptake of biosimilars for reference products that have large 340B markets, such as those coming for Neulasta (pegfilgrastim).

However, another provision in the continuing resolution, which AAM said it supports, would allow the Medicare Part D coverage gap discount program to include biosimilars.

“Without that fix to the Coverage Gap Discount Program, biosimilars would have no path forward to break into Part D formularies and brand biologic products would continue to be preferred,” an AAM spokesman told Focus.

In contrast to the House bill, a Senate draft dated Wednesday evening did not include the pass-through provision, meaning that if the Senate draft gets its way, the continuing resolution would be a win for the biosimilars industry.

Also included in the Senate budget deal is a provision that requires biopharma companies to increase their share, from 50% to 70%, of closing the Medicare Part D donut hole.

Text of the House bill

Text of the draft Senate bill
Editor's note: Article updated on 2/8/18 to include details of the Senate draft.


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