“The IRA’s drug pricing controls and Medicare redesign are likely to have a material adverse effect on our sales, our business and our results of operations, and such impact is expected to increase through the end of the decade and will depend on factors including the extent of our portfolio’s exposure to Medicare reimbursement, the rate of inflation over time, the number of our products selected for mandatory price setting and the timing of market entry of generic or biosimilar competition”
All entries for: Biologic
October 31, 2023
Amgen
Negative Outlook
Thousand Oaks, CA
10,001-50,000 employees
10001-50000 employees
Drug Type: Biologic
October 27, 2023
Vir Biotechnology
Negative Outlook
San Francisco, CA
201-500 employees
201-500 employees
“Accordingly, while it is currently unclear how the IRA will be effectuated, we cannot predict with certainty what impact any federal or state health reforms will have on us, but such changes could impose new or more stringent regulatory requirements on our activities or result in reduced reimbursement for our products, any of which could adversely affect our business, results of operations and financial condition.”
Disease Area: Antiviral, Multiple, Oncology
Drug Type: Biologic, Small Molecule
October 26, 2023
Bristol Myers Squibb
Negative Outlook
Princeton, NJ
10,001-50,000 employees
10001-50000 employees
“On June 16, 2023, BMS filed a lawsuit against the U.S. Department of Health & Human Services and the Centers for Medicare & Medicaid Services, et al., challenging the constitutionality of the drug-pricing program in the IRA. That program requires pharmaceutical companies, like BMS, under the threat of significant penalties, to sell certain of their medicines at government-dictated prices”
Disease Area: Multiple
Drug Type: Biologic, Small Molecule
October 26, 2023
Seagen
Discontinued Drug, Discontinued Research
Bothell, WA
1,001-5,000 employees
1001-5000 employees
“Seagen Inc. ended a program to study one of its drugs to treat an early-stage form of bladder cancer because it would have been subject to government price negotiations shortly after approval, Chief Executive Officer David Epstein said.
The company had been looking into using its drug Padcev to treat the nonmuscle-invasive version of the disease that accounts for about 70% of newly diagnosed bladder cancer cases. It stopped after determining that there would be no financial return from the potential use, as approval would have likely come soon before the drug became subject to price bargaining under the Inflation Reduction Act…”
1 Discontinued Drug: Padcev (biologic)
1 Discontinued Research Program
Disease Area: Oncology
Drug Type: Biologic
October 6, 2023
Horizon Therapeutics
Negative Outlook
Deerfield, IL
1,001-5,000 employees
1001-5000 employees
During HZNP’s earnings call, Madhu Kumar of Goldman Sachs inquired whether the Inflation Reduction Act’s drug pricing provisions have altered corporate strategy regarding indication expansions on approved drugs and pipeline candidates.
Disease Area: Therapeutics
Drug Type: Biologic
October 4, 2023
Bristol Myers Squibb
Discontinued Research
Princeton, NJ
10,001-50,000 employees
10001-50000 employees
BMS, whose blood thinner Eliquis (apixaban) is also on the list, wrote via email that it, too, is discontinuing certain oncology programs due to the IRA, including a late-stage registration trial for the multiple myeloma drug iberdomide. “Much of our progress against cancer is the result of post-approval research for patients, [and] as a result of the IRA, this research and progress is now at risk,” the BMS spokesperson wrote.
2 Discontinued Research Programs: iberdomide clinical trial; unnamed oncology programs
Disease Area: Oncology
Drug Type: Biologic, Small Molecule
August 14, 2023
Xilio Therapeutics
Negative Outlook
Waltham, MA
51-200 employees
51-200 employees
Disease Area: Oncology
Drug Type: Biologic
August 10, 2023
Zymeworks
Negative Outlook
Middletown, DE
201-500 employees
201-500 employees
Disease Area: Multiple, Oncology, Therapeutics
Drug Type: Biologic
August 9, 2023
Adicet Bio
Negative Outlook
Boston, MA
51-200 employees
51-200 employees
Disease Area: Oncology
Drug Type: Biologic
August 9, 2023
Pfizer
Neutral Outlook
New York, NY
50,001+ employees
50001+ employees
Disease Area: Multiple, Oncology
Drug Type: Biologic, Small Molecule
