On Tuesday, Congress passed bipartisan reforms to Q1/Q2 sameness requirements
as part of a broader government funding package.





 

February 6, 2026



TOPLINE



On Tuesday, Congress passed bipartisan reforms to Q1/Q2 sameness requirements
as part of a broader government funding package. These solutions will bring
greater transparency to the generic drug approval process and promote stronger
competition from more affordable alternatives to high-priced brand-name
medications. The legislation was signed into law by the president on Wednesday.
Read moreHERE
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.



Also, last week, brand name manufacturer Sanofi reported
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earnings that surpassed Wall Street analysts’ expectations, increasing their
guidance for 2026. The Big Pharma company reported the blockbuster earnings
after hiking drug prices for American patients throughout 2025 – and to start
the year.



During Sanofi’s fourth quarter earnings call
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, Houman Ashrafian, Head of Research and Development at Sanofi touted the
company’s extensive patent strategy around blockbuster eczema and asthma
treatment Dupixent, “We do expect Dupixent to be protected by its patents
beyond March 2031 in the U.S…We believe we have a very strong patent portfolio,
which we intend to vigorously defend.”



Sanofi’s eagerness to game the patent system to block and delay competition to
Dupixent will be costly for American patients and taxpayers. For example,
Medicare Part D spending on specialty brand name drugs like Dupixent has
dramatically increased, while manufacturers have continued hiking prices.



According to a 2025 study
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published in JAMA Dermatology, conducted by researchers affiliated with Harvard
Medical School and Brigham and Women’s Hospital, “inflation-adjusted Medicare
Part D spending increased… from $768 million in 2013 to $2.95 billion in 2022,”
with specialty prescription drugs, like Dupixent, driving “98.4% of this
growth, increasing from 30.8% of all dermatology drug spending in 2013 to 80.9%
in 2022, despite being only 2.9% of prescriptions.”



Read more on the fourth quarter earnings from Sanofi HERE
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QUOTE OF THE WEEK



“CSRxP applauds Congress for advancing bipartisan reforms to prevent Big
Pharma from gaming Q1/Q2 requirements to delay competition and keep
prescription drug prices high. CSRxP has been a longstanding supporter of this
market-based solution that will bring greater transparency to the generic drug
approval process and promote stronger competition from more affordable
alternatives to high-priced brand-name medications. We look forward to it being
signed into law by the president.”



Lauren Aronson, executive director, CSRxP
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DATA POINTS YOU SHOULD KNOW



122 Percent



The increase in revenue
<[link removed]> Zepbound,
Eli Lilly’s blockbuster GLP-1 drug, brought in for the Big Pharma giant in Q4
of 2025



TWEETS OF THE WEEK



@P4ADNOW <[link removed]>: “By abusing the
patent system, big drug companies keep generic and biosimilar competition off
the market, increasing their own profits, and keep prices high for patients.
Learn how patients are fighting back athttp://PatientsPushForCompetition.org
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@CAPPA_Rx <[link removed]>: “For Big
Pharma, one lawsuit isn’t enough. When a generic manufacturer tries to enter
the market, brand-name drug companies often file multiple patent lawsuits over
the same drug — one after another.”



ROAD TO RECOVERY



Bloomberg Government: PhRMA, PCMA Asked to Testify Before Health Panel
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CEOs and leaders of top drug supply chain organizations—including PhRMA—are
being asked to testify before the House Energy and Commerce panel on Feb. 11.
PhRMA Chief Operating Officer, Lori Reilly, is being asked to testify before
the committee, according to a person familiar with the committee’s request… One
group noted that PhRMA is not sending its CEO to the hearing. “It is remarkably
telling that CEOs from every other sector of the prescription drug supply chain
are confident appearing and answering questions on affordability from
lawmakers, except for PhRMA,” said Jon Conradi, spokesman for the Campaign for
Sustainable Rx Pricing.



The Washington Post: Next Up for Congress: Pharma Execs
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The House is turning its attention to the pharmaceutical industry as it
tackles the issue of health care affordability in an election year — calling
executives to testify about the “root” causes of drug prices next Wednesday.



PHARMA’S POOR PROGNOSIS



Fierce Pharma: Sanofi Sanctioned By PMCPA Over CEO's 'Bold Claims' About
Pfizer RSV Vaccine
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A U.K. marketing watchdog has sanctioned Sanofi after ruling its CEO Paul
Hudson may have undermined the U.K. government’s vaccine program by making
“bold claims” about a procurement choice. Pfizer triggered the investigation by
contacting the PMCPA about an article the Observer newspaper ran in 2024. In
it, Hudson was quoted as saying Beyfortus, Sanofi’s respiratory syncytial virus
(RSV) product, should be considered instead of Pfizer’s vaccine Abrysvo.



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