IRA fix would boost biosimilars

New bill would fix IRA to encourage biosimilar innovation

New legislation introduced in the House would encourage development of biosimilars by fixing a loophole in the Inflation Reduction Act (IRA).

The Biosimilar Access and Affordability Act, introduced in the House Oct. 2, facilitates delay of IRA price “negotiation” for biologic drugs if a biosimilar competitor is expected to enter the market in two years. IRA recognizes the need for this delay, but the current provision has been implemented ineffectively.

Why it matters: When IRA price controls cut the price of a biologic, that also reduces potential revenues a biosimilar competitor can hope to earn. Biosimilar developers and investors lose incentive to commercialize treatments that would ultimately increase affordability and patient access.

Bipartisan support: Introduced by Rep. Nick Langworthy (R-NY), the bill is co-led by Reps. Jake Auchincloss (D-MA), John Joyce (R-PA), Linda Sánchez (D-CA), Scott Peters (D-CA), Rudy Yakym (R-IN), and Nathaniel Moran (R-TX), and co-sponsored by Reps. Kevin Mullin (D-CA) and Jimmy Panetta (D-CA). Sen. Marsha Blackburn (R-TN) introduced the Senate version.

What they’re saying: "For people managing a rare disease, access isn't abstract,” says Sarah Jones of the Eosinophilic Rare Disease Coalition. “Biosimilars are an important part of the treatment landscape, and we should prioritize access to all treatment options."

BIO's view: "The Inflation Reduction Act continues to adversely affect many areas of drug development—be it emerging biotechs seeking their first product launch or biosimilar competition," says Aiken Hackett, BIO EVP of Federal Government Relations. "BIO supports targeted IRA reforms, including the bipartisan-bicameral Biosimilars Access and Affordability Act and other efforts to reduce barriers and spur innovation.”

Record measles outbreaks highlight need for combined MMR vaccine

Measles outbreaks around the U.S., including a deadly record-level outbreak in Pennsylvania, encourage uptake of the CDC-recommended combined measles, mumps, rubella (MMR) vaccine.

Latest outbreaks: As of Oct. 7, Pennsylvania recorded five measles-related deaths and 1,136 cases this year—157 in the previous seven days. No state has reported more than 1,000 cases since 1991, before America eliminated measles. In New York, after 108 cases this year, Gov. Katy Hochul declared an emergency on Oct. 5.

The national picture: The 4,080 U.S. measles cases reported by the Centers for Disease Control and Prevention (CDC) as of Oct. 9 represent the highest number since 1991, and 95% of those cases are among the unvaccinated or those with unknown vaccination status.

Why it matters: Measles was eliminated in the U.S. by widespread vaccination. The MMR vaccine has been the preferred shot since 1971, and it also led to huge drops in mumps and rubella.

CDC recommends protectionwith the MMR vaccine. In response to the outbreak, Pennsylvania reportedly administered over 53,000 MMR vaccines in September, more than double the usual monthly total.

BIO explains benefits of combination vaccines like MMR: “Easier on children and families—fewer needles, fewer visits,” says BIO’s fact sheet. “Combination vaccines are a product of decades of U.S. biotech research and the preferred, proven choice of doctors and parents for protecting children safely and simply.” Read more here.

What Else to Read

ACIP should remain the body responsible for making vaccine recommendations, and its recommendation categories do not need to be changed, BIO tells the Department of Health and Human Services (HHS). In response to a request for information (RFI), BIO recommended against external restructuring of Advisory Committee on Immunization Practices (ACIP) vaccine recommendation categories. “The current vaccine recommendation categories were developed to translate ACIP’s scientific assessment into clear clinical guidance,” BIO’s comments say. “The categories were not intended to signal different standards of evidence or different levels of confidence in vaccine safety and effectiveness.” Read more on Bio.News.

BIO Chief Patient Advocate Michele Oshman highlighted the importance of the Pediatric Priority Review Voucher (PPRV) in her keynote for the Rare Trials Summit. Along with 10-year-old Maggie Dion, who was born with limb-girdle muscular dystrophy, and her parents, Joe and Courtney Dion, Oshman explained how the PPRV incentivizes research into rare diseases affecting children. She also discussed the need to enable more clinical trials for rare disease. “These trials aren’t getting stalled because the medicine’s not working, but because of the financing,” Oshman said. Read more on Bio.News.

Annetta Beauregard, BIO SVP of Science and Regulatory Affairs, joined Food and Drug Administration (FDA) Center Directors Karim Mikhail (CBER) and Dr. Mike Davis (CDER), and other experts at the Alliance for a Stronger FDA's Oct. 1 "Supporting the FDA of Tomorrow" summit. Beauregard joined the panel entitled "Modernizing Drug and Biological Drug Development and Review." She explained the value of FDA and industry collaboration on key policies, including Prescription Drug User Fee Act (PDUFA) commitments, and highlighted opportunities to advance early drug development efficiency in the U.S. Read more here.

Florida holds public hearing on a plan to reduce the number of vaccines required of students entering school. “Under the proposal, hepatitis B, varicella, haemophilus influenzae type b (Hib) and pneumococcal conjugate vaccines would no longer be required as part of school and child care entry requirements established through Department rule,” said an announcement from the Florida Department of Health about the Oct. 8 hearing. The Florida Department of Health is still accepting comments on the rule proposal by email at vaccinerule@flhealth.gov until 5pm on Oct. 19. Read more here.

Study finds steep decline in shingles among younger U.S. adults due to chickenpox vaccination beginning in 1995. As the first generation eligible for routine childhood chickenpox vaccination reaches adulthood, they are seeing much lower levels of shingles, according to a study of 85 million health records in the U.S. Shingles, or herpes zoster, is a painful rash caused by reactivation of the varicella-zoster virus, which causes chickenpox, and the chickenpox vaccine is dramatically reducing shingles infection, according to the study by Epic Research. Read more here.

Sen. Dave McCormick (R-PA) promotes the importance of National Institutes of Health (NIH) grants in a Washington Post opinion column. "Federal research and private enterprise made American medicine the envy of the world, and artificial intelligence is accelerating discovery like never before. Yet at the most exciting moment in medical history, I fear the United States will surrender its lead to China through underinvestment and mismanagement," he writes. "This summer, the White House rightly called for a new golden age of American science. Reaching it requires long overdue reform and more investment in federal research and development." Read more here.

AstraZeneca will open a new global strategic R&D centre in Cambridge, MA. Built with a $1 billion investment, the 18-floor building at 290 Binney St. joins the firm’s site for genomic medicine at 100 Binney St. on Kendall Square, “the heart of one of the world’s most innovative life sciences ecosystems,” AstraZeneca said. Together, the two sites “will be home to nearly 2,000 world-class researchers and scientists who will accelerate the company’s oncology, cell therapy, chronic disease and rare disease pipeline to deliver transformative medicines of the future.” Read more here.

Beltway Report

Both the House and Senate are back home campaigning through the election. They will return the week of Nov. 9.