Radar on Specialty Pharmacy

Shortly before Martin Makary, M.D., was sworn in as FDA commissioner on March 28, he was briefed on the plan to push out Center for Biologics Evaluation and Research (CBER) Director Peter Marks, M.D., Ph.D., the agency’s leader of vaccines and cell and gene therapy work, per a former agency official, the Pink Sheet reports.

The news likely will concern industry and other agency stakeholders, including lawmakers, who were banking on Makary trying to keep politics and anti-vaccine sentiment from higher up in the Trump administration out of the agency.

Amid unprecedented turmoil and layoffs at HHS, including the forced resignation of Peter Marks, M.D., Ph.D., director of the FDA’s Center for Biologics Evaluation and Research (CBER) on March 28, the vast majority of biopharmaceutical industry and Wall Street respondents to a Cantor Fitzgerald, L.P., survey are calling for the removal of HHS Secretary Robert F. Kennedy Jr. 

Of the more than 400 respondents, 44% were from biopharma innovators and 40% worked at investment firms. The responses were revealed in an April 7 research note from Cantor biotechnology analysts Josh Schimmer, M.D., and Eric Schmidt, Ph.D.

Directed by the new head of HHS, Robert F. Kennedy Jr., various federal health care agencies recently began implementing sweeping layoffs with the goal of eliminating about 10,000 positions. It’s difficult to understand exactly what the extent of the ramifications will be, but infectious diseases, including HIV and hepatitis, are among the hardest hit areas.

According to the HIV+Hepatitis Policy Institute, layoffs included the entire staff of the HHS Office of Infectious Diseases & HIV Policy and the HHS Office of Minority Health, the policy and data division supporting the Health Resources & Services Administration’s Ryan White HIV/AIDS Program and hundreds of employees at HRSA’s Bureau of Primary Health Care.

A new combination treatment recently gained FDA approval for use in a very small population of cancer patients that has dismal survival rates. Oncologist respondents to a Zitter Insights survey said they believe the treatment will have at least some impact on their prescribing.

On Jan. 16, the FDA gave another approval to Amgen Inc.’s Lumakras (sotorasib), this time in combination with the company’s Vectibix (panitumumab), for the treatment of adults with KRAS G12C-mutated metastatic colorectal cancer (CRC), as determined by an FDA-approved test, who have received fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapy.

It wasn’t until five years after then-President Barack Obama signed the Affordable Care Act (ACA) into law on March 23, 2010, establishing the 351(k) biosimilar pathway via the Biologics Price Competition and Innovation Act (BPCIA), that the FDA approved the first biosimilar. Although the market started slowly and still experiences challenges in getting uptake of these agents, biosimilars have saved the U.S. health care system billions of dollars, observes Cardinal Health in its new report, 10 Years of Biosimilars: 2015–2025.

The FDA approved the first biosimilar, Sandoz’s Zarxio (filgrastim-sndz), on March 6, 2015. The biosimilar of Amgen Inc.’s Neupogen (filgrastim) was the only one of its kind to gain approval that year, followed by three more the following year. Single-digit approvals would follow until 2019, which had 10 approvals, but then 2020 had only three. 2024, however, saw 19 biosimilar approvals, and with the nine as of early April 2025, the FDA had given its blessing to 73 of the agents, representing almost 20 molecules.