Radar on Specialty Pharmacy

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.

March 17: The FDA approved Zydus Lifesciences Limited’s apalutamide 60 mg tablets for the treatment of people with metastatic castration-sensitive prostate cancer. The androgen receptor inhibitor is the first FDA-approved generic of Johnson & Johnson’s Erleada. Dosing of the tablet is 240 mg once daily. Erleada also is approved for the treatment of nonmetastatic castration-resistant prostate cancer, as well as a 240 mg tablet. Drugs.com lists the price of 120 60 mg tablets and 30 240 mg tablets of Erleada as more than $15,982.

March 19: The FDA granted traditional approval to Merck & Co., Inc.’s Keytruda (pembrolizumab) in combination with trastuzumab, fluoropyrimidine- and platinum-containing chemotherapy for the first-line treatment of adults with locally advanced unresectable or metastatic human epidermal growth factor receptor 2 (HER2)-positive gastric or gastroesophageal junction adenocarcinoma whose tumors express programmed death-ligand 1 (PD-L1) as determined by an FDA-approved test. The agency gave the programmed death receptor-1 (PD-1) inhibitor accelerated approval for this indication on May 5, 2021; the drug’s first approval overall was Sept. 4, 2014. This application has orphan drug designation, and its review used the Assessment Aid. Dosing for this use is 200 mg every three weeks or 400 mg every six weeks. The list price for every-three-weeks dosing is $11,564.16; every-six-weeks dosing is $23,138.32.

Two biosimilars of Alexion, AstraZeneca Rare Disease’s Soliris (eculizumab) are now available. Amgen Inc.’s interchangeable Bkemv (eculizumab-aeeb) launched in early March, and Epysqli (eculizumab-aagh) from Teva Pharmaceutical Industries Ltd.’s Teva Pharmaceuticals and Samsung Bioepis Co., Ltd. became available in early April. The FDA approved Bkemv on May 28, 2024, and Epysqli on July 19, 2024. The agents are approved to treat paroxysmal nocturnal hemoglobinuria (PNH) to reduce hemolysis, atypical hemolytic uremic syndrome (aHUS) to inhibit complement-mediated thrombotic microangiopathy and generalized myasthenia gravis (gMG) in adults who are anti-acetylcholine receptor (AchR) antibody positive. Soliris also is approved to treat gMG in pediatric patients at least 6 years old and neuromyelitis optica spectrum disorder (NMOSD) in adults who are anti-aquaporin-4 (AQP4) antibody positive. The wholesale acquisition cost of a single-dose vial of Soliris is $6,523. Bkemv’s WAC is more than $5,870 for a single-dose vial, about 10% below Soliris’ price, and Epysqli’s is $4,566, a 30% discount off Soliris’ WAC.

As expected, multiple biosimilars of Stelara (ustekinumab) from Johnson & Johnson Innovative Medicine (formerly Janssen Biotech, Inc.) launched onto the U.S. market in February, offering significant discounts off the reference drug’s list price.

As of mid-March, the FDA has approved seven biosimilars of Stelara for all of the reference drug’s indications: the treatment of adults and pediatric patients at least 6 years old with moderate-to-severe plaque psoriasis who are candidates for phototherapy or systemic therapy, adults and pediatric patients at least 6 years old with active psoriatic arthritis, adults with moderately to severely active Crohn’s disease and adults with moderately to severely active ulcerative colitis.

The FDA recently approved a new antibody-drug conjugate (ADC) for the treatment of the most common form of breast cancer. The treatment offers a new option for a disease with less-than-impressive survival rates. While payers expect it to have some impact in their management of the condition, oncologists said they anticipate it having more of an impact on their prescribing, according to a Zitter Insights survey.

On Jan. 17, the FDA approved Daiichi Sankyo, Inc. and AstraZeneca’s Datroway (datopotamab deruxtecan-dlnk or Dato DXd) for the treatment of adults with unresectable or metastatic hormone receptor positive (HR+), human epidermal growth factor receptor 2 negative (HER2-) breast cancer who have received endocrine-based therapy and chemotherapy for unresectable or metastatic disease. The agency gave the drug breakthrough therapy designation and priority review, which used the Assessment Aid for the Trop-2-directed antibody and topoisomerase inhibitor conjugate. The recommended dose is 6 mg/kg via intravenous infusion every three weeks, and the price of one 100 mg single-dose vial is $4,891.07.