FDA Moves Bring Total Biosimilar Approvals to 54

With the FDA’s approval of three biosimilars in May, that brings the total number of these drugs to 54 since the agency’s green lighting of Sandoz’s Zarxio (filgrastim-sndz) on March 6, 2015. With all three agents also gaining interchangeability status, that brings the count to 14 biosimilars with this designation. Payer and provider respondents to a Zitter Insights survey said they expect to see increased use in rheumatoid arthritis (RA) and ophthalmic biosimilars, among others, this year, while oncologists cited agents for non-small cell lung cancer (NSCLC) as the area in which they expected to see the most increase.

On May 20, the FDA approved the first biosimilars of Regeneron Pharmaceuticals, Inc.’s Eylea (aflibercept): Biocon Ltd. subsidiary Biocon Biologics Ltd.’s Yesafili (aflibercept-jbvf) and Samsung Bioepis Co., Ltd. and Biogen Inc.’s Opuviz (aflibercept-yszy).

The vascular endothelial growth factor (VEGF) inhibitors were approved for four of Eylea’s five indications: the treatment of neovascular (wet) age-related macular degeneration (AMD), macular edema following retinal vein occlusion (RVO), diabetic macular edema (DME) and diabetic retinopathy (DR). Retinopathy of prematurity (ROP) is the only condition that the agents were not approved for; Eylea gained approval for it on Feb. 8, 2023.

Barely more than a week later, on May 28, the FDA OK’d the first biosimilar of Alexion, AstraZeneca Rare Disease’s, Soliris (eculizumab): Amgen Inc.’s Bkemv (eculizumab-aeeb). The interchangeable complement 5 inhibitor was approved for the treatment of people with paroxysmal nocturnal hemoglobinuria (PNH) to reduce hemolysis and people with atypical hemolytic uremic syndrome (aHUS) to inhibit complement-mediated thrombotic microangiopathy.

Soliris also has approval for the treatment of generalized myasthenia gravis (gMG) in adults who are anti-acetylcholine receptor (AChR) antibody positive and the treatment of neuromyelitis optica spectrum disorder (NMOSD) in adults who are anti-aquaporin-4 (AQP4) antibody positive.

It is unclear when the Eylea biosimilars will be available, as both are involved in patent litigation brought by Regeneron. Amgen also was involved in patent litigation with Alexion, but a settlement agreement allows Bkemv to launch March 1, 2025, or an earlier date in certain circumstances.

For the Managed Care Biologics & Injectables Index: Q3 2023, from Aug. 13, 2023, to Sept. 18, 2023, Zitter Insights polled 35 commercial payers covering 117.5 million lives, 27 Medicare payers covering 43.6 million lives, 103 physicians and 63 oncologists about biosimilar trends. Payers with 14% of commercial lives said they had seen savings due to biosimilar use, with RA, neutropenia, ophthalmic and breast cancer agents being the top areas.

AIS Health and Zitter Insights are both divisions of MMIT.

Based on the percent of covered lives, commercial payers said RA, ophthalmic, breast cancer and diabetes biosimilars were the top therapeutic classes they expected to increase their use of within the 12 months following the survey (see chart). Those respondents said that they expected biosimilars for gastric cancer and chronic lymphocytic leukemia to have the least increase in utilization.

Meanwhile, 62% of physician respondents said they had prescribed biosimilars within the past six to 12 months. The top indication for which they were prescribing was RA, followed by neutropenia, diabetes and ophthalmic. And 79% of oncologists had prescribed a biosimilar during that same time frame, with the most prescriptions for breast cancer, followed by colorectal cancer, neutropenia and non-Hodgkin’s lymphoma.