In 2019 the FDA approved 48 novel drugs and 10 biosimilars, according to the Center for Drug Evaluation and Research (CDER).
The FDA highlighted biosimilar approvals in its annual report of 2019 drug approvals released this week.
In 2019 the FDA approved 48 novel drugs and 10 biosimilars, according to the Center for Drug Evaluation and Research.
The biosimilar approvals “will further help to create competition, increase patient access, and potentially reduce the cost of important biological drug therapies,” the FDA said.
The 10 biosimilar approvals span indications for rheumatoid arthritis, plaque psoriasis, breast cancer, metastatic stomach cancer, metastatic colorectal cancer, non-squamous non-small cell lung cancer, glioblastoma, metastatic renal cell carcinoma, cervical cancer, B-cell non-Hodgkin’s lymphoma, chronic lymphocytic leukemia, granulomatosis with polyangiitis, and microscopic polyangiitis.
The approvals include:
CDER has now approved a total of 26 biosimilars for 9 different reference products since 2015. In 2018 the FDA approved 59 novel drugs.
Escaping the Void: All Things Biosimilars With Craig & G
May 4th 2025To close out the Festival of Biologics, Craig Burton and Giuseppe Randazzo from the Association for Accessible Medicines and the Biosimilars Council tackle the current biosimilar landscape and how the industry can emerge from the "biosimilar void."
Infliximab Biosimilar Switch Due to Flare Risk: Monitoring Patients Is Crucial for Pharmacists
June 5th 2025Switching from reference infliximab to biosimilars (infliximab-abda and infliximab-dyyb) for rheumatic diseases may lead to treatment delays and a higher risk of disease flares, particularly when the switch is mandated by insurance.
Will the FTC Be More PBM-Friendly Under a Second Trump Administration?
February 23rd 2025On this episode of Not So Different, we explore the Federal Trade Commission’s (FTC) second interim report on pharmacy benefit managers (PBMs) with Joe Wisniewski from Turquoise Health, discussing key issues like preferential reimbursement, drug pricing transparency, biosimilars, shifting regulations, and how a second Trump administration could reshape PBM practices.
Eye on Pharma: Interchangeability Labels and Expanded Biosimilar Partnerships
May 29th 2025The FDA designates 2 biosimilars as interchangeable, enhancing access to treatments for inflammatory diseases and multiple sclerosis, while 2 other companies expand their biosimilar partnership to include more products.
British Columbia’s Biosimilar Policy Shows No Impact on Hospital Visits
May 28th 2025Despite a dramatic shift toward biosimilar use following British Columbia’s policy, researchers found no rise in hospital visits or complications, underscoring the real-world reliability of etanercept biosimilars in managing inflammatory arthritis.