The introduction of biosimilars in the treatment of age-related macular degeneration (AMD) is raising concerns among physicians about cost-driven mandates and the autonomy to choose the best therapies for their patients, according to Paul Hahn, MD, PhD, FASRS, a retina specialist at NJ Retina.

A study evaluating pregnancy outcomes and infant developmental milestones found similar outcomes between pregnant women with inflammatory bowel disease (IBD) who received reference infliximab and those who received a biosimilar.

Celltrion and Formycon with Fresenius Kabi launched their respective ustekinumab biosimilars (Steqeyma and Otulfi), joining 4 others that launched earlier this year.

Although more research is needed in pediatric patients, biosimilars could improve treatment access and reduce costs.

The denosumab biosimilar market is poised for disruption with 3 FDA-approved biosimilars, at least 5 awaiting approval, and launches anticipated to start in May 2025, while ongoing patent litigation continues to shape the competitive landscape.

Sarfaraz Niazi, PhD, urges the FDA to let the USPharmacopeia (USP) create product release specifications for biosimilars to cut costs, speed development, and enhance accessibility.

Despite saving billions, biosimilars still account for only a small share of the biologics market—what's standing in the way of broader adoption and how can artificial intelligence (AI) help change that?

Celltrion's Omlyclo (omalizumab-igec) is the first omalizumab biosimilar to be approved for US patients, and it was approved with interchangeability, making it easier for patients to switch to the Xolair competitor.

Since the FDA’s groundbreaking approval of Zarxio in 2015, the US biosimilars market has surged to 67 approvals across 18 originators—though the journey has been anything but smooth, with adoption facing hurdles along the way.

Adalimumab biosimilars differ from adalimumab in approved indications, concentration and dosage, and formulation.

The approvals for Celltrion's denosumab-bmwo (Stoboclo and Osenvelt) mark the third FDA green light for a biosimilar to treat osteoporosis and bone metastases.

A prospective cohort study found that switching back from the biosimilar SB2 to the reference infliximab did not affect clinical disease activity or safety in inflammatory bowel disease (IBD).

February brought policy updates and several biosimilar approvals, including the first FDA approval for an insulin aspart biosimilar.

Patients with non-small cell lung cancer (NSCLC) taking bevacizumab biosimilars demonstrated equivalent therapeutic efficacy and similar safety profiles to those taking the originator product, Avastin.

Patients with inflammatory bowel disease (IBD) who switched from reference adalimumab (Humira) to a biosimilar under a mandatory nonmedical switching policy maintained long-term safety, efficacy, and treatment persistence comparable to those who remained on the originator drug, according to a Canadian study.

The FDA and European Medicines Agency (EMA) mandate high similarity between biosimilars and reference products, but their regulatory processes differ, especially with multiple reference products.

Three ustekinumab biosimilars enter the US market, expanding access to more affordable options referencing Stelara (ustekinumab), one of the most profitable drugs in the world.

On 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.

A 15-year-old girl with ulcerative colitis who developed injection site reactions to the adalimumab reference product was successfully switched to the biosimilar LBAL without recurrence of symptoms, demonstrating the safety and effectiveness of switching for medical reasons, likely due to an allergic reaction to an excipient in the originator.

Celltrion expands its reach in Europe, securing marketing authorization from the European Commission (EC) for its denosumab biosimilar candidate (Stoboclo and Osenvelt) and its aflibercept biosimilar (Eydenzelt).

The FDA and European Medicines Agency (EMA) granted approval, with interchangeability in the US, to Samsung Bioepis' denosumab biosimilars, which will be marketed under different names depending on whether they will be used to treat osteoporosis or bone metastases.

Researchers treated postmenopausal women with osteoporosis with teriparatide biosimilar RGB-10, which improved their bone health measures and reduced fracture risk comparably to reference teriparatide.

The FDA approved Merilog (insulin-aspart-szjj) as the first biosimilar to reference Novolog (insulin aspart) for the treatment of adult and pediatric patients with type 2 diabetes.

Sarfaraz K. Niazi, PhD, gives his opinion on how the recent IQVIA report “Assessing the Biosimilar Void in the US” could be improved for the future.

Switching back from infliximab biosimilar SB2 to reference infliximab (Remicade) did not affect clinical disease activity or safety in inflammatory bowel disease (IBD), according to a prospective cohort study.