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Here are the top 5 biosimilar articles for the week of February 24, 2025.

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.

Here are the top 5 biosimilar articles for the week of February 17, 2025.

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.

Travis Brewer, vice president of payer and public health strategy at Texas Oncology, discusses the role of biosimilars in making cancer care more affordable and accessible, as well as the need for greater payer trust in oncologists’ treatment decisions.

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.

Although Lantus continues to lead the insulin glargine market globally, the rise of biosimilars like Abasaglar and Semglee has sparked significant price reductions, with some European countries seeing discounts of up to 42.3%.

Here are the top 5 biosimilar articles for the week of February 10, 2025.

The Senate voted 52-48 to confirm Robert F. Kennedy Jr as secretary of HHS, setting up the vaccine skeptic to carry out major changes in pursuit of his Make America Healthy Again agenda.

The Department of Veterans Affairs (VA) saved $67 million in 2023 through its strong adoption of biosimilars to curb the high costs of biologic therapies to treat chronic disease.

The pharmaceutical landscape enters 2025 with a mix of challenges and opportunities, with the potential to shape the future of drug access and affordability for patients across the nation.

2025 marks a pivotal year for biosimilars with Amgen's Wezlana leading ustekinumab biosimilar launches, potentially driving savings and access, as highlighted by Dracey Poore, MS, of Cardinal Health.

In this episode of Not So Different, host Skylar Jeremias covers the latest biosimilar developments, including new FDA approvals, patent disputes, and biosimilar market trends shaping the health care landscape.

A retrospective observational study found no significant differences in progression-free survival or safety in patients with colorectal cancers in Japan treated with ABP 215, Amgen’s bevacizumab biosimilar, or reference bevacizumab (Avastin), and estimated cost savings of 800,000 Japanese yen (approximately $5100) per patient with the biosimilar.

Here are the top 5 biosimilar articles for the week of February 3, 2025.

The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) recommended 3 biosimilars and new indications for reference biologics, moving them closer to final European approval and expanding patient access.

Enzeevu (aflibercept-abzv), a biosimilar developed by Sandoz, demonstrated biosimilarity to reference aflibercept (Eylea) in patients with neovascular age-related macular degeneration (nAMD).

Of the 118 biologics losing exclusivity over the next decade, only 10% have biosimilars in development, meaning a vast majority of biologics have no pipeline, which limits savings potential for the health care system.

Biosimilars have the potential to reduce health care costs and expand patient access, but economic and policy barriers affect adoption, explored James D. Chambers, PhD, MPharm, MSc, associate professor at the Tufts Medical Center Institute for Clinical Research and Health Policy Studies, in an interview.

Sarfaraz K. Niazi, PhD, argues that regulatory agencies should eliminate redundant clinical efficacy testing for biosimilars, recognizing them as "biogenerics" since physicochemical and in vitro biological comparisons are sufficient to ensure safety and efficacy.

Josh Canavan, PharmD, head of pharmacy at RazorMetrics, recommends key educational resources for biosimilars, and emphasizes the extensive research conducted before pharmacy benefit managers (PBMs) add medications, including biosimilars, to their formularies.