Policy

A recent review confirms the safety and efficacy of biosimilar insulins, addressing concerns and promoting their adoption for diabetes treatment.

The debate over the Biosimilar Red Tape Elimination Act raises critical concerns about FDA standards, physician trust, and patient safety in biosimilars.

Celltrion's FDA approval of Steqeyma enhances pediatric psoriasis treatment, offering flexible dosing options for children with chronic inflammatory conditions.

The new data were collected to fulfill the FDA's requirements to designate adalimumab-fkjp (Hulio) as interchangeable with Humira, enhancing access to affordable biologics for chronic plaque psoriasis treatment.

Biosimilar associations advocate for lower development costs and streamlined regulations to enhance patient access to affordable biosimilars.

The 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.

Despite 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.

Starjemza gains FDA approval as the eighth ustekinumab biosimilar, enhancing treatment options for rheumatic and gastrointestinal conditions.

There's a need for early anti-tumor necrosis factor (TNF) therapy in inflammatory bowel disease (IBD), with new data showing that biosimilars can address cost barriers and enhance patient access and outcomes.

Despite the clear promise of cost savings and expanded access, the path to integrating generics and biosimilars across the Middle East and North Africa (MENA) region is tangled in a web of distrust, inconsistent policies, and deep-rooted cultural preferences for branded drugs.

While the Trump administration’s latest executive order touts sweeping drug price cuts through international benchmarking, the broader pharmaceutical pricing crisis in the US reveals a far more complex web of development costs, profit incentives, and absent price controls—raising the question of whether any single policy, including potential drug tariffs, can truly untangle it.

Cimerli offers a promising biosimilar treatment for age-related macular degeneration, enhancing vision preservation with its effective vascular endothelial growth factor inhibition.

Incentivizing physicians with modest financial bonuses may seem like a small step, but in Japan’s outpatient oncology setting, it helped push trastuzumab biosimilars toward broader adoption, demonstrating how even limited reimbursement reforms can reshape prescribing behavior under the right conditions.

A wave of biosimilar approvals, aggressive pricing strategies, and a regulatory sea change are setting the stage for unprecedented momentum in the US biologics market, with 2025 already proving to be a landmark year in reshaping cost, access, and innovation across therapeutic areas.

Between congressional hearings and executive orders, experts had plenty to draw on when dissecting the barriers to biosimilar access at Festival of Biologics USA to close out April 2025.

Thriving in the evolving biosimilar market demands bold collaboration, early global partnerships, and a fresh approach to development strategies to overcome uncertainty and drive future success.

Sarfaraz K. Niazi, PhD, shares his latest citizen's petition to the FDA, calling on the agency to waive clinical efficacy testing in response to the European Medicines Agency's (EMA) efforts towards the same goal.

To help bring down sky-high drug prices, President Donald Trump signed an executive order pushing for faster biosimilar development, more transparency, and tougher rules on pharmacy benefit managers—aiming to save billions and make meds more affordable for everyone.

States with fewer restrictions on biosimilar substitution tend to see higher uptake of interchangeable insulin glargine, showing how even small policy details can significantly influence biosimilar adoption and expand access to more affordable insulin.

Lawmakers and expert witnesses emphasized the potential of biosimilars to lower health care costs by overcoming barriers like pharmacy benefit manager practices, limited awareness, and regulatory delays to improve access and competition in chronic disease management during a recent congressional hearing.

Biocon Biologics expands its oncology biosimilar roster after gaining FDA approval for Jobevne (bevacizumab-nwgd), the sixth biosimilar referencing Avastin (bevacizumab).

Affirming that analytical characterization is often sufficient for biosimilar approval, minimizing unnecessary clinical testing, and enhancing FDA-led education to counter stakeholder misconceptions are key recommendations put forth in this opinion piece by Sarfaraz K. Niazi, PhD.

Switching between adalimumab products does not affect drug effectiveness or treatment duration in patients who have psoriasis, according to a Danish study.

Tendering emerged as the most effective strategy for reducing costs and increasing biosimilar uptake in the retail setting, while price-linked discounts and prescribing quotas have shown mixed or uncertain results.

Global biosimilar regulatory harmonization will be needed to reduce development costs and improve patient access, despite challenges posed by differing national requirements and regulatory frameworks, according to review authors.

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.

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.