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.

Dose escalations were more frequent with ustekinumab in patients with psoriasis compared with adalimumab and etanercept, highlighting varied outcomes for dose optimization in psoriasis management.

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.

Eculizumab biosimilars could provide European patients with paroxysmal nocturnal hemoglobinuria and atypical hemolytic uremic syndrome better access to care for a better price, similar to successes seen in other biosimilar markets, according to a review.

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.

Ivo Abraham, PhD, highlights follow-on biologics as a pathway to a more equitable global health care system by reducing costs and expanding treatment access.

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

Patients with rheumatoid arthritis (RA) who switched from Enbrel (reference etanercept) to a biosimilar maintained remission, even after their dose was reduced, with no signs of worsening based on clinical scores, ultrasound scans, or lab tests, according to a new study.

Australia’s growing reliance on high-cost biologics for inflammatory skin diseases has placed significant pressure on its health system—but a new report suggests biosimilars could offer financial relief, provided uptake barriers are addressed through policy reform and education.

Monthly savings from fully converting Medicare patients with metastatic colorectal cancer (CRC) and non-squamous metastatic non-small cell lung cancer (NSCLC) from reference bevacizumab to bevacizumab-bvzr could fund 13,887 and 8,959 additional patient-months of treatment, respectively, according to a cost-effectiveness study.

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.

Shreehas P. Tambe, MD, highlighted the significant potential for biosimilars to expand into other disease areas like diabetes, offering crucial cost-saving solutions amid a rising global burden of noncommunicable diseases.

To 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."

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.

Christopher T. Robertson, JD, PhD, reviewed the history and ethical landscape of providing access to drugs before FDA approval, highlighting the crucial role of clinical trials and ethical safeguards at the 2025 Festival of Biologics USA.

A plain language summary for patients explains there were no differences in safety outcomes between adalimumab-adbm and the originator in a pooled analysis of the VOLTAIRE clinical trials.

Here are the top 5 biosimilar articles for the week of April 21, 2025.

Sonia T. Oskouei, PharmD, emphasized strategies to streamline regulations and evolve to overcome barriers and expand the availability of cost-effective biosimilar treatments across more therapeutic areas.