News

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.

Sophia Humphreys, PharmD, MHA, BCBBS, emphasized that legislative support and formulary changes are crucial for overcoming unique challenges in specialty pharmacies and driving the growth of biosimilar adoption, which has significant cost saving potential in the next decade.

Dracey Poore, MS, director of biosimilars and emerging therapies at Cardinal Health, highlighted that biosimilars saved $36 billion over the last decade by improving patient access and the supply chain, but continued education and a robust pipeline are crucial for future growth.

Biosimilars are proving to be a game-changing solution in the fight against inflammatory bowel disease (IBD), offering a cost-effective alternative to biologics with similar efficacy and safety, while innovative drug delivery systems promise to further enhance treatment outcomes and accessibility for millions worldwide.

Sandoz's antitrust suit against Amgen, the FDA’s interchangeability designation for Celltrion’s adalimumab biosimilar, and the inclusion of an ustekinumab biosimilar in Costco’s prescription program highlight growing momentum to expand biosimilar access and affordability for patients with chronic inflammatory diseases.

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.

A retrospective study from a single inflammatory bowel disease (IBD) center in Greece reported that from 2018 to 2022, the use of biologics increased by 28% yearly, and the proportion of patients using biosimilars grew from 33% to 67%.

Here are the top 5 biosimilar articles for the week of April 14, 2025.

Trastuzumab biosimilars saw significant market uptake in Japan after reimbursement incentives were implemented, but bevacizumab biosimilars did not experience a similar response.

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.

During Q1 2025, pharmaceutical companies accelerated biosimilar expansion through strategic acquisitions and partnerships in hopes of boosting patient access to lower-cost treatments in immunology and oncology.

Elena Wolff-Holz, MD, global head of clinical development at Biocon Biologics, discussed the approval of BMAb-1200, a biosimilar to reference ustekinumab for psoriasis, highlighting comparable efficacy and safety data while noting challenges in global patient recruitment and regulatory navigation.

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.

Here are the top 5 biosimilar articles for the week of April 7, 2025.

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

Teva and Samsung Bioepis have launched Epysqli, a cost-saving Soliris biosimilar, offering a 30% discount and new hope for patients with rare, life-threatening hematologic conditions.

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.

Early market entry, manufacturing efficiency, and market share are critical to biosimilar development success, while technical complexity and competition heavily impact returns, according to a study presenting a risk-adjusted net present value (NPV) analysis framework.

High adherence rates, comparable clinical effectiveness, and cost savings have marked the early adoption of adalimumab biosimilars in the US, particularly in formulary-driven transitions, as shown in 2 retrospective studies presented at the Academy of Managed Care Pharmacy annual meeting (AMCP 2025).

Here are the top 5 biosimilar articles for the week of March 31, 2025.

The ranibizumab biosimilar Ongavia exhibited significantly less improvement in visual acuity and retinal thickness compared with aflibercept (Eylea) in treating neovascular age-related macular degeneration (nAMD), highlighting a potential trade-off between economic savings and clinical efficacy.

Bevacizumab biosimilars Mvasi and Zirabev provided cost savings for metastatic colorectal cancer (mCRC) treatment without compromising effectiveness.

As the biosimilar industry celebrates a decade of growth, the market continues to evolve with expanded treatment options, cost savings, and a flurry of new competitors—yet regulatory challenges, market dynamics, and patient accessibility remain key hurdles to unlocking its full potential.

Alvotech's 427% revenue surge in 2024—fueled by its biosimilar portfolio and global expansion—highlights the booming profitability of biosimilars despite financial hurdles.

Josh Canavan, PharmD, RazorMetrics, and Chris O'Dell, Turquoise Health, predict pharmacy benefit managers (PBMs) will evolve toward value-based care, mirroring the broader shift toward open-cost structures.