Development

FDA's new guidance streamlines biosimilar development, reducing costs and regulatory hurdles and potentially enhancing market access and affordability.

Biosimilars revolutionize health care access in Latin America, offering cost savings and improved treatment availability for chronic conditions and oncology.

AVT06, a promising biosimilar to aflibercept (Eylea), shows comparable efficacy and safety for treating neovascular age-related macular degeneration (AMD), enhancing patient access.

Omalizumab biosimilars promise significant savings for European health systems, enhancing access to vital therapies for patients with severe allergies.

Biosimilars and generics drive significant health care savings, yet a concerning lack of biosimilar development for biologics set to lose exclusivity in the next 10 years threatens future access and affordability.

A 10-year prospective follow-up of 244 healthy stem cell donors found no new safety concerns with Sandoz’s filgrastim biosimilar, reinforcing its long-term safety for donor mobilization.

Explore groundbreaking developments in biosimilars, including patent lawsuits, new ustekinumab launches, and innovative access strategies for patients.

Government price negotiations under the Inflation Reduction Act may hinder biosimilar development, impacting drug costs and patient access to affordable therapies.

Biosimilars face a potential void as biologics lose exclusivity, prompting urgent calls for policy reform and enhanced education to ensure market sustainability.

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

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.

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.

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.

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

Monoclonal antibodies lead biosimilar approvals because of their large market size, well-defined regulatory pathways, and technological feasibility, whereas other biologics encounter development challenges but may see increased adoption as regulatory frameworks advance.

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.

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.

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.

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.

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.

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.

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.

Eculizumab biosimilar Elizaria demonstrates long-term safety and efficacy comparable with the reference product Soliris in patients with paroxysmal nocturnal hemoglobinuria (PNH), according to a Russian study that expanded on a previous phase 3 study.

Biosimilar teriparatide has been shown to be as safe and effective as its reference product for osteoporosis treatment, potentially enabling significant cost savings in Japan’s health care system while addressing persistent misconceptions about biosimilar quality.

Sarfaraz K. Niazi, PhD, dives into the role that biosimilar associations and organizations play in promoting biosimilars as well as how their stakeholder demographic and main objectives differ from one another.