Business

Biosimilar partnerships and EU approvals surge, enhancing access to innovative treatments in immunology, oncology, and bone health markets.

The latest advancements in global biosimilar access include new treatments, strategic partnerships, and competitive market entries enhancing patient care.

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.

Alvotech achieves a remarkable financial turnaround in 2025, reporting a net profit driven by strong biosimilar sales and strategic partnerships.

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.

Biosimilar insulin glargine struggles for market share in the UK, facing pricing challenges and prescriber inertia despite regulatory support and cost-saving potential.

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.

Alvotech and Dr. Reddy's partner to develop a Keytruda biosimilar, a German court bans Humira biosimilar over patent dispute, and Samsung Bioepis enters a strategic agreement with NIPRO Corporation in Japan.

Leading biosimilar companies Sandoz, STADA Arzneimittel, and Samsung Bioepis report impressive Q1 2025 growth, driven by strong denosumab biosimilars and expanding portfolios.

Patent settlements accelerate the entry of generics and biosimilars, saving the health care system $422.9 billion and enhancing drug accessibility.

Denosumab biosimilars Wyost and Jubbonti launch in the US, enhancing access to affordable treatments for osteoporosis and cancer-related skeletal events.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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

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 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.

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.