Regulatory

FDA approves new denosumab biosimilars, enhancing treatment options for osteoporosis and bone metastases while driving competition and cost savings.

Discover the top 5 regulatory biosimilar news of 2025, highlighting FDA approvals that enhance treatment options and competition in health care.

Biosimilar developers achieve key European approvals for denosumab and golimumab, enhancing patient access while facing US market entry delays.

FDA's new guidance clarifies promotional practices for biosimilars, ensuring accurate marketing and preventing misleading claims in the competitive landscape.

FDA approves multiple denosumab biosimilars, enhancing market access and introducing interchangeability, boosting competition in bone health therapies.

New findings explore the adalimumab biosimilar landscape, focusing on formulation, devices, and patient support programs that enhance treatment experiences.

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

The FDA has approved Celltrion's Eydenzelt, a new aflibercept biosimilar, enhancing treatment options for retinal diseases in the US.

Major advancements in biosimilars emerge in Europe and Middle East and North Africa (MENA) region, enhancing patient access and affordability in critical therapeutic areas.

Recent approvals and settlements enhance global access to aflibercept biosimilars, improving treatment options for age-related macular degeneration and diabetic retinopathy.

The European Commission (EC) approves new biosimilars for osteoporosis and eye conditions, enhancing treatment options and patient access across Europe.

The FDA has approved Bosaya and Aukelso, expanding affordable denosumab biosimilars for osteoporosis and bone-related cancers and enhancing treatment options.

New denosumab biosimilars, Bildyos and Bilprevda, enhance access to affordable osteoporosis and bone disease treatments, promising significant patient benefits.

Patent thickets hinder biosimilar access, driving up costs and delaying affordable treatments. Discover legislative solutions to enhance competition and patient care.

Global regulatory advancements in biosimilars enhance access to affordable treatments for autoimmune disorders, bone diseases, and ophthalmic conditions.

The FDA has approved Kirsty, the first interchangeable insulin aspart biosimilar, enhancing access to affordable diabetes care for millions.

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

FDA approvals for new biosimilars like Starjemza and Hadlima enhance treatment options, addressing urgent needs for affordability and policy reform.

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.

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.

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.

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.