Regulatory

Sandoz moves toward US generic tirzepatide autoinjectors as FDA reviews ANDAs, signaling future GLP‑1 access amid patent and biosimilar gaps.

FDA expands Tofidence uses, Teva launches Eylea biosimilar in Europe, and Alvotech’s Entyvio rival enters FDA review—boosting access.

Global review reveals uneven biosimilar rules on waivers, interchangeability, and safety tracking—barriers to cheaper biologics and approvals.

The FDA has approved ranibizumab-hkdz (Ranluspec; Lupin Limited) as an interchangeable biosimilar for wet AMD, DME, DR, RVO, and mCNV.

FDA approval clears interchangeable golimumab biosimilars for rheumatoid arthritis and ulcerative colitis, promising lower-cost TNF therapy.

Global biosimilar market shifts: Celltrion leads biosimilars in Asia, biosimilars in Europe expand, while Sandoz restructures and FDA hurdles loom.

Biologics eat 51% of drug spending despite being 5% of prescriptions, but the FDA's new draft guidance hopes more competition can close that gap.

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.