Skylar Jeremias is the Managing Editor for The Center for Biosimilars and The American Journal of Managed Care (AJMC).
FDA Accepts Sandoz Generic Tirzepatide Applications Amid Biosimilar Development Gap
Sandoz moves toward US generic tirzepatide autoinjectors as FDA reviews ANDAs, signaling future GLP‑1 access amid patent and biosimilar gaps.
Anti-VEGF Biosimilars Match Reference Drug in Indian Retinal Disease Care
Biosimilar anti-VEGF agents matched the reference ranibizumab in vision outcomes and safety across retinal diseases in India, at a lower cost.
Rituximab Biosimilar Reached 75% Remission, Matched Innovator in Membranous Nephropathy
Real-world data shows rituximab biosimilars for membranous nephropathy match remission rates, cut costs, and expand treatment options.
Biosimilar ABP 654 Maintains Efficacy, Safety After Repeated Switching From Ustekinumab
Trial data show switching between ABP 654 and reference ustekinumab maintains similar psoriasis control, safety, and immunogenicity, supporting FDA interchangeability confidence.
Biosimilar Denosumab Matches Reference Drug for Bone Density in Chinese Women
Phase 3 data show denosumab biosimilar KN012 matches Prolia for BMD gains and safety, potentially expanding affordable osteoporosis care.
Biosimilar Makers Push Forward on Regulatory and Commercial Fronts
FDA expands Tofidence uses, Teva launches Eylea biosimilar in Europe, and Alvotech’s Entyvio rival enters FDA review—boosting access.
Positioning Biosimilar Ustekinumab Early Reduces Burden on Spain's National Health System
Early use of ustekinumab biosimilars in Spain shows cost-effective Crohn disease care, boosting QALYs and cutting NHS spend—insights for Europe.
Global Biosimilar Rules Diverge Across WHO Regions, Limiting Patient Access
Global review reveals uneven biosimilar rules on waivers, interchangeability, and safety tracking—barriers to cheaper biologics and approvals.
Low Biosimilar Awareness in MS Patients Points to Critical Gap in Nurse-Led Education
Italian study finds most MS patients start biosimilars unaware, exposing education gaps and highlighting MS nurses as key to boosting trust and uptake.
Biosimilar Expansion, Lower Costs Drive Shift in RA Treatment Guidelines
New EULAR guidelines speed RA treatment switches as rheumatoid arthritis biosimilars and cost savings push earlier biologics use.
Biosimilar Switching Maintained Disease Control in People With Ankylosing Spondylitis
Evidence shows biosimilars switching in ankylosing spondylitis maintains disease control with biologics, cuts costs, and highlights nocebo risks.
Golimumab Biosimilar Matches Reference Drug in Year-Long RA Trial
One-year trial shows AVT05 golimumab biosimilar matches Simponi in rheumatoid arthritis, including switching, with comparable safety and immunogenicity outcomes.
Switching to Biosimilar Etanercept Shows No Impact on Efficacy, Safety Across 18 Trials
Real-world evidence shows switching between etanercept products and etanercept biosimilars preserves efficacy and safety, easing concerns and highlighting nocebo challenges.
Gaps in Knowledge Persist Around Biosimilar Insulin Switching, Review Finds
Scoping review shows clinicians and patients still worry about biosimilar insulin switching, devices and safety—evidence gaps shape insulin product swaps.
Global Biosimilar Market Sees Structural Shifts, Regulatory Hurdles, and Pipeline Gains
Global biosimilar market shifts: Celltrion leads biosimilars in Asia, biosimilars in Europe expand, while Sandoz restructures and FDA hurdles loom.
FDA Issues Draft Guidance Aimed at Cutting Expenses for Biosimilar PK Studies
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.
Clinician Confidence in Ophthalmology Biosimilars Remains Low Across Europe
A new analysis dives into why Europe’s eye clinics lag on biosimilars and how education, guidance, and smarter tenders could unlock €747 million in savings.
Biosimilars Development Roundup: Expanding Global Options Amidst Rising US Legal Hurdles
CHMP backs a fifth teriparatide biosimilar as biosimilars in Europe grow, while US patent fights threaten new biologic competition.
Biosimilar-Backed Triplet Regimen Shows Feasibility in Heavily Pretreated Liver Cancer
A phase 2 trial showed that combining targeted radiotherapy with PD-1 blockade and a bevacizumab biosimilar can elicit responses in advanced liver cancer.
Omalizumab Biosimilar Entry Linked to Expanded Patient Access, Reduced Spending
Budget impact analysis finds omalizumab biosimilars in Europe could cut payer costs by €641M in 5 years, expanding access and driving major omalizumab savings.
Cardinal Health Biosimilar Report: $56 Billion in Savings and the Road to Market Sustainability
Biosimilars save billions, but FDA’s new guidance, physician concerns, and Humira switchbacks reveal hurdles to a sustainable US market.
Biosimilar Trastuzumab Emtansine Shows Consistent PFS in HER2-Positive Breast Cancer
Real-world India data show trastuzumab emtansine biosimilars deliver meaningful PFS and manageable safety in heavily pretreated HER2+ metastatic breast cancer.
Danish Registry Analysis Finds Consistent Safety After Switching to Infliximab Biosimilar GP1111
New Danish registry data confirm the safety of switching to infliximab biosimilars, showing low rates of serious adverse events in patients with inflammatory arthritis.
Early Evidence Supports KM118 as a Biosimilar to Reference Pertuzumab
A new study confirms KM118, a proposed biosimilar to pertuzumab, shows pharmacokinetic similarity and safety, paving the way for affordable HER2-positive breast cancer treatments.
Milestone Approvals, Evolving PBM Models May Redefine the 2026 Biosimilar Landscape
The US biosimilar market evolves with 90 approvals, significant price drops, and new PBM models enhancing access to cost-effective therapies.
Biosimilar Competition Linked to Lower Out-of-Pocket Costs for Medicare Patients
Biosimilar competition significantly reduces out-of-pocket costs for Medicare patients, enhancing affordability for biologic therapies and improving access.
Perceptions Still Play a Central Role in Biosimilar Insulin Switching
Explore the complexities of insulin biosimilars, their safety, and the impact on diabetes management in global health systems.
Trial Data Support Equivalence of Denosumab Biosimilar in Postmenopausal Osteoporosis
Denosumab biosimilars enhance treatment access for postmenopausal osteoporosis, demonstrating equivalent efficacy and safety to reference products in recent trials.
What Australia’s Experience Reveals About Biosimilar Adoption and Pricing
Australia's biosimilar adoption significantly reduces biologic medicine costs, enhancing access while maintaining utilization amid tighter health care budgets.
Eye on Pharma: Global Approvals, Launches, and Strategic Partnerships