FDA Issues Draft Guidance Aimed at Cutting Expenses for Biosimilar PK Studies

Postmenopausal Osteoporosis: Clinical Burden, Treatment Barriers, and the Evolving Role of Denosumab Biosimilars

February 25th 2026

Cardinal Health Biosimilar Report: $56 Billion in Savings and the Road to Market Sustainability

February 24th 2026

By Skylar Jeremias

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

February 20th 2026

By Skylar Jeremias

Real-world India data show trastuzumab emtansine biosimilars deliver meaningful PFS and manageable safety in heavily pretreated HER2+ metastatic breast cancer.

FDA Approves Filkri, Accord BioPharma’s Short-Acting Filgrastim Biosimilar for Neutropenia

February 18th 2026

By Sabrina McCrear

FDA approval of Filkri expands Accord’s G-CSF biosimilar portfolio, offering a short-acting option for neutropenia in cancer care.

Danish Registry Analysis Finds Consistent Safety After Switching to Infliximab Biosimilar GP1111

February 3rd 2026

By Skylar Jeremias

New Danish registry data confirm the safety of switching to infliximab biosimilars, showing low rates of serious adverse events in patients with inflammatory arthritis.

Q&A With Chelsee Jensen, PharmD: FDA Policy Shifts, Biosimilar Development Hurdles, and Market Access in 2026

February 2nd 2026

By Sabrina McCrear

Mayo Clinic’s Chelsee Jensen, PharmD, discusses FDA policy changes, biosimilar development hurdles, denosumab lessons, and payer access strategies.

Early Evidence Supports KM118 as a Biosimilar to Reference Pertuzumab

January 28th 2026

By Skylar Jeremias

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

January 27th 2026

By Skylar Jeremias

The US biosimilar market evolves with 90 approvals, significant price drops, and new PBM models enhancing access to cost-effective therapies.

FDA Draft Guidance on Biosimilars Is a Win for Patients; Now Congress Must Finish the Job

January 26th 2026

By Alex Keeton

Biosimilar Competition Linked to Lower Out-of-Pocket Costs for Medicare Patients

January 21st 2026

By Skylar Jeremias

Biosimilar competition significantly reduces out-of-pocket costs for Medicare patients, enhancing affordability for biologic therapies and improving access.