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© 2026 MJH Life Sciences™ and The Center for Biosimilars - Biosimilars, Health Economics & Insights. All rights reserved.

Switching to Biosimilar Etanercept Shows No Impact on Efficacy, Safety Across 18 Trials

March 16, 2026

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

March 12, 2026

Global Biosimilar Market Sees Structural Shifts, Regulatory Hurdles, and Pipeline Gains

March 10, 2026

FDA Issues Draft Guidance Aimed at Cutting Expenses for Biosimilar PK Studies

March 09, 2026

Clinician Confidence in Ophthalmology Biosimilars Remains Low Across Europe

March 06, 2026

Featured Content

Biosimilars Development Roundup: Expanding Global Options Amidst Rising US Legal Hurdles

March 5th 2026

By Skylar Jeremias

Article

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

February 27th 2026

By Skylar Jeremias

Article

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

February 26th 2026

By Skylar Jeremias

Article

Budget impact analysis finds omalizumab biosimilars in Europe could cut payer costs by €641M in 5 years, expanding access and driving major omalizumab savings.

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

February 25th 2026

Article

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

February 24th 2026

By Skylar Jeremias

Article

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

Article

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

Article

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

Article

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

Article

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

Article

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.