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

February 03, 2026

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 02, 2026

Early Evidence Supports KM118 as a Biosimilar to Reference Pertuzumab

January 28, 2026

Milestone Approvals, Evolving PBM Models May Redefine the 2026 Biosimilar Landscape

January 27, 2026

FDA Draft Guidance on Biosimilars Is a Win for Patients; Now Congress Must Finish the Job

January 26, 2026

Ahzantive Receives FDA Approval as New Eylea Biosimilar

July 1st 2024

By Skylar Jeremias

Article

The FDA has approved Ahzantive (aflibercept-mrbb) as the third biosimilar referencing Eylea (aflibercept) for the treatment of eye conditions, including age-related macular degeneration.

FDA Approves Samsung Bioepis’ Pyzchiva, a Biosimilar to Stelara

July 1st 2024

By Skylar Jeremias

Article

Pyzchiva (ustekinumab-ttwe) is the third ustekinumab biosimilar to receive approval for the American market. It was also approved with interchangeability.

BioRationality: FDA Removes Additional Testing for Interchangeable Status of Biosimilars

July 1st 2024

By Sarfaraz K. Niazi, PhD

Article

Sarfaraz K. Niazi, PhD, champions the FDA's updated guidance to remove switching study data for companies seeking to obtain an interchangeability designation for their biosimilars.

Jeffrey Casberg of IPD Analytics Gives Insight on Specialty Drugs in the Pipeline

June 30th 2024

By Cameron Santoro

Video

In an interview with Jeffrey Casberg, MS, RPh, he discusses 3 promising specialty drugs coming through the pipeline. Casberg explains these drugs offer new treatment options for major diseases and stakeholders should watch for their potential impact on the market.

Phase 3 Trials Find Subcutaneous Infliximab CT-P13 Superior to Placebo in IBD

June 29th 2024

By Deana Ferreri, PhD

Article

Two phase 3 trials in patients with inflammatory bowel disease (IBD) found higher clinical remission rates in those treated with the subcutaneous formulation of infliximab biosimilar CT-P13 compared with placebo as maintenance therapy following an induction phase of intravenous CT-P13.

The Top 5 Biosimilar Articles for the Week of June 24

June 28th 2024

By Cameron Santoro

Video

Here are the top 5 biosimilar articles for the week of June 24, 2024.

EHA 2024: Rituximab Biosimilars Improve Quality of Life, Infusion-Related Reactions

June 27th 2024

By Skylar Jeremias

Article

Two posters presented at the European Hematology Association’s annual meeting (EHA 2024) evaluated how rituximab biosimilars impact quality of life and infusion-related reactions in patients with lymphatic cancers.

Biosimilar Adoption in the UK: Patient and Consultant Views on Safety and Switching

June 26th 2024

By Skylar Jeremias

Article

Lack of knowledge and confidence in biosimilars continues despite growing education efforts, impacting provider willingness to prescribe biosimilar medicines and patient perceptions about their treatment and switching to a biosimilar.

Authors Spotlight Long-Term Solutions to Ensure Biosimilar Market Sustainability

June 25th 2024

By Skylar Jeremias

Article

Authors of a commentary piece propose solutions to sustainability issues for biosimilar markets and shed light on common sustainability challenges global markets face.

ASCO Posters Reflect on Reimbursement Trends, Combination Therapies Involving Biosimilars

June 24th 2024

By Skylar Jeremias

Article

Two posters from the American Society of Clinical Oncology (ASCO) annual meeting look at Medicare reimbursement trends for originator and biosimilar biologics, as well as a combination therapy utilizing a pegfilgrastim biosimilar in patients with advanced hepatocellular carcinoma.