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FDA Draft Guidance on Biosimilars Is a Win for Patients; Now Congress Must Finish the Job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

The Top 5 Biosimilar Articles for the Week of September 25

September 29th 2023

By Justina Petrullo

Video

Here are the top 5 biosimilar articles for the week of September 25, 2023.

Secukinumab Found Cost-Effective for Patients With Moderate to Severe Psoriasis

September 28th 2023

By Justina Petrullo

Article

Compared with other biologics frequently used in China for moderate-to-severe psoriasis, secukinumab is the most cost-effective treatment option.

EC Approves First MS Biosimilar; Coherus Receives CRL for Neulasta Onpro Competitor

September 27th 2023

By Skylar Jeremias

Article

With the European Commission's (EC) approval of Tyruko, Europe receives its first natalizumab biosimilar and first biosimilar to treat multiple sclerosis (MS), while Coherus Biosciences received a complete response letter (CRL) for its biosimilar for Neulasta Onpro.

Study: Multiple Switches Between Infliximab Products May Lead to Higher Rates of Treatment Discontinuation

September 26th 2023

By Skylar Jeremias

Article

Patients with inflammatory bowel disease who underwent a switch from reference infliximab to a biosimilar and then back to the originator were more likely to discontinue their treatment than patients who underwent a single switch from the originator to a biosimilar.

Alvotech’s Stelara Biosimilar Approved in Japan

September 25th 2023

By Skylar Jeremias

Article

Iceland-based Alvotech announced the approval of its ustekinumab biosimilar referencing Stelara in Japan for autoimmune conditions. The company also released an update on the US filing for its adalimumab biosimilar.

Higher-Cost Therapies for ARMD Could Contribute to Heightened Medicare Costs; Biosimilars Could Help

September 24th 2023

By Justina Petrullo

Article

Drug maker payments to ophthalmologists were associated with the choice of higher-cost therapies for age-related macular degeneration (ARMD) that could increase Medicare costs, but biosimilars could help.

House Committee Hearing Addresses PBMs, Anticompetitive Drug Pricing Tactics

September 23rd 2023

By Gillian McGovern

Article

The House Committee members examined pricing tactics by PBMs and how they are harming patients across the country.

The Top 5 Biosimilar Articles for the Week of September 18

September 22nd 2023

By Justina Petrullo

Video

Here are the top 5 biosimilar articles for the week of September 18, 2023.

European Commission Approves First Aflibercept Biosimilar

September 21st 2023

By Skylar Jeremias

Article

The European Commission approved the first aflibercept biosimilar, which will be used to treat patients with age-related macular degeneration and diabetic macular edema.

Part 3: BioRationality—FDA Webinar on Biosimilars Efficacy Testing Marks Major Step Forward

September 20th 2023

By Sarfaraz K. Niazi, PhD

Article

In the final part of a 3-part series, Sarfaraz K. Niazi, PhD, gives his take on the FDA's recent workshop dedicated to streamlining biosimilar development and his opinion on what the industry can learn from the webinar presenters.