FDA Approves Kirsty as First Interchangeable Insulin Aspart Biosimilar

July 15, 2025

The FDA has approved Kirsty, the first interchangeable insulin aspart biosimilar, enhancing access to affordable diabetes care for millions.

White Paper Offers Tips for Sustaining Biosimilar Progress, Avoiding a Market Void

July 15, 2025

BioRationality: How the FDA Can Bypass Congress to Change Biosimilar Guidance

July 14, 2025

Balancing Cost Savings With Clinical Practice for Multiple Myeloma Biosimilars: Tyler Sandahl, PharmD

July 14, 2025

Inpatient Biosimilar Use Grows, Offering Cost-Saving Opportunities for Health Systems

July 11, 2025

Stability of Biosimilar Insulin Aspart Using an Insulin Pump Was Comparable With NovoLog, Study Finds

May 20th 2023

By Deana Ferreri, PhD

Article

Authors of a new in vitro study said Sanofi’s biosimilar SAR341402, approved in June 2020 by the European Medicines Agency for use in insulin pumps, had similar stability compared with the originator under stress conditions in their experiments.

The Top 5 Biosimilar Articles for the Week of May 15

May 19th 2023

By Justina Petrullo

Video

Here are the top 5 biosimilar articles for the week of May 15, 2023.

Biosimilars Business News Recap: A New Partnership; Celltrion Wins Tenders

May 17th 2023

By Skylar Jeremias

Article

As Sandoz and Just-Evotec Biologics announce a new partnership, Celltrion secures tender wins in Italy and Belgium, and Alvotech begins testing its golimumab biosimilar in patients with rheumatoid arthritis.

Fylnetra Launches in the United States

May 16th 2023

By Skylar Jeremias

Article

Amneal Pharmaceuticals has announced the launch of its pegfilgrastim biosimilar, Fylnetra (pegfilgrastim-pbbk), for the treatment and prevention of febrile neutropenia, making it the sixth biosimilar referencing Neulasta to enter the US market.

Biorationality: Advice for the FDA, Biosimilar Developers on Reducing the Cost of Clinical Testing

May 15th 2023

By Sarfaraz K. Niazi, PhD

Article

Although the FDA has consistently edited its testing guidelines for biosimilar developers over the years, clinical testing is still very expensive and time-consuming. Sarfaraz K. Niazi, PhD, offers the FDA and companies a plan of action for reducing clinical testing expenses for biosimilar products.

Dr Vibeke Strand: The Current State of Immunology Biosimilars and the Promise of Future Savings

May 14th 2023

By Skylar Jeremias

Article

In light of 2 blockbuster originators, namely Humira (adalimumab) and Stelara (ustekinumab), losing market exclusivity in 2023, 3 doctors penned supplement in The American Journal of Managed Care®. On this episode, Vibeke Strand, MD, one of the co-authors, explored how health systems can take charge and boost biosimilar adoption.

Tocilizumab Biosimilar LZM008 Demonstrates PK Equivalence in Healthy Participants

May 13th 2023

By Deana Ferreri, PhD

Article

A phase 1 clinical trial in China comparing the tocilizumab biosimilar candidate LZM008 to the reference product (Actemra) found pharmacokinetic (PK) parameters within the bioequivalence margins and similar immunogenicity and safety in healthy participants.

The Top 5 Biosimilar Articles for the Week of May 8

May 12th 2023

By Justina Petrullo

Video

Here are the top 5 biosimilar articles for the week of May 8, 2023.

Julie Reed: The Status Quo for Biosimilars Needs to Change to Maintain the Industry

May 11th 2023

By Skylar Jeremias

Article

The 2023 Asembia Specialty Pharmacy Summit featured Juliana (Julie) Reed, executive director of the Biosimilars Forum, who spoke on the challenges still facing the biosimilars industry and how they may impact the success of adalimumab biosimilars in the United States.

Samsung Bioepis Report Correlates Biosimilar Pricing Changes With Market Adoption

May 10th 2023

By Skylar Jeremias

Article

In the first edition of Samsung Bioepis’ Biosimilar Market Report, the company outlined the current state of the US biosimilars market and how increasing adoption has had an impact on pricing changes for biosimilars and their reference products.