Rheumatology

FDA Approves High-Concentration Formulation of Samsung Bioepis’ Humira Biosimilar

August 17th 2022

By Skylar Jeremias

The FDA approval of Samsung Bioepis’ high-concentration, citrate-free formulation of Hadlima, a biosimilar referencing Humira (adalimumab), is the first high-concentration adalimumab biosimilar to be approved in the United States.

Eye on Pharma: Celltrion Aims for Adalimumab Interchangeability; Phase 3 Results for Ustekinumab Biosimilar

August 16th 2022

By Skylar Jeremias

Article

Celltrion Healthcare set its sights on obtaining an interchangeability designation for its adalimumab biosimilar, and Formycon released positive findings from a phase 3 trial involving its ustekinumab biosimilar.

Study: Biosimilar Uptake, Rather Than Competition, Will Influence Price Decreases

August 15th 2022

By Skylar Jeremias

Article

Researchers found that the percentage of biosimilar uptake is a better predictor of whether prices of biologics will significantly decrease, refuting the argument that more biosimilars for a single reference product will have the biggest impact.

Prospective Study Finds Adalimumab Biosimilars Effective in IBD, but Fall Short of Infliximab Product

August 10th 2022

By Mary Caffrey

Article

Study authors found the pair of biosimilars performed as well as others that have been evaluated in inflammatory bowel disease (IBD), but concluded that the adalimumab biosimilars were less effective in IBD than an infliximab biosimilar previously studied.

Q&A: How Will Biobetters Fit Into the Growing Biologics Market? Celltrion Executive Explains

August 6th 2022

By The Center for Biosimilars Staff

Article

In an interview with The Center for Biosimilars®, Hyoung Ki Kim, vice chairman and CEO of Celltrion Healthcare, breaks down the benefits of biobetters, how they differ from biosimilars, and how they could alter the future landscape of the biologics industry.

BLA Accepted for Fresenius Kabi Tocilizumab Biosimilar

August 4th 2022

By The Center for Biosimilars

Article

In a statement, Fresenius Kabi officials said the company is rapidly expanding its portfolio in autoimmune and oncology conditions.

Vizient Market Outlook Report Predicts Trends for Adalimumab Biosimilars in 2023

August 2nd 2022

By Skylar Jeremias

Article

Vizient’s Pharmacy Market Outlook report offers predictions on how the emergence of adalimumab biosimilars in 2023 will affect the biosimilar industry and what actions should be taken in advance to ensure biosimilar adoption.

Companies Clinch Deals for Global Biosimilar Commercialization

July 26th 2022

By Skylar Jeremias

Article

Prestige Biopharma and Intas Pharmaceuticals join forces to partner on a bevacizumab biosimilar for multiple countries, and Hikma Pharmaceuticals makes a deal with Celltrion Healthcare for the commercialization of an adalimumab biosimilar.

Applications for Sandoz’ Tysabri, Humira Biosimilars Accepted for Review

July 25th 2022

By Skylar Jeremias

Article

Sandoz’ applications for its Tysabri biosimilar (natalizumab) and its high-concentration version of its Humira biosimilar (adalimumab) were accepted for review by the FDA and the European Medicines Agency.

Not So Different: How Health Policies May Take Shape in a Post-Humira-Exclusive Adalimumab Market

July 24th 2022

By Skylar Jeremias

Podcast

On this podcast episode, The Center for Biosimilars spoke with Chronis Manolis from UPMC Health Plan to discuss how health care policies may shift as adalimumab biosimilars referencing Humira come to market in 2023, including how providers and payers can ensure equitable access.