Regulatory

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.

Opinion: Impact of Inflation Reduction Act 2022—Addressing Critics

August 11th 2022

By Sarfaraz K. Niazi, PhD

Article

Sarfaraz K. Niazi, PhD, a professor, entrepreneur, and biosimilar advocate, took aim at criticisms of the Inflation Reduction Act to 2022 that was passed in the Senate and critiques the argument that the bill should be considered a “price control” measure.

$35 Insulin Cap for Private Sector Blocked From Budget Reconciliation Bill

August 8th 2022

By Skylar Jeremias

Article

While efforts to cap monthly insulin costs for Medicare patients at $35 survived a budget reconciliation bill in the Senate, Republicans blocked the measure from extending to the private sector.

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.

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.

Biosimilars Check-In: Celltrion Pushes for Yuflyma in Europe; Xbrane Updates on Ranibizumab Filing

July 21st 2022

By Skylar Jeremias

Article

In recent weeks, Celltrion Healthcare furthered its adalimumab biosimilar (Yuflyma) by launching the drug in Spain and Portugal and starting a clinical trial in France while Xbrane Biopharma provided an update on the FDA filing of its ranibizumab biosimilar.

Journal Publishes Letter on Banning Animal Testing for Biosimilars

July 12th 2022

By Skylar Jeremias

Article

A letter penned by Sarfaraz K. Niazi, PhD, advocating for the banning of animal testing requirements for biosimilar development was published in Science, suggesting the journal has softened to the idea that animal testing may not be as useful as originally thought.

Contributor: Good Bait and Fair Switch—Biosimilar Interchangeability, Substitution, and Choice

July 11th 2022

By Ivo Abraham, PhD

Article

Ivo Abraham, PhD, chief scientist of Matrix45 and a member of The Center for Biosimilars® Advisory Board, explains the difference between biosimilar interchangeability and substitution and weighs in on whether switching studies are necessary.