Neurology

FDA Approves First MS Biosimilar

August 25th 2023

By Skylar Jeremias

Article

The FDA approved its first biosimilar indicated for multiple sclerosis (MS), Sandoz’ Tyruko (natalizumab-sztn), a biosimilar referencing Tysabi (natalizumab).

Eye on Pharma: First PBM to Cover Yusimry; Celltrion to Test Ocrevus Biosimilar; Another Stelara Settlement

June 15th 2023

By Skylar Jeremias

Article

SmithRx becomes the first pharmacy benefit manager (PBM) to announce it will cover Yusimry, 1 of 9 FDA-approved adalimumab biosimilars; Celltrion Healthcare receives a thumbs-up from the FDA to test a biosimilar for Ocrevus; Alvotech and Teva Pharmaceuticals settle with Johnson & Johnson over their biosimilar referencing Stelara.

Celltrion Launches Biobetter in Brazil, Shares Phase 3 Plan for MS Biosimilar

May 22nd 2023

By Skylar Jeremias

Article

As Celltrion Healthcare announces the launch of the biobetter version of Remsima (Remsima SC) in Brazil, the company shared the phase 3 plan for its ocrelizumab biosimilar to treat multiple sclerosis (MS).

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.

IQVIA: Neurologists Are Excited for MS Biosimilars in Europe

April 5th 2023

By Skylar Jeremias

Article

In IQVIA’s latest report, neurologists in Europe reported feeling positive about the biosimilars for multiple sclerosis (MS) coming down the pipeline, showing that industry-wide education efforts and experience with biosimilars are working to instill greater confidence in these products.

Comparable Safety, Efficacy Between First Proposed Natalizumab Biosimilar, Reference for MS

March 3rd 2023

By Justina Petrullo

Article

Phase 3 study findings support a proposed natalizumab biosimilar (PB006) as the first biosimilar alternative to reference natalizumab (Tysabri) for treatment of relapsing-remitting multiple sclerosis (MS).

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.

What Should Educational Materials Include to Instill Confidence in Biosimilars?

March 25th 2021

By Skylar Jeremias

Article

A panel of physicians gave advice on how biosimilar educational materials should instill confidence in these medications and which policies may be more harmful than beneficial.

Providers Exploit Minor Differences Between Innovator Drugs and Biosimilars

November 24th 2020

By Skylar Jeremias

Article

Minute differences between biosimilars and reference products are not considered “clinically meaningful,” but these differences are exploitable when it comes to addressing allergies related to originator products.

IGBA Launches Global Biosimilars Week

November 16th 2020

By Tony Hagen

Article

The International Generic and Biosimilar Medicines Association (IGBA) hopes to build momentum for the use of biosimilars.