Rare Disease

Ten Reasons Why Biosimilar Candidates Should Not Be Tested for Clinical Efficacy

October 31, 2020

Sarfaraz K. Niazi, PhD


The FDA may require comparative clinical efficacy for biosimilar approval, but on top of all the other required and available evidence, these trials add little value, Sarfaraz K. Niazi, PhD, states.

Pfizer's Biosimilar Revenues Soar 80%

October 27, 2020

Tony Hagen


The strong growth of biosimilars Pfizer recently launched in the United States are part of the success story, although reference etanercept (Enbrel) sales have seen major erosion.

Europeans Devise Checklist for Promoting Biosimilar Use

October 24, 2020

Deana Ferreri, PhD


European investigators have derived a set of core principals for developing higher utilization of biosimilars.

Revance Reports Positive Findings for Potential Botox Competitor

October 15, 2020

Tony Hagen


DaxibotulinumtoxinA met all end points in a study demonstrating longer duration of action, safety, and tolerability.

Alexion Offloads Market Share From Soliris

August 4, 2020

Skylar Jeremias


Amid the confusion of the pandemic, fundamental business strategies are reshaping the biosimilar playing field, according to corporate earnings reports.

Alexion Settles With Amgen Over Eculizumab Patents

June 3, 2020

Tony Hagen


In a settlement announced via a Securities and Exchange Commission filing, Alexion said it had settled with Amgen over eculizumab patent disputes, allowing Amgen to bring a competing biosimilar to market in 2025.

FDA Releases Framework for Assessing Gene Therapies in Anticipation of Future Filings

January 29, 2020

The Center for Biosimilars Staff


The documents include specific ones for hemophilia, retinal disorders, and rare diseases, as well as manufacturing, testing, and patient follow-up.

China Clears Phase 3 Trial for SB12, Samsung Bioepis' Biosimilar Eculizumab

January 11, 2020

Allison Inserro


It is the only biosimilar candidate referencing Soliris to be granted investigational new drug approval in China.

Data on Complement Inhibitors and Proposed Biosimilars Feature at ASH

December 10, 2019

Kelly Davio


During this week’s 61st meeting of the American Society of Hematology (ASH), researchers reported on eculizumab, a prospective biosimilar, and the long-acting ravulizumab.

Trouble Ahead for Alexion's Biosimilar Defense Strategy?

November 23, 2019

Kelly Davio


Roche’s Japan-based subsidiary, Chugai Pharmaceutical, has filed a new patent infringement suit against Alexion in the District Court of Delaware.