Development

Eye on Pharma: Celltrion, Costco Partnership; Amgen Sues Samsung Bioepis; Denosumab Results

August 21st 2024

By Skylar Jeremias

Celltrion's adalimumab-aaty biosimilar is now accessible for all Costco members, while Amgen sues Samsung Bioepis over the latter’s denosumab biosimilar candidate, and GlycoNex progresses its denosumab biosimilar SPD8 to phase 3 trials.

BioRationality: FDA Simplifies Glycan Profiling of mAbs, a Significant Step in Reducing the Cost of Biosimilars

July 29th 2024

By Sarfaraz K. Niazi, PhD

Article

The FDA's new policy on glycan profiling of monoclonal antibodies (Mabs) receives praise and recommendations from Sarfaraz K. Niazi, PhD.

Phase 1 Study Shows Promise for Dulaglutide Biosimilar

July 25th 2024

By Skylar Jeremias

Article

A biosimilar dulaglutide showed similar pharmacokinetic and safety profiles compared with the reference product Trulicity in healthy Chinese participants, according to a phase 1 analysis.

Eye on Pharma: New Data, Clinical Developments, and Biosimilar Partnerships

July 4th 2024

By Skylar Jeremias

Article

As Celltrion publishes phase 3 data on its tocilizumab biosimilar, other companies finalize partnerships, and Formycon begins development for a pembrolizumab biosimilar.

BioRationality: FDA Removes Additional Testing for Interchangeable Status of Biosimilars

July 1st 2024

By Sarfaraz K. Niazi, PhD

Article

Sarfaraz K. Niazi, PhD, champions the FDA's updated guidance to remove switching study data for companies seeking to obtain an interchangeability designation for their biosimilars.

BioRationality—How to Promote Science to Secure Waiver of Comparative Efficacy Testing for Biosimilars

June 17th 2024

By Sarfaraz K. Niazi, PhD

Article

Sarfaraz K. Niazi, PhD, makes suggestions for what arguments will help convince the FDA to waive clinical efficacy testing requirements for biosimilar approvals.

EHA Poster Shows Transfusion Avoidance Rates Were Comparable Between Eculizumab Biosimilar, Soliris

June 15th 2024

By Skylar Jeremias

Article

A poster from the European Hematology Association’s (EHA) 2024 annual meeting in Madrid, Spain, showed similar rates of transfusion avoidance between patients with paroxysmal nocturnal hemoglobinuria who were administered reference eculizumab (Soliris) and those administered an eculizumab biosimilar (SB12).

New Data Show Safety of Ado-Trastuzumab, Trastuzumab Biosimilars in HER2+ Cancers

June 11th 2024

By Skylar Jeremias

Article

Posters from the American Society of Clinical Oncology annual meeting showcased safety and efficacy data for a trastuzumab biosimilar and an ado-trastuzumab biosimilar in HER2-positive (HER2+) cancers.

Biosimilars Check-In: Application Acceptances, European Approvals, New Partnerships

June 6th 2024

By Skylar Jeremias

Article

American and European regulatory agencies have provided companies with good news, with several biosimilar candidates seeing application acceptances or approvals in Europe.

DDW 2024 Posters Evaluate Safety, Efficacy, Impact of BMI on Zymfentra Use

May 21st 2024

By Skylar Jeremias

Article

Posters from Digestive Disease Week (DDW) on the ongoing LIBERTY-CD trial assessing Zymfentra, a subcutaneous infliximab product, compared with intravenous infliximab treatment in Crohn disease show the safety and efficacy of the product, as well as the impact of body mass index (BMI) on clinical outcomes.