Development

Biosimilar Business News Recap: Mepolizumab Study; New Licensing Deal; Hukyndra Launches in Switzerland

October 18th 2022

By Skylar Jeremias

Article

Bio-Thera Solutions began a phase 1 trial for its mepolizumab biosimilar candidate; Biocon Biologics licenses out 2 biosimilars to Yoshindo; and Alvotech and STADA Arzneimittel launch Hukyndra, an adalimumab biosimilar, in Switzerland.

Contributor: The Biosimilars Wave Is Crashing on the Shores of Biopharma Development

October 17th 2022

By St John Skilton, PhD

Article

St John Skilton, PhD, vice president of product strategy and marketing at Protein Metrics, takes a deep dive into how the development of biosimilars is evolving and how tools, such as mass spectrometry, can help companies keep up with advancing technology.

Trastuzumab Biosimilar Found Safe, Effective in Pretreated HER2-Positive Breast Cancer

October 15th 2022

By Deana Ferreri, PhD

Article

A study from the Republic of Korea confirmed the safety and efficacy of Herzuma (CT-P16) in patients with heavily pretreated human epidermal growth factor receptor 2 (HER2)-positive metastatic breast cancer.

Dr Nabil Saba Shares His Hope for Future Opdivo, Keytruda Biosimilars

October 12th 2022

By Skylar Jeremias

Video

Nabil Saba, MD, a medical oncologist and immunotherapy specialist in the treatment of head and neck cancer at Emory Healthcare and the Winship Cancer Institute, explained how the eventual introduction of biosimilars for Opdivo (nivolumab) and Keytruda (pembrolizuamb) will help patients with head and neck cancer.

Positive Results for Aflibercept Biosimilars Seen at AAO 2022

October 5th 2022

By Skylar Jeremias

Article

Two posters presented at the annual conference of the American Academy of Ophthalmology (AAO) demonstrated positive phase 3 results for proposed biosimilars that reference blockbuster drug, Eylea (aflibercept).

A Guide to Biosimilars for Retinal Diseases

September 24th 2022

By Deana Ferreri, PhD

Article

In a review article discussing the role of biosimilars in neovascular retinal diseases, the authors concluded that biologics have significantly improved patient outcomes, noting that vascular endothelial growth factor inhibitors are now considered first-line treatments.

Biosimilar Insulin Lispro Shows Similar PK and PD Parameters to Humalog

September 17th 2022

By Skylar Jeremias

Article

A phase 1 study in Japan found similar pharmacokinetic (PK) and glucose pharmacodynamic (PD) parameters between the biosimilar SAR342434 (SAR-Lis, Sanofi) and the Japan-reference insulin lispro (Humalog) in healthy male participants.

Eye on Pharma: Good News, Bad News for Alvotech; EpiVax Secures FDA Grant for Biosimilar Testing

September 12th 2022

By Skylar Jeremias

Article

As Alvotech’s biosimilars are included in a commercialization deal in the Philippines, the company hits a setback in its quest for FDA approval of its adalimumab biosimilar; the FDA gives EpiVax a $2 million grant to run immunogenicity testing for biosimilars.

Phase 1 Study Demonstrates Bioequivalence Between Enoxaparin Biosimilar vs Reference Product

September 10th 2022

By Skylar Jeremias

Article

A phase 1 study of an enoxaparin sodium biosimilar Cloti-Xa established similar pharmacodynamics and pharmacokinetic profiles with the reference product (Clexane, Lovenox) in healthy participants.

Getting Rid of Clinical Efficacy Testing for Biosimilars Is Needed, Ethical

September 8th 2022

By Skylar Jeremias

Article

In a recent paper, Sarfaraz K. Niazi, PhD, argues that getting rid of clinical efficacy testing for biosimilars could realign testing ethics with current guidelines, save companies money on development, and improve data sensitivity.