Development

Positive Results for Aflibercept Biosimilars Seen at AAO 2022

October 5th 2022

By Skylar Jeremias

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.

Biosimilars Development Check-in: New Data for Celltrion, Samsung Bioepis Candidates

September 7th 2022

By Skylar Jeremias

Article

Celltrion Healthcare released positive data for an ustekinumab biosimilar, and Samsung Bioepis announced long-term safety and efficacy results for its adalimumab biosimilar.

Alvotech Brings in $40 Million in Revenue for First Half of 2022

September 5th 2022

By Skylar Jeremias

Article

Thanks to the success of its adalimumab biosimilar in Canadian and European markets, Alvotech’s revenues reached over $40 million during the first 6 months of 2022, nearly 20 times more than its revenue from the same period in 2021.

Upcoming WHO Guideline Changes May Reduce Data Requirements for Biosimilar Development

September 3rd 2022

By Deana Ferreri, PhD

Article

In advance of the World Health Organization (WHO) updating its guidelines for biosimilar development, a review article concluded that comparative clinical efficacy and safety studies may not be helpful for the evaluation of biosimilars.

Dr Ivo Abraham Column: It's What We Do With the Savings—Economics and Equity

August 30th 2022

By Ivo Abraham, PhD

Article

Ivo Abraham, PhD, chief scientist of Matrix45 and a professor at the University of Arizona, describes the pharmacoeconomics of biosimilars and the savings potential for practices and payers if they prioritize greater biosimilar adoption.