Development

BioRationality: Withdrawal of Proposed Terminal Disclaimer Rule Spells Major Setback for Biosimilars

December 10th 2024

By Sarfaraz K. Niazi, PhD

The United States Patent and Trademark Office (USPTO)’s withdrawal of its proposed terminal disclaimer rule is seen as a setback for biosimilar developers, as it preserves patent prosecution practices that favor originator companies and increases costs for biosimilar competition, according to Sarfaraz K. Niazi, PhD.

Eye on Pharma: Golimumab Biosimilar Update; Korea Approves Denosumab; Xbrane, Intas Collaboration

December 10th 2024

By Skylar Jeremias

Alvotech and Advanz Pharma have submitted a European marketing application for their golimumab biosimilar to treat inflammatory diseases, while Celltrion secured Korean approval for denosumab biosimilars, and Intas Pharmaceuticals partnered with Xbrane Biopharma on a nivolumab biosimilar.

Pertuzumab Biosimilar Shows Promise in HER2-Positive Breast Cancer Treatment

December 9th 2024

By Skylar Jeremias

The proposed pertuzumab biosimilar QL1209 demonstrated equivalent efficacy and safety to reference pertuzumab (Perjeta) in neoadjuvant treatment of HER2-positive, ER/PR-negative early or locally advanced breast cancer, offering a cost-effective alternative with comparable clinical outcomes.

Aflibercept Biosimilar MYL-1701P Provides Equivalence in DME Therapy

November 27th 2024

By Skylar Jeremias

The study findings demonstrate that the aflibercept biosimilar MYL-1701P is as effective and safe as the reference aflibercept in treating diabetic macular edema (DME), offering a promising option for reducing treatment costs and improving global access to care for patients with DME.

Ocrelizumab Biosimilar Shows Equivalent Efficacy as Multiple Sclerosis Treatment

November 26th 2024

By Skylar Jeremias

The phase 3 trial (NCT04966338) found that a biosimilar ocrelizumab candidate (Xacrel) was equivalent to Ocrevus in reducing the annualized relapse rate and showed comparable safety and efficacy in treating relapsing multiple sclerosis over 96 weeks.

Boosting Health Care Sustainability: The Role of Biosimilars in Latin America

November 21st 2024

By Skylar Jeremias

Biosimilars could improve access to biologic treatments and health care sustainability in Latin America, but their adoption is hindered by misconceptions, regulatory gaps, and weak pharmacovigilance, requiring targeted education and stronger regulations.

BioRationality: A Proposal to Create a New Association With Rational Scientific Agenda

November 18th 2024

By Sarfaraz K. Niazi, PhD

Breaking Down Biosimilar Barriers: Interchangeability

November 14th 2024

By Dracey Poore

Part 3 of this series for Global Biosimilars Week, penned by Dracey Poore, director of biosimilars at Cardinal Health, explores the critical topic of interchangeability, examining its role in shaping biosimilar adoption and the broader implications for accessibility.

Eye on Pharma: Henlius, Organon Updates; Meitheal Portfolio Expansion; Celltrion Zymfentra Data

November 5th 2024

By Skylar Jeremias

Henlius and Organon’s pertuzumab biosimilar met phase 3 goals; Meitheal expanded its US biosimilars; Celltrion’s subcutaneous infliximab (Zymfentra) showed monotherapy could be as effective as combination therapy for inflammatory bowel disease.

BioRationality: Should mRNA Copies Be Filed as NDAs or Biosimilars?

November 4th 2024

By Sarfaraz K. Niazi, PhD

The article by Sarfaraz K. Niazi, PhD, argues that the FDA’s classification of future copies of messenger RNA (mRNA) products could be reconsidered, suggesting they might be eligible for new drug applications (NDAs) or a hybrid biosimilar category due to their unique characteristics and increasing prevalence.