Latest Conference Articles

Biosimilars CEOs: Opportunities Abound, but Regulatory, “Branding” Hurdles Remain

Mary Caffrey

February 24 2022

There remains risk in the US market due to regulatory and legal hurdles—not to mention a combative political environment, according to executives who gathered last week during the “CEOs Unplugged” session at Access! 2022, held by the Association for Accessible Medicines (AAM) in Orlando.

CMS Seeks Answers for Slower-Than-Expected Biosimilar Adoption, Rawal Says

Mary Caffrey

February 21 2022

Purva Rawal, PhD, senior advisor and chief strategy officer, Center for Medicare and Medicaid Innovation, spoke during the Association for Accessible Medicines' Access! annual meeting, which gathered in Orlando, Florida, February 15-16.

Experts Call for More Regulatory Action to Address Biosimilar Interchangeability Confusion

Skylar Jeremias

February 17 2022

A panel of experts details the current concerns regarding interchangeability designations for biosimilars in the United States and calls for regulators and policy makers to make changes to allow to easier access to biosimilars and greater adoption.

Panelists Discuss Regulatory Perspective on Biosimilars

Tony Hagen

December 20 2021

A trio of regulatory experts discuss the current standing of biosimilar policy in the United States and expectations going forward.

Molecular Selection Boosts pCR Rate in Early Breast Cancer Trial

Tony Hagen

December 20 2021

Investigators said pathologic complete response (pCR) improved in a trastuzumab biosimilar/pertuzumab trial when patients were preselected for a subtype of breast cancer.

SB12 Eculizumab Biosimilar Candidate Demonstrates PK, PD Equivalence in Phase 1 Trial

Tony Hagen

December 18 2021

In a pharmacokinetic (PK) and pharmacodynamic (PD) trial in healthy participants, Samsung Bioepis' SB12 eculizumab biosimilar candidate demonstrated equivalence to Soliris, the reference product.

Biosimilar-Gedatolisib Combo Elicits Response in Resistant mBC

Tony Hagen

December 14 2021

In metastatic breast cancer (mBC) resistant to multiple lines, Herzuma (a trastuzumab biosimilar) plus gedatolisib, an mTOR/PI3K signaling pathway inhibitor, demonstrated value.

Patient-Provider Surveys Elucidate Biosimilar Switching Process in Oncology

Tony Hagen

December 13 2021

After a switch to a biosimilar, patients and their oncologists may not always agree on how well the switch was described or whether the patient felt involved.

Ontruzant Biosimilar Demonstrates Equivalence to Herceptin in 5-Year Study

Tony Hagen

December 9 2021

The trial included "drifted" (nonstandard) reference product, forcing a stratified analysis to yield relevant data.

EirGenix Trastuzumab Biosimilar Candidate Demonstrates Equivalence in HER2-Positive Breast Cancer

Tony Hagen

December 8 2021

A trastuzumab biosimilar candidate demonstrated equivalence to Herceptin in patients with early-stage human epidermal growth factor receptor 2 (HER2)–breast cancer.