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Tony Hagen is senior managing editor for The Center for Biosimilars

For all intents and purposes, Semglee is a biosimilar insulin, but official biosimilar status is needed to clinch the marketing aspect.

Biocon, Mylan Launch Semglee and Seek Biosimilar, Interchangeable Status 

Amanda DeMarzo, PharmD, MBA, PACS, is the associate director of Patient Access with the National Board of Prior Authorization Specialists, an affiliate of the Accreditation Council for Medical Affairs, based in Oradell, New Jersey. She focuses on how to improve the current health care system as a whole through improved training, widespread certification, and advanced technology for better patient outcomes. She developed a passion for patient-centered care and shared decision making during patient-facing roles over the last 8 years.

Coronavirus disease 2019 altered the workflow in all areas of the health care and life sciences industries, and the FDA was not exempt from pandemic-induced upheaval.

The Pandemic's Multilevel Effect on Patient Access

The Association for Accessible Medicines, which represents generic and biosimilar manufacturers, chose a leader with a research, public relations, and strategic planning background.

Dan Leonard Takes Helm of Association for Accessible Medicines

Opinion leaders discuss the significance of regulatory changes affecting biosimilar and insulin products.
 

Expert Opinion Roundup: New Insulin and Biosimilar Regulation

Two Biogen officials make the case for getting anti–tumor necrosis factor (TNF) biosimilars into wider play.

Biogen: Anti-TNF Biosimilars Are Underutilized

From China to Taiwan, BeiGene and Bio-Thera Solutions hope to capture a large share of the bevacizumab biosimilar market.

BeiGene, Bio-Thera Carve Out Bevacizumab Market

Multiple contenders are lining up for the pending expiration of patents on the blockbuster Regeneron reference product for wet age-related macular degeneration.

Formycon, Bioeq Enroll First Patient in Phase 3 Aflibercept Study

The buck stops with the FDA when it comes to approving coronavirus disease 2019 therapeutics applications, said Anand Shah, MD, deputy commissioner for Medical and Scientific Affairs at the FDA.

FDA Reassures on Biosimilar Progress as COVID-19 Applications Pile Up

Samsung Bioepis' latest approval gives it 5 biosimilar approvals in the European marketplace.

Samsung Bioepis' Bevacizumab Is Cleared for Launch in Europe

After receiving regulatory approval in June, Sandoz launched 2 of its biosimilars on the Canadian market.

Regulatory