Regulatory

Dan Leonard Takes Helm of Association for Accessible Medicines

August 27th 2020

By Tony Hagen

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

Expert Opinion Roundup: New Insulin and Biosimilar Regulation

August 26th 2020

By Skylar Jeremias

Article

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

Biogen: Anti-TNF Biosimilars Are Underutilized

August 25th 2020

By Tony Hagen

Article

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

BeiGene, Bio-Thera Carve Out Bevacizumab Market

August 24th 2020

By Tony Hagen

Article

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

Formycon, Bioeq Enroll First Patient in Phase 3 Aflibercept Study

August 24th 2020

By Tony Hagen

Article

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

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

August 20th 2020

By Tony Hagen

Article

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.

Samsung Bioepis' Bevacizumab Is Cleared for Launch in Europe

August 20th 2020

By Tony Hagen

Article

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

Sandoz Canada Launches Ziextenzo, Riximyo

August 19th 2020

By Skylar Jeremias

Article

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

Fauci Discusses Experimental COVID-19 Drugs and School Openings

August 19th 2020

By Tony Hagen

Article

Monoclonal antibodies may play a frontline role in dealing with COVID-19 infections, according to Anthony S. Fauci, MD.

US May Need to Look to Germany to Reform Drug Pricing

August 19th 2020

By Skylar Jeremias

Article

US administrative and legislative efforts are moving the United States and Germany more into alignment on drug cost management philosophy, according to a review.