Regulatory

Opinion: The “Forgotten Molecules” May Reward Biosimilar Developers

October 2nd 2021

By Sarfaraz K. Niazi, PhD

The Center for Biosimilars® Advisory Board member Sarfaraz K. Niazi, PhD, explains an “against the grain” approach to tapping unmet need and revenue potential in biosimilars.

Medicines for Europe Experts Discuss EU Market for Biosimilars, Part I

September 28th 2021

Adrian van den Hoven, director general for Medicines for Europe, and Diogo Piedade, market access manager for Medicines for Europe, discuss the group’s recent EU report: Market Review—Biosimilar Medicine Markets.

September Roundup: Biosimilar Policy Recommendations, Clinical Developments, and Interviews

September 27th 2021

The month of September 2021 was chock-full of biosimilar news. From regulatory actions to policy initiatives to clinical news, no dust was gathering on the road toward wider biosimilar adoption.

FDA Tweaks Biosimilar Application Review Program

September 25th 2021

By Tony Hagen

Biosimilar User Fee Act reviews have been slowed by the pandemic and the FDA has opened a public comment period as it plots the course through 2027.

Cardinal Health Biosimilars Expert Discusses Dynamics of Byooviz Launch

September 24th 2021

The first ranibizumab biosimilar (Byooviz) has potential to alleviate financial burden associated with retinal conditions, but may not be the only new approval for ophthalmology treatment in 2022, explains Sonia T. Oskouei, PharmD, BCMAS, DPLA, vice president of biosimilars for Cardinal Health.

AAO Reacts to Ranibizumab Biosimilar Approval

September 23rd 2021

The Center for Biosimilars® spoke with George Williams, MD, clinical spokesperson for the American Academy of Ophthalmology (AAO), about the FDA’s recent approval of Byooviz (ranibizumab), the first biosimilar specifically approved for treatment of eye diseases.

Amgen Estimates $9.8 Billion in Cumulative US Biosimilar Savings

September 22nd 2021

By Tony Hagen

In a biosimilar trend report, Amgen discusses marketing achievements, US biosimilar policy, payer and provider acceptance of these agents, and the outlook for further growth.

Axinn’s Landmon Provides an Expert Legal Opinion on HHS’ Drug Price Strategy

September 22nd 2021

The HHS plan ordered up by President Biden for combatting high drug prices is a hodgepodge of ideas that have long circulated in Washington, DC, but can any of them be made to stick? An intellectual property and FDA policy expert, Chad Landmon, JD, shares his perspective.

FDA Delays Review of Alvotech's AVT02 Adalimumab Biosimilar Candidate

September 21st 2021

By Tony Hagen

Reykjavik, Iceland company Alvotech said the FDA review of its adalimumab candidate is held up by pandemic-related curbs on overseas inspections.

FDA Approves First Ophthalmology Biosimilar: A Ranibizumab

September 20th 2021

By Tony Hagen

Byooviz (ranibizumab) was approved for multiple ophthalmologic conditions, although market launch is at least 9 months away, owing to patent protections on the originator product.