Ophthalmology

Biosimilars Roundup: Policy and Business Developments Signify a Busy August

August 31st 2021

By Tony Hagen

Policy developments, business milestones, and physician-led efforts to shape biosimilar absorption made August 2021 an active time for these lower-cost biologics.

Ranibizumab Biosimilar (Byooviz) Gains EU Marketing Authorization

August 30th 2021

Byooviz, developed by Samsung Bioepis, will be distributed by Biogen in the European Union, where it becomes the first ranibizumab biosimilar. An application is under review with the FDA.

Opinion: How to Get FDA Clinical Efficacy Testing Waivers for Biosimilars

August 28th 2021

By Sarfaraz K. Niazi, PhD

Clinical efficacy studies are not always required for biosimilars, and it's possible to resist if the FDA does ask for them. Sarfaraz K. Niazi, PhD, suggests a game plan.

Opinion: A Modified 351(a) Licensing Pathway for Biosimilars

August 21st 2021

By Sarfaraz K. Niazi, PhD

Use of the 351(k) biosimilar approval pathway entails legal challenges, high costs, and potentially higher clinical evidence standards. Sarfaraz K. Niazi, PhD, suggests that using the 351(a) pathway for standalone drugs and copy products may be faster and better. This is part 3 of a series.

Rumors of HHS Biosimilars Coding Change Spark Concerns

August 20th 2021

By Tony Hagen

Worries about what HHS will propose in its anticipated biologics pricing reform policy have been exacerbated by a rumored coding change.

UHC Changes Its Bevacizumab Policy Following AAO Complaint

August 19th 2021

UnitedHealthcare (UHC) backs away from its biosimilar inclusion policy after the American Academy of Ophthalmology (AAO) raises concerns about safety and lack of clinical evidence.

Centus Bevacizumab Candidate Demonstrates Equivalence in Phase 3 Study

August 19th 2021

By Tony Hagen

Centus Biotherapeutics reports positive findings from AVANA for its bevacizumab biosimilar candidate.

Report: Specialty Drug Cost Increase Eased a Little in 2020

August 12th 2021

By Tony Hagen

A report from Artemetrx details 2020 changes in demand for biosimilars and other specialty drugs, according to health plan spending. Dynamics that could affect future spending are also explained.

Payers Respond to AAO's Bevacizumab Biosimilar Contentions

August 11th 2021

By Tony Hagen

Payers defend their policies on biosimilars in ophthalmic settings following allegations from the American Academy of Ophthalmology (AAO).

An Interview With the AAO About Its Bevacizumab Concerns

August 10th 2021

By Tony Hagen

"[Payers] are incorrectly assuming that biosimilars of bevacizumab are going to behave the same as Avastin in the eye, and they’re making that assumption with absolutely no data," contends George Williams, MD, clinical spokesperson and past president of the American Academy of Ophthalmology (AAO).