Regulatory

What Can US Learn About Biosimilars From Europe?

May 24th 2019

By Allison Inserro

Europe has several lessons for the US biosimilar market, according to a pharmaceutical executive who spoke during ISPOR 2019.

Health Canada Approves Its First Biosimilar Trastuzumab, Ogivri

May 22nd 2019

By The Center for Biosimilars Staff

Health Canada has approved Mylan and Biocon’s trastuzumab biosimilar, Ogivri, referencing Herceptin. The product, also approved in the United States, the European Union, and elsewhere, is the first biosimilar trastuzumab to be approved in Canada, and carries indications for HER2-positive breast cancer and HER2-positive metastatic stomach cancer.

FDA Releases Draft Guidance on Comparative Analytical Assessment for Biosimilars

May 21st 2019

By Kelly Davio

The FDA today released draft guidance on the design and evaluation of comparative analytical studies that are intended to support a demonstration of biosimilarity. A previous draft guidance document on statistical approaches to evaluate analytical similarity was withdrawn in June 2018.

A Critical Analysis of the Final Guidance on Demonstrating Interchangeability of a Biosimilar With Its Reference Product

May 21st 2019

By Sarfaraz K. Niazi, PhD

The final guidance on interchangeability resolves some issues, creates many new issues and inquiries, and offers a path—albeit not a clear one—that is filled with scientific and clinical challenges.

FDA Approves New Aflibercept Indication Ahead of Competition

May 17th 2019

By Kelly Davio

The FDA this week approved Regeneron’s aflibercept (Eylea) to treat all stages of diabetic retinopathy. The regulatory decision makes aflibercept the only anti–vascular endothelial growth factor therapy approved for 2 dosing regimens in this indication: every 8 weeks or every 4 weeks.

The Top 5 Biosimilars Articles for the Week of May 13

May 17th 2019

The Center for Biosimilars® recaps the top news for the week of May 13, 2019.

Sandoz's Francisco Ballester Discusses Biosimilars in Emerging Markets

May 14th 2019

By Kelly Davio

During the inaugural Biosimilars Commercialisation Summit, held May 14-15, 2019, in Amsterdam, the Netherlands, Francisco Ballester, MBA, head of the international region for Sandoz, discussed some of the key considerations that biosimilar developers face in emerging markets with The Center for Biosimilars®.

FDA Hears From Stakeholders About Insulin Transition to Biologic Pathway in 2020

May 14th 2019

By The Center for Biosimilars Staff

Set against a backdrop of rising concern about the cost of insulin, the FDA held a hearing about biosimilar insulins Monday, 10 months before the products transition in March 2020 from the Food Drug and Cosmetic Act to biologics under the Public Health Service Act.

FDA Guidance on Biosimilar Interchangeability Hits the Right Points, Stakeholders Say

May 13th 2019

By Allison Inserro

The guidance explains that the data and information needed to meet the legal standard for interchangeability, which shows that the proposed interchangeable product can be expected to produce the same clinical result as the reference product in any given patient, will vary by case.

FDA Finalizes Guidance on Interchangeable Biosimilars

May 10th 2019

By Kelly Davio

The FDA has released its long-awaited final guidance on demonstrating interchangeability of a biosimilar with its reference.