Regulatory

In the Effort to Develop Global Comparator Products, Biosimilars Lead the Way

February 1st 2019

By Kelly Davio

Biosimilars are often described as lagging behind generic drugs because there are fewer in the market and they have lower acceptance and uptake. However, according to stakeholders who spoke during the second day of the Medicines for Europe 18th Regulatory and Scientific Affairs Conference, held January 31 to February 1 in London, United Kingdom, biosimilars are leading the way in the effort to create global comparator products for use in drug development.

The Top 5 Biosimilars Articles for the Week of January 28

February 1st 2019

The Center for Biosimilars® recaps the top news for the week of January 28, 2019.

Innovent Seeks Chinese Regulatory Approval for Proposed Biosimilar Bevacizumab

January 30th 2019

By Samantha DiGrande

Innovent Biologics, a China-based biopharmaceutical company, recently submitted a New Drug Application for its proposed bevacizumab biosimilar, IBI-305, referencing Avastin, to the Chinese regulatory agency, the National Medical Products Administration.

House Hears Testimony on Biosimilars' Role in Addressing High Drug Prices

January 30th 2019

By Kelly Davio

The House Committee on Oversight and Reform held its first hearing into drug prices this week and received testimony that pointed to increased biosimilar competition as a part of the solution to the problem.

European Report Says M&As Affecting Biosimilars Need Scrutiny

January 29th 2019

By Samantha DiGrande

A specific focus of the European Commission and European Parliament is to investigate the effect potential mergers and acquisitions (M&As) will have on the state of the market.

Is It Time for a Global Reference Product for Biosimilars?

January 26th 2019

By Allison Inserro

On the last day of the 14th Biosimilars Summit, held January 22-23, 2019, in Alexandria, Virginia, the head of the FDA practice at Avalere discussed her point of view that enabling a global reference product for biosimilars would provide global access for patients.

The Top 5 Biosimilars Articles for the Week of January 21

January 25th 2019

The Center for Biosimilars® recaps the top news for the week of January 21, 2019.

Eye on Pharma: Sandoz's Biosimilar Etanercept Gains New Canadian Indication

January 22nd 2019

By The Center for Biosimilars Staff

Sandoz’s biosimilar etanercept, Erelzi, referencing the brand-name Enbrel, has been granted an indication for the treatment of psoriatic arthritis by Health Canada.

EU Draws Closer to Adopting SPC Manufacturing Waivers for Biosimilars and Generics

January 20th 2019

By The Center for Biosimilars Staff

The European Union has announced that The Committee of the Permanent Representatives of the Governments of the Member States to the European Union (Coreper) agreed this week on the European Council’s draft regulation that grants an exception to Supplementary Protection Certificates (SPCs).

Stakeholders Thinking About US Patent System Reform in 2019

January 19th 2019

By Allison Inserro

Closed-door sessions began last month on possible patent law reform in 2019 in the United States.