Development

Formycon Starts Phase 1 Trial for Proposed Ustekinumab Biosimilar

October 28th 2019

By The Center for Biosimilars Staff

Drug maker Formycon announced today that it has begun a phase 1 clinical trial of its proposed ustekinumab biosimilar, FYB202, referencing Stelara. Ustekinumab is the first available therapy to target the interleukin-12 and -23 pathway.

Ahead of FDA Decision on ABP 710, Study Shows Biosimilar's PK Similarity to Reference Infliximab

October 22nd 2019

By Kelly Davio

In December 2018, biosimilar developer Amgen announced that it had submitted its proposed infliximab biosimilar, ABP 710, referencing Remicade, to the FDA for review. A regulatory decision is expected shortly, and last week, researchers published detailed results from the biosimilar’s phase 1 clinical study that evaluated the pharmacokinetic (PK) similarity of the biosimilar with its reference.

NeuClone Begins Phase 1 Trial of Proposed Ustekinumab Biosimilar

October 17th 2019

By The Center for Biosimilars Staff

NeuClone said Thursday that it has begun dosing participants with its proposed ustekinumab biosimilar, referencing Stelara, in a phase 1 trial.

Clinical Studies to Begin for Natalizumab, Aflibercept, and Bevacizumab Biosimilars

October 12th 2019

By The Center for Biosimilars Staff

While biosimilar stakeholders’ eyes have been on the recent launch of new products and on policy proposals that stand to impact these therapies, several new proposed biosimilar agents are making their way into clinical trials.

The Top 5 Biosimilars Articles for the Week of September 23

September 27th 2019

The Center for Biosimilars® recaps the top stories for the week of September 23, 2019.

Paper by European Regulators Foresees "Continuing Reduction in Clinical Data Requirements" for Biosimilars

September 24th 2019

By Kelly Davio

This month, Elena Wolff-Holz, MD, PhD, chair of the European Medicines Agency’s (EMA’s) Biosimilar Medicinal Products Working Party, together with coauthors from the EMA and the Federal Institute for Drugs and Medical Devices in Germany, published a new paper in which the team outlines the extent of clinical confirmation of biosimilarity, taken together with analytical and functional data, that is considered necessary for biosimilar drugs to be approved in Europe.

Time to Take a Science-Based View of Biosimilar Interchangeability, Paper Argues

September 20th 2019

By Kelly Davio

A team of authors points out that, given batch-to-batch variation of all biologics that can be enhanced by manufacturing changes, no batches of biologics can be considered identical to one another. However, “they may be considered essentially equal and therapeutically indistinguishable,” which points to a clinically acceptable range of structural heterogeneity for any biologic.

TOT Biopharm's Proposed Bevacizumab Biosimilar Shows PK Similarity to Avastin

September 5th 2019

By Kelly Davio

China-based drug maker TOT Biopharm is developing TAB008 as a biosimilar of the reference bevacizumab, Avastin. TOT has recently indicated that it is in the midst of a phase 3 clinical trial of the biosimilar, and last month, results of a phase 1 study of the biosimilar were published in Frontiers in Pharmacology.

Revance Gives Mylan Additional Time to Decide on Botox Biosimilar Development

August 28th 2019

By Kelly Davio

In a filing with the US Securities and Exchange Commission this month, Silicon Valley-based biotech company Revance Therapeutics said that it has entered into an amendment to a Collaboration and License Agreement with Mylan; the amendment extends the period of time Mylan has to decide whether to continue to develop and commercialize a biosimilar of Allergan’s onabotulinumtoxinA (Botox).

Time to Replace the Totality of the Evidence Approach to Biosimilars?

August 13th 2019

By Kelly Davio

Instead of the “totality of the evidence” approach to biosimilars, authors of a new paper propose a “confirmation of sufficient likeness” paradigm.