Development

Phase 3 Study Underway for Proposed Etanercept Biosimilar, SCB-808

January 2nd 2020

By Kelly Davio

China-based Clover Biopharmaceuticals announced this week that it has dosed the first patient in a phase 3 clinical study of SCB-808, a proposed etanercept biosimilar referencing Enbrel.

Eye on Pharma: Meiji and Dong-A Begin Phase 1 Trial of Proposed Ustekinumab Biosimilar

December 21st 2019

By The Center for Biosimilars Staff

Japan-based Meiji Seika Pharma and Republic of Korea-based Dong-A Socio Holdings announced this month that they have started a phase 1 clinical trial of DMB-3115, a proposed ustekinumab biosimilar referencing Stelara.

Lupin's Proposed Etanercept Biosimilar Shows Similarity to Enbrel, Has Lower Immunogenicity

December 16th 2019

By Kelly Davio

In May of 2018, drug maker Lupin announced that the European Medicines Agency would review its application for YLB113, a proposed etanercept biosimilar referencing Enbrel. This week, results of a phase 3 study of the biosimilar in patients with rheumatoid arthritis (RA) revealed the similarity of the product with its reference, and also demonstrated that the product has lower immunogenicity than the reference drug.

Outlook Therapeutics Reaches Agreement With FDA on Special Protocol Assessments for ONS-5010

December 14th 2019

By Kelly Davio

Outlook Therapeutics, formerly known as Oncobiologics, said this month that it has reached an agreement with the FDA on 3 special protocol assessments for clinical trials of ONS-5010, a formulation of bevacizumab intended to treat retinal diseases.

AffaMed Gets Chinese Clearance to Start Phase 3 Trial of Biosimilar Trastuzumab, SB3

December 11th 2019

By The Center for Biosimilars Staff

AffaMed Therapeutics announced this week that it has received a Clinical Trial Application (CTA) approval from Chinese regulators to conduct a phase 3 clinical trial of Samsung Bioepis’ biosimilar trastuzumab, SB3.

NeuClone's Proposed Trastuzumab Biosimilar Met Primary, Secondary End Points in Phase 1 Trial

December 6th 2019

By Kelly Davio

NeuClone did not specify whether it intends to move to a phase 3 clinical trial for the biosimilar. In fact, in its statement on the phase 1 results, the company noted that phase 3 trials are not required to achieve regulatory clearance.

Bio-Thera Solutions Gets Clearance to Start Phase 1 Trial of Ustekinumab Biosimilar

December 5th 2019

By Allison Inserro

Bio-Thera Solutions, a global biotechnology company based in Guangzhou, China, said this week that the China National Medical Products Administration (NMPA) has approved its Investigational New Drug (IND) application to initiate a phase 1 clinical study to compare the pharmacokinetics and safety of BAT2206, a proposed ustekinumab biosimilar, to the reference Stelara in healthy volunteers.

Lannett Announces Positive Results for Biosimilar Insulin Glargine

December 4th 2019

By The Center for Biosimilars Staff

Generic drug maker Lannett Company announced positive results from the beginning of a clinical program for its proposed biosimilar insulin glargine referencing Lantus.

The Top 5 Biosimilars Articles for the Week of November 25

November 29th 2019

The Center for Biosimilars® recaps the top stories for the week of November 25, 2019.

Are Microneedles the Key to Oral Biologic Delivery?

November 28th 2019

By The Center for Biosimilars Staff

The fact that biologic drugs are typically infused or injected poses numerous challenges, including discomfort for patients, instability under some storage conditions, and the generation of needle waste. Researchers have long sought a way to deliver biologics orally, and some teams have even reported progress toward the goal of delivering monoclonal antibodies in coated tablet forms. Now, researchers have reported in Nature Medicine that a luminal unfolding microneedle injector could be a feasible delivery device for biologic drugs like insulin.