Development

BiosanaPharma Reports Positive Phase 1 Results for Omalizumab Biosimilar

April 9th 2020

By Tony Hagen

With positive phase 1 study results and a manufacturing process that may cut costs significantly, BiosanaPharma hopes its omalizumab biosimilar candidate will have an edge on the worldwide market.

Early-Stage Study Details Similarity of Bevacizumab Biosimilar to Avastin

March 13th 2020

By Skylar Jeremias

Even as the first bevacizumab biosimilar gained approval for marketing in China, data emerged from a phase 1 pharmacokinetic study comparing the biosimilar with its reference product (Avastin).

Researchers Suspect Link Between Missing Gut Microbes, Ulcerative Colitis

February 25th 2020

By Skylar Jeremias

The study compared the stool samples of patients with ulcerative colitis (UC) with patients with familial adenomatous polyposis. Both groups may have colectomies, but only the patients with UC have inflammation that may return even after surgery.

Remove Roadblocks to Streamline the Biosimilar Approval Process, Industry Veteran Says

February 14th 2020

By Tony Hagen

Sarfaraz K. Niazi, PhD, a pharma industry veteran and consultant for biosimilar makers, discusses ins and outs of the approvals process that cause frustration and unnecessary expense.

Animal Study of Secukinumab Biosimilar Gene Therapy Yields Promising Results

January 25th 2020

By Deana Ferreri, PhD

The study examined secukinumab biosimilar lentivirus-based gene therapy, which showed successful and prolonged expression of the recombinant antibody in rats.

Spectrum Says Its Novel G-CSF Drug Will Be Reviewed by FDA

January 4th 2020

In late December, Spectrum Pharmaceuticals announced that the FDA has accepted for review a Biologics License Application for eflapegrastim, a novel drug that could, if approved, compete with existing granulocyte colony-stimulating factor (G-CSF) therapies and their biosimilars.

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.