February 5th 2025
Of the 118 biologics losing exclusivity over the next decade, only 10% have biosimilars in development, meaning a vast majority of biologics have no pipeline, which limits savings potential for the health care system.
Roman Drai Discusses Geropharm's Biosimilar Pursuits
May 12th 2020Roman Drai, MD, PhD, deputy director and head of clinical operations at Geropharm, discussed Geropharm’s budding biosimilar pipeline and the company’s international pursuits during the World Biosimilar Congress USA 2020 at the Festival of Biologics USA in San Diego, California.
Researchers Suspect Link Between Missing Gut Microbes, Ulcerative Colitis
February 25th 2020The 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.
Spectrum Says Its Novel G-CSF Drug Will Be Reviewed by FDA
January 4th 2020In 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.
Eye on Pharma: Meiji and Dong-A Begin Phase 1 Trial of Proposed Ustekinumab Biosimilar
December 21st 2019Japan-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 2019In 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 2019Outlook 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 2019AffaMed 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 2019NeuClone 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 2019Bio-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.
Are Microneedles the Key to Oral Biologic Delivery?
November 28th 2019The 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.
Researchers Describe PopPK Model Developed for HLX01
November 26th 2019Because stand-alone pharmacokinetic (PK) studies are usually designed to focus on intrinsic and extrinsic factors that have a high potential to affect drug exposure, they leave other possible interactions unstudied; population PK (popPK) analysis allows for an assessment of multiple factors that are not otherwise evaluated in healthy volunteers and allows for a larger number of individuals to be included.
Developing PD Biomarkers Could Streamline Biosimilar Development
November 21st 2019Last month, writing in a perspective piece in Clinical Pharmacology and Therapeutics, a group of authors further explored the rationale for developing and using pharmacodynamic (PD) biomarkers in biosimilar development.