Development

Researchers Describe PopPK Model Developed for HLX01

November 26th 2019

By The Center for Biosimilars Staff

Because 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 2019

By Kelly Davio

Article

Last 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.

First Patients Dosed in Phase 3 Study of Natalizumab Biosimilar

November 21st 2019

By The Center for Biosimilars Staff

Article

On Monday, Polpharma Biologics announced that it has randomized the first patients in its phase 3 study of PB006, a proposed natalizumab biosimilar, and patients have begun to receive the study medication.

The FDA Will Review Samsung Bioepis' Proposed Bevacizumab Biosimilar, SB8

November 19th 2019

By Kelly Davio

Article

Samsung Bioepis announced Tuesday that the FDA has accepted for review the company’s Biologics License Application (BLA) for SB8, a proposed bevacizumab biosimilar referencing Avastin. The biosimilar developer submitted the BLA in September.

Pharma Panel Grapples With Drug Pricing, Real-World Evidence, and Creating Headroom for Innovative Therapies

November 12th 2019

By Kelly Davio

Article

During the FT Global Pharmaceutical and Biotechnology Conference, held this week in London, United Kingdom, a panel of executives from pharmaceutical companies, together with a scientist whose focus is on economics, discussed the increasingly challenging problem of paying for innovative therapies, particularly in a context of heightened political pressure around high drug costs.

At ACR, New Data for Amgen's Proposed Infliximab and Rituximab Biosimilars in RA

November 11th 2019

By Kelly Davio

Article

On Sunday, during the American College of Rheumatology (ACR)’s 2019 meeting, being held in Atlanta, Georgia, researchers reported on the safety and efficacy of the proposed infliximab biosimilar ABP 710 in a phase 3 study of patients with rheumatoid arthritis (RA). Researchers also reported on a phase 1 and 3 study of the proposed rituximab biosimilar, ABP 798, in patients with RA.

Coherus Secures Ranibizumab Biosimilar; Celltrion to Launch 1 Product Per Year; Bio-Thera Gaines Chinese Approval; Alvotech Forms Partnership

November 7th 2019

By Kelly Davio

Article

This week, multiple biosimilar developers announced major moves forward for their businesses, with Coherus BioSciences making a new acquisition, Celltrion reporting continued growth for its business, Bio-Thera Solutions gaining the first-ever approval of an adalimumab biosimilar from China’s National Medical Products Administration, and Alvotech and Stada entering into a 7-biosimilar partnership in Europe.

Novartis' Secukinumab Narrowly Misses End Point in Trial Against Adalimumab

November 1st 2019

By Allison Inserro

Article

Novartis Friday announced results from a head-to-head trial of its secukinumab (Cosentyx) versus adalimumab in patients with active psoriatic arthritis (PsA), saying its therapy missed statistical significance for its primary end point.

Q3 Numbers Show Biosimilar Momentum for Sandoz, Biogen, Pfizer, and Amgen

October 30th 2019

By Kelly Davio

Article

Biosimilars are beginning to gain momentum, even in the sluggish US market, evidenced by strong US and global sales reported this month by some of the top biosimilar players.

Could Results for Revance's Novel Botulinum Toxin Make a Biosimilar Botox Less Appealing?

October 29th 2019

By Kelly Davio

Article

Drug maker Revance Therapeutics has announced positive results from its SAKURA clinical program for its daxibotulinumtoxinA, a novel botulinum toxin type A that it hopes will compete with brand-name Botox, or onabotulinumtoxinA.