Development

Study Reports on Physiochemical and Biological Characterization of Rituximab Biosimilar RTXM83

April 12th 2019

By The Center for Biosimilars Staff

While the United States awaits the launch of its first biosimilar rituximab, other regulatory jurisdictions have biosimilars referencing Rituxan already available on the market. One such product, available in South America, the Middle East, and Africa, is RTXM83, developed by drug maker mAbxience.

Reference Infliximab and CT-P13 Show Similar Physicochemical and Functional Stability

April 11th 2019

By The Center for Biosimilars Staff

Article

Between reference infliximab and biosimilar infliximab CT-P13 (Inflectra, Remsima), different recommendations exist for the clinical solutions. Recently, a research article, published in BioDrugs, assessed and compared the stability of the solutions prepared from the originator and the biosimilar using a set of characterization methods in line with International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use recommendations.

Celltrion Completes Enrollment of Phase 3 Trial of CT-P17, Gives Update on Subcutaneous CT-P13

April 4th 2019

By Kelly Davio

Article

Korean drug maker Celltrion announced that it has completed enrollment in its phase 3 clinical trial of CT-P17.

Equivalent PK/PD, Noninferior Immunogenicity Reported for Pfizer's Biosimilar Filgrastim and Its Reference

March 30th 2019

By The Center for Biosimilars Staff

Article

Pfizer’s biosimilar filgrastim, Nivestym, was approved by the FDA in July 2018 and launched in the United States in October 2018. Among the data on which the approval was based were 3 comparative clinical assessments of the pharmacokinetics (PK), pharmacodynamics (PD), immunogenicity, and safety of the biosimilar versus the US-licensed reference filgrastim (Neupogen) in both male and female healthy volunteers. Results from these studies were reported in full last week.

Are We Ready for Tailored Clinical Programs for Biosimilars?

March 29th 2019

By Kelly Davio

Article

During the second day of the Medicines for Europe 17th Biosimilar Medicines Conference, held March 28-29 in Amsterdam, the Netherlands, a panel of experts discussed the current state of the regulatory landscape and considerations for tailoring clinical programs in the years ahead.

An Expert View on Immunogenicity and Biosimilars

March 22nd 2019

By Kelly Davio

Article

During the BioTech Pharma third annual Biosimilars and Biologics Summit, held March 21 to 22 in Porto, Portugal, João Gonçalves, PhD, group leader and principal investigator at Research Institute for Medicines in Portugal, discussed ways in which biosimilar developers can anticipate—and avoid—issues with immunogenicity.

More Than a Decade After the First Biosimilar, the Regulatory Landscape Is Increasingly Complex

March 21st 2019

By Kelly Davio

Article

During the first day of the BioTech Pharma third annual Biosimilars and Biologics Summit, held March 21 to 22 in Porto, Portugal, Barbara Valenta-Singer, MD, chief medical officer of biosimilars at Fresenius-Kabi SwissBioSim, gave an expert perspective on the past 10-plus years of experience with biosimilars in the European and US contexts.

Positive Results for Celltrion's Proposed Biosimilar Bevacizumab in Phase 1 Trial

March 15th 2019

By The Center for Biosimilars Staff

Article

According to the investigators, their data support the further development of CT-P16 as a bevacizumab biosimilar.

Alvotech Enrolls First Patient in Phase 3 Study of Proposed High-Concentration Biosimilar Adalimumab

March 13th 2019

By Kelly Davio

Article

Drug maker Alvotech announced today that it has begun enrollment for its phase 3 clinical study of AVT02, a proposed adalimumab biosimilar referencing Humira. Alvotech says that it has enrolled its first patient, and it plans to enroll approximately 400 total participants at 30 European sites in the study of AVT02 versus the reference product in patients with chronic plaque psoriasis.

Eye on Pharma: Mylan Could Develop the First True Botox Biosimilar

March 2nd 2019

By The Center for Biosimilars Staff

Article

Mylan revealed in its recent fourth quarter 2018 earnings call that it had an initial advisory meeting with the FDA regarding a proposed biosimilar onabotulinumtoxinA, referencing the brand-name Botox.