Development

Sandoz Enrolls First Patient in Study of Proposed Denosumab Biosimilar, GP2411

July 22nd 2019

By Kelly Davio

Sandoz announced today that it has enrolled its first patient in a combined phase 1 and phase 3 study of its proposed denosumab biosimilar versus EU-authorized Prolia.

FDA Releases Updated Draft Guidance on Population PK

July 16th 2019

By The Center for Biosimilars Staff

Article

The FDA has released updated draft guidance on population pharmacokinetics (PK). The update follows draft guidance originally put forth by the agency in 1999.

Celltrion to Start Phase 1 Trial of Omalizumab Biosimilar, CT-P39

July 16th 2019

By Kelly Davio

Article

Republic of Korea–based drug maker Celltrion announced this week that it is launching its first clinical trial of CT-P39, a proposed biosimilar omalizumab referencing Xolair. The company says that it plans to enter phase 3 trials in the first half of 2020 and has plans to commercialize the biosimilar by 2022.

When Analytical Characterization of a Biosimilar Reveals Shifts in Quality Attributes of a Reference Product

June 21st 2019

By Kelly Davio

Article

The attributes for the N-glycan profile, FcγRIIIa binding activity, and relative antibody-dependent cell-mediated cytotoxicity (ADCC) activity for the reference trastuzumab resulted in reduced ADCC and FcγRIIIa binding activities.

Eye on Pharma: NeuClone to Start Phase 1 Trial of Ustekinumab Biosimilar

May 16th 2019

By The Center for Biosimilars Staff

Article

NeuClone announced yesterday that it will initiate a phase 1 clinical trial of its ustekinumab biosimilar, referencing Stelara, in the second half of 2019. Ustekinumab, a human interleukin-12 and -23 antagonist, is approved by the FDA to treat plaque psoriasis, psoriatic arthritis, and Crohn disease.

Phase 1 Study of Proposed Infliximab Biosimilar Shows High PK Similarity to Remicade

April 13th 2019

By The Center for Biosimilars Staff

Article

Genor Biopharma, a China-based drug developer that is engaged in development of a number of biosimilars, has completed a phase 1 study of a proposed infliximab biosimilar, GB242, referencing Remicade.

Study Reports on Physiochemical and Biological Characterization of Rituximab Biosimilar RTXM83

April 12th 2019

By The Center for Biosimilars Staff

Article

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.