Oncology

Sandoz Resubmits BLA for Pegfilgrastim Biosimilar

April 3rd 2019

By Kelly Davio

Sandoz announced today that it has resubmitted to the FDA its Biologics License Application (BLA) for its proposed biosimilar pegfilgrastim.

Daiichi Sankyo to Accelerate BLA Submission for DS-8201

April 1st 2019

By Kelly Davio

Article

Daiichi Sankyo has announced that it is accelerating its Biologics License Application (BLA) for DS-8201, [fam-] trastuzumab deruxtecan for the treatment of patients who previously received ado-trastuzumab emtansine (Kadcyla), to the first half of 2019.

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.

Future of Biosimilars in Cancer Care Will Require a Balancing Act, Lyman Says

March 28th 2019

By Mary Caffrey

Article

The presentation at the National Comprehensive Cancer Network reviewed regulatory requirements and updates in the 2019 guidelines that affected biosimilars.

Eye on Pharma: Withdrawn BLA for Novel G-CSF Expected to Compete With Pegfilgrastim

March 27th 2019

By The Center for Biosimilars Staff

Article

Spectrum Pharmaceuticals has withdrawn its Biologics License Application (BLA) for eflapegrastim, a granulocyte colony-stimulating factor (G-CSF) therapy that the company had hoped to sell under the brand name Rolontis.

Biosimilar Filgrastim Shows How Value Can Evolve Over Time, Study Says

March 12th 2019

By Allison Inserro

Article

A recent meta-analysis of reference filgrastim’s (Neupogen) role in chemotherapy since its approval in 1991 shows how the definition of value has evolved over time as biosimilars for granulocyte colony-stimulating factors (G-CSF) entered the market.

No Difference in AEs Between Sandoz's Ziextenzo and Reference Pegfilgrastim

March 12th 2019

By Kelly Davio

Article

Among the data presented to regulators for the product’s approval were those arising from a phase 1 pharmacokinetic and pharmacodynamic study in healthy volunteers and those from 2 phase 3 studies in patients with breast cancer undergoing chemotherapy.

FDA Approves Pfizer's Trastuzumab Biosimilar, Trazimera

March 12th 2019

By The Center for Biosimilars Staff

Article

The FDA has approved Pfizer’s trastuzumab-qyyp (Trazimera), a biosimilar referencing Herceptin.

Fewer Than Half of Oncologists in ESMO Survey Report Using Biosimilars in Clinical Practice

March 11th 2019

By Kelly Davio

Article

Only 49.0% of prescribers reported that they use biosimilars in routine clinical practice, with more respondents from the Asia–Pacific region (56.3%) using these agents than their European counterparts (46.5%). The rate of use in the European group was lowest among UK prescribers (31.3%). A total of 24.1% reported that they do not use biosimilars in practice due to either a lack of approval or a lack of reimbursement in their respective countries.