Tags : Coherus’

Biosimilars Insights+

Insights+ Key Biosimilars Events of January 2020

Biosimilars are developed to be highly similar versions of approved biologics in terms of safety, purity, and potency Biosimilar is expanding its footprints worldwide with multiple collaborations. In Jan 2020, Pfizer launched its two biosimilars [Ruxience (biosimilar, rituximab) & Trazimera (biosimilar, trastuzumab)] at lowest WAC in the US Our team at PharmaShots has summarized key […]Read More

Weekly Snapshot

PharmaShots Weekly Snapshot (January 13-17, 2020)

1. Arena’s APD418 Receives FDA’s Fast Track Designation to Treat Patients with Decompensated Heart Failure Published: Jan 17, 2020 | Tags: Arena, APD418, Receives, FDA, Fast Track Designation, Treat, Patients, Decompensated Heart 2. Charles River Collaborates with Fios Genomics for Bioinformatics-Driven Drug Discovery and Safety Assessment Published: Jan 16, 2020 | Tags: Charles River, Collaborates, Fios Genomics, […]Read More

Biosimilars Insights+

Insights+ Key Biosimilars Events of November 2019

Biosimilars are developed to be highly similar versions of approved biologics in terms of safety, purity, and potency. Biosimilars are expected to be a cost-effective alternative to high-priced branded biologics, offering significant and much-needed cost savings to both payers and patients. Hence physicians are likely to adopt biosimilars “a reference product to biologics” possessing similar […]Read More

Weekly Snapshot

PharmaShots Weekly Snapshot (November 04-08, 2019)

1. Triumvira’s TAC01-CD19 Receives FDA’s Fast Track Designation for R/R Diffuse Large B-Cell Lymphoma Published: Nov 07, 2019 | Tags: Triumvira, TAC01-CD19, Receives, FDA, Fast Track Designation, R/R, Diffuse Large B-Cell Lymphoma 2. Janssen Reports Submission of MAA to EMA for its Investigational Ebola Vaccine Regimen to Prevent Ebola Virus Disease Published: Nov 07, 2019 | Tags: […]Read More

Biosimilars Regulatory

Coherus’ Udenyca (pegfilgrastim-cbqv) Receives the US FDA Approval for Patients

Shots: Post EU Approval, Udenyca has received FDA approval on basis of non-inferiority data including its PK, PD and immunogenicity in 600 healthy patients, receiving myelosuppressive CT having cancer Udenyca novel pegfilgrastim-cbqv biosimilar, has received its EU approval on 21 Sep, 2018. In 2017, Pegfilgrastim had $4.5B sales worldwide Udenyca (formerly CHS-1701) is a PEGylated […]Read More