In the first part of a two-part interview, Paz Vellanki of Precision for Medicine explains what sponsors should bring to early FDA meetings and how manufacturing and assay readiness can delay rare disease trials.
|Articles|February 12, 2008
Campaign Promotes Regulation of Follow-On Biologics
Author(s)BioPharm International Editors
Insmed Inc. (Richmond, VA), has launched an education campaign about the importance of establishing a regulatory pathway in the US for large-molecule protein-based drugs, known as follow-on biologics (FOBs), biosimilars, or biogenerics.
Advertisement
Insmed Inc. (Richmond, VA), has launched an education campaign about the importance of establishing a regulatory pathway in the US for large-molecule protein-based drugs, known as follow-on biologics (FOBs), biosimilars, or biogenerics.
The scientific, regulatory, and legal framework for the approval of small-molecule generic drugs is well developed, and a regulatory system for approving FOBs was established in Europe in 2006. However, there is currently no regulatory pathway for FOBs in the US.
Insmed is currently developing a portfolio of FOBs and intends to initiate clinical trials for its first two FOBs in 2008. Members of Insmed's biologics team have worked on over 50 therapeutic proteins. With their protein-based drug development backgrounds, coupled with the company’s FDA-approved protein manufacturing facility, and clinical and regulatory expertise, Insmed is positioning itself as an initial entrant into the US FOBs market.
An estimated $10 billion worth of biologic drugs are expected to come off patent by 2010, with an additional $10 billion by 2015.
Advertisement
Related to this article
FDA clears the IND for Biolojic Design’s BD200, an AI-designed Trop2/Nectin-4 multibody ADC; Blackstone Life Sciences agrees to provide Pfizer up to $1.5 billion to develop its monthly GLP-1 receptor agonist berobenatide; and enGene Therapeutics plans a year-end BLA for detalimogene voraplasmid in BCG-unresponsive non-muscle invasive bladder cancer.
Detalimogene voraplasmid produced a 56% complete response rate in BCG-unresponsive bladder cancer, with an estimated 43% of responses lasting a year.
FDA has cleared Biolojic Design’s IND for BD200, a bispecific antibody-drug conjugate targeting Trop2 and Nectin-4 whose arms can each bind either target. A global Phase 1 study in solid tumors is expected to begin in the coming weeks.
Blackstone Life Sciences will fund up to $1.5 billion of development costs through 2028 for Pfizer’s monthly GLP-1 receptor agonist berobenatide, in exchange for milestone payments tied to approval and sales. Pfizer keeps full control of the program.
Gene-corrected nula-cel freed all 3 RESTORE patients from transfusions, with sickle hemoglobin below 20% in the 2 followed for over 6 months.
Beam Therapeutics’ base-edited cell therapy risto-cel meets its primary endpoint in the BEACON sickle cell disease trial, Amgen’s CD40L antagonist dazodalibep reduces systemic disease activity in the phase 3 OASIZ-301 Sjögren’s disease trial, and ImvivaBio’s allogeneic CD19/BCMA CAR-T CTA313 sustains lupus remission through 12 months.
Matt Truppo, Richard Jaenisch, and Brian Drapeau examine AI's impact on drug success, human oversight, data governance, and biopharma's future.
Advertisement
Advertisement
Trending on BioPharm International
1
Blackstone to Provide Pfizer Up to $1.5 Billion for Monthly GLP-1 Berobenatide Development
2
ImvivaBio’s Dual-Target Allogeneic CAR-T Sustains Lupus Remission Through 12 Months
3
Updates on Simtra BioPharma Solutions’ Bloomington Capacity Expansions
4
The BioPharm Brief: An AI-Designed Multibody ADC Enters the Clinic, Blackstone Backs Pfizer’s Monthly GLP-1, and enGene Readies a Bladder Cancer BLA
5