FDA Law Blog: Biosimilars

APRIL 25, 2024

This Revised Draft Guidance provides considerations for manufacturers, packers or distributors (dubbed “firms”) of prescription biological reference products, biosimilar products, and interchangeable biosimilar products presenting data and information about such products in promotional materials in a truthful and non-misleading way.

Biosimilars 59

Biosimilars Labelling Communication 59

Pharma Mirror

MARCH 31, 2022

As a response to increasing demand, Pipelinepharma will introduce biosimilar drugs into a separate category. The post Pipelinepharma marketplace records quadruple growth over a single year appeared first on Pharma Mirror Magazine. We are building upon our vision to become the world’s leading B2B pharma product platform.

Dosage 52

Dosage Biosimilars 52

pharmaphorum

MAY 21, 2021

It builds on the company’s four partnership projects: two with the generics and biosimilars firm Hikma, one with US biotech Inhibrix and another with an unnamed biosimilars partner. Eli Lilly, Novo Nordisk and there’s a group of biosimilar companies who already have a footprint in diabetes.”

Biosimilars 52

Biosimilars Diabetes 52

pharmaphorum

FEBRUARY 18, 2021

In late 2017, the FDA approved Admelog, Sanofi’s biosimilar of Humalog. They employed hundreds of new salespeople to detail doctors and hospitals, spent millions on TV and magazine ads and handed out masses of free samples. Eli Lilly’s Humalog compound and formulation patents expired in 2013 and 2014, respectively.

Prescription Filling 52

Prescription Filling Drug Pricing Biosimilars Compounding 52