Biosimilars

Sanofi insulin biosimilar close to European entrance

05-May-2020 By Ben Hargreaves

Sanofi’s insulin aspart biosimilar receives positive opinion from the EMA’s CHMP.

Biocon Biologics' biosimilar sites cleared by FDA

16-Apr-2020 By Ben Hargreaves

The company announces that an inspection by the US FDA into its two sites had now been closed.

US FDA closes inspection of Biocon’s insulin facility

02-Apr-2020 By Ben Hargreaves

The company announces that the problems raised by the FDA in February have been cleared.

Insulin designated biologic in ‘landmark moment’

24-Mar-2020 By Ben Hargreaves

Manufacturers can now apply to the US FDA for the approval of biosimilars to insulin products.

Biocon insulin facility hit with FDA Form 483

27-Feb-2020 By Ben Hargreaves

Biocon’s Malaysia facility received a Form 483 with three observations, after a pre-approval inspection.

FDA finalizes definition of biologics, prepping entry of insulin biosimilars

25-Feb-2020 By Ben Hargreaves

US FDA announces updated definition of a biologic medicine, ahead of insulin, and other products, transitioning to become licensed as biologics.

Hired and Retired: Appointments at the cutting edge

24-Feb-2020 By Ben Hargreaves

This month there have been a number of changes in the leadership of organizations working on biosimilars and in the advanced therapeutic space.

AbbVie details US biosimilar defense ahead of arrival of Humira copies

18-Feb-2020 By Nick Taylor

AbbVie commits to replicating global Humira defense strategy in US when biosimilar rivals arrive.

Merck to focus on Keytruda, separating out biosimilar business

12-Feb-2020 By Ben Hargreaves

The newly separate business will include women’s health, legacy brands, and biosimilar units, as the main part of the business retains oncology, vaccines, hospital and animal health.

Amgen looks to biologics manufacturing tech to cut carbon emissions

11-Feb-2020 By Nick Taylor

Amgen commits to next-generation biologics manufacturing technologies in attempt to reduce environmental impact.

FDA raises concerns on ‘anti-competitive’ biosimilar practices

10-Feb-2020 By Vassia Barba

Anti-competitive actions by companies hamper uptake of biosimilars, the US FDA suggests, and announces a series of actions that will be taken against them.