Biosimilars/News

EC approval for bevacizumab biosimilar Mvasi

Biosimilars/News | Posted 02/02/2018

Biotech giant Amgen announced on 18 January 2018 that it had received European Commission (EC) approval for its biosimilar bevacizumab product Mvasi (ABP 215).

FDA accepts applications for adalimumab and trastuzumab biosimilars

Biosimilars/News | Posted 02/02/2018

Samsung Bioepis and Sandoz announced on 20 December 2017 and 16 January 2018, respectively, that the regulatory submissions for their proposed trastuzumab (SB3) and adalimumab (GP2017) biosimilars had been accepted by the US Food and Drug Administration (FDA).

EMA accepts application for pegfilgrastim biosimilar from USV

Biosimilars/News | Posted 26/01/2018

India-based biologicals specialist USV Biologics (USV) announced on 7 December 2017 that the application for approval for its proposed pegfilgrastim biosimilar has been accepted by the European Medicines Agency (EMA).

Trastuzumab biosimilars receive EMA and ANVISA approval

Biosimilars/News | Posted 26/01/2018

Trastuzumab products from Celltrion Healthcare (Celltrion) and Biocon/Mylan have received approval in Europe and Brazil.

FDA approves follow-on insulin lispro Admelog

Biosimilars/News | Posted 19/01/2018

Pharma giant Sanofi announced on 11 December 2017 that the US Food and Drug Administration (FDA) had approved its follow-on version of Eli Lilly’s Humalog (insulin lispro).

FDA approves biosimilar infliximab Ixifi

Biosimilars/News | Posted 12/01/2018

Pfizer announced on 13 December 2017 that the US Food and Drug Administration (FDA) had approved its biosimilar version of Johnson & Johnson and Merck’s Regicide (infliximab).

Humira deal could cost CMS US$1.48 billion

Biosimilars/News | Posted 10/11/2017

The settlement deal made between US-based biotech giant Amgen and pharma giant AbbVie regarding AbbVie’s blockbuster arthritis drug Humira (adalimumab) could cost the US Centers for Medicare and Medicaid Services (CMS) at least US$1.48 billion.

Amgen’s adalimumab biosimilar will only be launched in US in 2023

Biosimilars/News | Posted 20/10/2017

US-based biotech giant Amgen and pharma giant AbbVie announced on 28 September 2017 that they had reached a ‘global resolution’ ending all patent litigation regarding AbbVie’s blockbuster arthritis drug Humira (adalimumab).

Bevacizumab similar biologic launched in India

Biosimilars/News | Posted 12/01/2018

India-based biologicals specialist Biocon announced on 23 November 2017 the launch of its product Krabeva, a ‘similar biologic’ of bevacizumab, in India.