Biosimilars/News
EMA accepts application for pegfilgrastim biosimilar from USV
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
Trastuzumab products from Celltrion Healthcare (Celltrion) and Biocon/Mylan have received approval in Europe and Brazil.
FDA approves follow-on insulin lispro Admelog
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
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
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
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
India-based biologicals specialist Biocon announced on 23 November 2017 the launch of its product Krabeva, a ‘similar biologic’ of bevacizumab, in India.
FDA approves trastuzumab biosimilar Ogivri
On 1 December 2017, the US Food and Drug Administration (FDA) approved its first trastuzumab biosimilar.
EMA accepts applications for pegfilgrastim and trastuzumab biosimilars from Biocon/Mylan
India-based biologicals specialist Biocon and US-based partner Mylan announced on 1 December 2017 that the applications for approval for their proposed pegfilgrastim (MYL‑1401H) and trastuzumab (MYL‑1401O) biosimilars have been accepted by the European Medicines Agency (EMA).
EC approval for trastuzumab biosimilar Ontruzant
South Korean electronics giant Samsung and biotechnology company Biogen Idec’s joint venture Samsung Bioepis announced on 20 November 2017 that it had received European Commission (EC) approval for its biosimilar trastuzumab product Ontruzant (SB3).
