Biosimilars/News

FDA approves its first biosimilar

Biosimilars/News | Posted 13/03/2015

The US Food and Drug Administration (FDA) announced on 6 March 2015 that it had approved Zarxio (filgrastim-sndz) injection, the first biosimilar ever to be approved in the US, for the five indications for which US-licensed Neupogen is approved. FDA found Sandoz’s Zarxio clinically comparable to Amgen’s blockbuster chemotherapy agent Neupogen (filgrastim), which is used to help prevent infections in cancer patients receiving chemotherapy.

Second Apotex biosimilar under FDA review

Biosimilars/News | Posted 13/03/2015

Canada-based Apotex announced on 13 February 2015 that the US Food and Drug Administration (FDA) had accepted for filing the company’s application for a biosimilar version of Amgen’s Neupogen (filgrastim).

Hospira launches infliximab biosimilar in major European markets

Biosimilars/News | Posted 06/03/2015

Injectable generics specialist and biosimilars maker Hospira announced on 16 February 2015 that it was launching its infliximab biosimilar, Inflectra, in several major European markets. Inflectra, a treatment for inflammatory diseases such as rheumatoid arthritis and inflammatory bowel disease, will now be marketed in 24 European countries, nearly doubling its presence across Europe.

FDA delays meeting to evaluate infliximab biosimilar

Biosimilars/News | Posted 27/02/2015

The US Food and Drug Administration (FDA) has postponed a meeting of its Arthritis Advisory Committee, which was to discuss an infliximab biosimilar.

Accord launches biosimilar filgrastim in Europe

Biosimilars/News | Posted 27/02/2015

Generics company Accord Healthcare (Accord) has announced the launch of their first European approved biosimilar Accofil (filgrastim), indicated for the treatment of chemotherapy induced neutropenia.

Hospira and Pfenex to collaborate on ranibizumab biosimilar

Biosimilars/News | Posted 20/02/2015

US-based injectables specialist Hospira and US biotechnology firm Pfenex announced on 10 February 2015 that they had entered into an agreement to exclusively develop and commercialize for worldwide sales PF582 (ranibizumab), Pfenex’s leading biosimilar candidate.

FDA advisers to consider infliximab biosimilar

Biosimilars/News | Posted 13/02/2015

The US Food and Drug Administration (FDA) revealed in a Federal Register publication on 10 February 2015 that it has asked advisers to review a second biosimilar application.

Torrent licenses three ‘similar biologics’ from Reliance

Biosimilars/News | Posted 13/02/2015

Torrent Pharmaceuticals (Torrent) announced on 25 December 2014 that it had made an exclusive licensing agreement with fellow Indian drugmaker Reliance Life Sciences (Reliance) for the marketing of three ‘similar biologics’ in India.

FDA advisers recommend approval of filgrastim biosimilar

Biosimilars/News | Posted 09/01/2015

US Food and Drug Administration (FDA) advisers have voted unanimously to recommended approval for Sandoz’s biosimilar version of Amgen’s Neupogen (filgrastim), a development that could make complex biological therapies more readily accessible in the US.