Biosimilars/News
Brazil approves first monoclonal antibody follow-on biological
Brazil’s medicines agency, the Brazilian Health Surveillance Agency (Agência Nacional de Vigilância Sanitária, ANVISA), announced on 27 April 2015 that it had approved its first follow-on biological medicine through ‘the development by comparability’.
Infliximab SEB launched in Canada
US-based generics major Hospira announced on 30 March 2015 the availability of its infliximab subsequent entry biologic (SEB) Inflectra in Canada, the country’s first SEB monoclonal antibody therapy.
US court rejects Amgen’s bid to block filgrastim biosimilar
On 19 March 2015, the US District Court for North California rejected US biotechnology giant Amgen’s request for a preliminary injunction blocking Sandoz, the generics division of Novartis, from launching its filgrastim biosimilar Zarxio (filgrastim-sndz).
Infliximab biosimilars tighten grip on European markets
The progress of biosimilars onto the European market continues apace with an announcement from Mundipharma that Remsima (infliximab biosimilar) is being launched in several major markets, including Germany and The Netherlands.
FDA approves its first biosimilar
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
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
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
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
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
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.
