Biosimilars/News

FDA approves first follow-on insulin glargine treatment

Biosimilars/News | Posted 08/01/2016

The US Food and Drug Administration (FDA) announced on 16 December 2015 that it had approved Eli Lilly/Boehringer Ingelheim’s biosimilar version of Sanofi’s Lantus (insulin glargine) diabetes treatment.

FDA accepts application for pegfilgrastim biosimilar

Biosimilars/News | Posted 04/12/2015

Sandoz, the generics division of Novartis, announced on 18 November 2015 that its regulatory submission for its proposed pegfilgrastim biosimilar had been accepted by the US Food and Drug Administration (FDA).

Infliximab price wars

Biosimilars/News | Posted 04/12/2015

Merck has reportedly slashed the price of its blockbuster Remicade (Infliximab) in the UK in order to fight off growing competition from infliximab biosimilars.

Celltrion submits rituximab biosimilar application to EMA

Biosimilars/News | Posted 20/11/2015

South Korean biotechnology company Celltrion has, according to Business Korea, submitted a second biosimilar application to the European Medicines Agency (EMA).

Formycon starts phase III trial for ranibizumab biosimilar

Biosimilars/News | Posted 13/11/2015

German biosimilars companies Formycon and Bioeq announced on 7 October 2015 that they had initiated a pivotal phase III clinical trial with their candidate ranibizumab biosimilar (FYB201).

Boehringer Ingelheim stops biosimilar rituximab development

Biosimilars/News | Posted 30/10/2015

Germany-based Boehringer Ingelheim Pharmaceuticals (Boehringer Ingelheim) has reportedly halted clinical development for its biosimilar version (BI 695500) of Roche’s blockbuster leukaemia treatment Rituxan/MabThera (rituximab).

Insulin glargine biosimilar in US delayed until end 2016

Biosimilars/News | Posted 23/10/2015

Pharmaceutical majors Eli Lilly and Sanofi announced on 28 September 2015 that the two companies had agreed to end the legal dispute over biosimilar insulin glargine in the US and to discontinue similar disputes worldwide.

Baxalta and Momenta start phase III trial for adalimumab biosimilar

Biosimilars/News | Posted 16/10/2015

Baxalta – a spinoff company from Baxter International – and US-based biotechnology firm Momenta Pharmaceuticals (Momenta) announced on 5 October 2015 that they had started a phase III clinical trial for their adalimumab biosimilar (M923) in patients with chronic plaque psoriasis.

FDA accepts application for etanercept biosimilar

Biosimilars/News | Posted 09/10/2015

Sandoz, the generics division of Novartis, announced on 2 October 2015 that the US Food and Drug Administration (FDA) had accepted its application for its etanercept biosimilar (GP2015).