Biosimilars/News

Mylan and Biocon submit insulin glargine biosimilar to EMA

Biosimilars/News | Posted 02/12/2016

Generics giant Mylan Pharmaceuticals (Mylan) and Indian biosimilars major Biocon announced on 3 November 2016 that the regulatory submission for their proposed insulin glargine biosimilar had been accepted for review by the European Medicines Agency (EMA).

FDA accepts application for bevacizumab biosimilar

Biosimilars/News | Posted 25/11/2016

Biotech giant Amgen and its partner Allergan, announced on 15 November 2016 that the regulatory submission for its proposed bevacizumab biosimilar (ABP 215) had been accepted for review by the US Food and Drug Administration (FDA). The companies believe this submission is the first bevacizumab biosimilar application submitted to FDA.

EMA approves biosimilars of insulin glargine and teriparatide

Biosimilars/News | Posted 18/11/2016

The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) announced on 11 November 2016 that it had recommended granting of marketing authorization for an insulin glargine biosimilar and two teriparatide biosimilars.

Celltrion submits trastuzumab biosimilar application to EMA

Biosimilars/News | Posted 18/11/2016

South Korean biotechnology company Celltrion has, according to The Korea Herald, submitted another biosimilar application to the European Medicines Agency (EMA).

FDA accepts application for pegfilgrastim biosimilar from Coherus

Biosimilars/News | Posted 11/11/2016

Coherus BioSciences (Coherus) announced on 6 October 2016 that the US Food and Drug Administration (FDA) had accepted for review a Biologics License Application (BLA) for the company’s pegfilgrastim biosimilar candidate (CHS-1701).

Baxalta and Momenta part ways on adalimumab biosimilar

Biosimilars/News | Posted 04/11/2016

US-based biotechnology firm Momenta Pharmaceuticals (Momenta) announced on 27 September 2016 that it would regain rights to its candidate adalimumab biosimilar M923 from Baxalta, a spinoff company from Baxter International.

Biogen’s infliximab biosimilar gets UK launch

Biosimilars/News | Posted 28/10/2016

US biotechnology company Biogen has launched their biosimilar of blockbuster anti-inflammatory Remicade (infliximab) across the UK.

Pfizer to launch infliximab biosimilar Inflectra in US

Biosimilars/News | Posted 21/10/2016

Pfizer announced on 17 October 2016 that it will begin shipment of its monoclonal antibody biosimilar Inflectra (infliximab-dyyb) to the US in late November 2016.

EMA accepts application for trastuzumab biosimilar

Biosimilars/News | Posted 07/10/2016

Samsung Bioepis, which is a joint venture between South Korean electronics giant Samsung and biotechnology company Biogen, announced on 3 October 2016 that its regulatory submission for its proposed trastuzumab biosimilar (SB3) had been accepted for review by the European Medicines Agency (EMA). The company says the marketing application was submitted in August 2016.

FDA approval for Amgen’s adalimumab biosimilar

Biosimilars/News | Posted 30/09/2016

The US Food and Drug Administration (FDA) announced on 23 September 2016 that it had approved Amgen’s biosimilar version of AbbVie’s arthritis blockbuster Humira (adalimumab).