Biosimilars

EMA accepts application for pegfilgrastim biosimilar from Coherus

Biosimilars/News | Posted 06/01/2017

US-based biosimilars developer Coherus BioSciences (Coherus) announced on 29 November 2016 that its application for approval for its proposed pegfilgrastim biosimilar (CHS 1701) had been accepted by the European Medicines Agency (EMA).

Positive phase III results for Boehringer’s adalimumab biosimilar

Biosimilars/Research | Posted 06/01/2017

Germany-based biologicals specialist Boehringer Ingelheim (Boehringer) announced on 26 October 2016 positive results from its pivotal phase III study of its candidate adalimumab biosimilar.

Bevacizumab biosimilar application submitted to EMA

Biosimilars/News | Posted 09/12/2016

Biotech giant Amgen and its partner Allergan announced on 2 December 2016 that they had submitted their application for approval for their proposed bevacizumab biosimilar (ABP 215) to the European Medicines Agency (EMA). The companies believe this submission is the first bevacizumab biosimilar application submitted to EMA.

Positive phase III results for Celltrion’s rituximab biosimilar

Biosimilars/Research | Posted 09/12/2016

Phase III studies of a rituximab biosimilar from Celltrion have, according to the company, shown that the biosimilar is ‘equivalent’ to Roche’s MabThera/Rituxan (rituximab).

Mylan and Biocon submit trastuzumab biosimilar to FDA

Biosimilars/News | Posted 09/12/2016

Generics giant Mylan Pharmaceuticals (Mylan) and Indian biosimilars major Biocon announced on 8 November 2016 that they had submitted the marketing application for their proposed trastuzumab biosimilar (Myl-1401O) to the US Food and Drug Administration (FDA).

Positive results for etanercept and bevacizumab biosimilars

Biosimilars/Research | Posted 09/12/2016

A phase III study of an etanercept biosimilar from Sandoz and a phase I study of a bevacizumab biosimilar from Boehringer Ingelheim have, according to the companies, shown the biosimilars to be ‘bioequivalent’ (bevacizumab) or have ‘equivalent’ safety and efficacy (etanercept) compared to their respective originator biologicals.

Biosimilar rituximab approved in South Korea

Biosimilars/News | Posted 02/12/2016

South Korean biotechnology company Celltrion announced on 17 November 2016 that the company had received approval for its rituximab biosimilar Truxima (CT-P10) from the Korean Ministry of Food and Drug Safety (MFDS, formerly the Korea Food and Drug Administration).

Biosimilars of abatacept

Biosimilars/General | Posted 02/12/2016

Last update: 28 April 2017

Abatacept is a modified antibody biological drug used to treat autoimmune diseases like rheumatoid arthritis, by interfering with the function of particular cells (T-cells) in the immune system. This action modifies the inflammation and immune activity which cause the symptoms of rheumatoid arthritis.

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).

Biosimilars help reduce the costs of cancer care

Biosimilars/Research | Posted 02/12/2016

The costs for cancer drugs have been increasing significantly in countries around the world. With the arrival of new therapies, the future of cancer care is exciting. But how will healthcare systems be able to pay for such innovations? In their commentary, Goldstein and co-authors discuss how biosimilars could help alleviate such challenges [1].