Biosimilars
Positive phase III results for adalimumab and trastuzumab biosimilars
Phase III studies of an adalimumab biosimilar from Momenta Pharmaceuticals (Momenta) and a trastuzumab biosimilar from Pfizer have, according to the companies, shown that the biosimilars are ‘equivalent’ compared to their respective originator biologicals.
Naming affects pharmacists’ perceptions and dispensing of biosimilars
A study of pharmacists, carried out jointly by the Academy of Managed Care Pharmacy (AMCP) and the Hematology/Oncology Pharmacy Association (HOPA), found that pharmacists had a preference for distinguishable names. However, the study also found that using the same names for interchangeable biologicals would make pharmacists more likely to dispense biosimilars [1].
EMA accepts application for pegfilgrastim biosimilar from Coherus
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
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
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
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
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
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
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
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.
