Biosimilars
Mylan launches first trastuzumab biosimilar in Australia
Global generics firm Mylan NV (Mylan) and collaborating Indian pharmaceuticals giant Biocon Ltd (Biocon) have announced the launch of the first trastuzumab biosimilar in Australia. The drug can be used to treat breast and stomach cancers and will be marketed as Ogivri.
Samsung Bioepis starts phase III trial for eculizumab copy biological
Korea-based Samsung Bioepis (Samsung and Biogen’s joint venture) is carrying out a phase III clinical trial for a copy biological of Soliris (eculizumab), made by Alexion Pharmaceuticals (Alexion).
Australia approves three biosimilars in first half of 2019
Australia’s regulatory agency, the Therapeutic Goods Agency (TGA) has up until the end of June 2019 approved three biosimilars. The biosimilars approved in the country so far include two trastuzumab biosimilars and an adalimumab biosimilar.
Safety of SC form of infliximab biosimilar CT-P13
Positive results for Celltrion Healthcare’s (Celltrion) subcutaneous (SC) formulation of its infliximab biosimilar, CT-P13 (Remsima), have been presented at the European Congress of Rheumatology 2019 (EULAR 2019) [1].
FDA approves adalimumab biosimilar Hadlima
Korea-based biosimilars maker Samsung Bioepis (Samsung and Biogen’s joint venture) announced on 24 July 2019 that it had received approval from the US Food and Drug Administration (FDA) for its adalimumab biosimilar (SB5).
Korean firms to launch biosimilars in Japan despite trade tensions
Despite increasing trade tensions between Japan and Korea, two Korean firms have confirmed that they intend to move ahead with the launch of their darbepoetin alfa biosimilars in Japan in the second half of 2019.
Biosimilars applications under review by EMA – July 2019
The European Medicines Agency (EMA) is the body responsible for approval of biosimilars within the European Union (EU). A legal framework for approving biosimilars was established in 2003. Approval of biosimilars is based on an abbreviated registration process, which allows biosimilars manufacturers to provide a reduced package of information compared to originator drugs, provided they can prove ‘similarity’ to the originator or reference drug.
Positive phase III results for bevacizumab copy biological IBI305
Innovent Biologics (Innovent) has presented positive phase III results for its bevacizumab copy biological IBI305 at the 55th Annual Meeting of the American Society of Clinical Oncology (ASCO).
Extensive characterization of biosimilars: a pegylated filgrastim study
Pegfilgrastim, is a 38 kDa, pegylated form of filgrastim, with a 20 kDa monomethoxypolyethylene glycol (mPEG) molecule covalently bound to the N-terminal methionyl residue of filgrastim developed by Amgen. Attachment of the mPEG-moiety enables a longer half-life, that enables only once-per-cycle administration for the management of chemotherapy-induced neutropenia. This results in a much simpler treatment regime for patients. The biosimilar version of pegfilgrastim developed by Intas Pharmaceuticals, and marketed by Accord Healthcare under the brand name Pelgraz, is one of the first pegfilgrastim biosimilars to be approved for market authorization in the European Union (EU) [1].
Distinct suffixes will aid biosimilar competition, says new research
The differential naming of originator and biosimilar products supports accurate pharmacovigilance and promotes biosimilar uptake, finds a literature review recently published in GaBI Journal [1].
