Biosimilars
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].
EMA accepts first application for Chinese-made biosimilar HLX02
China-based Shanghai Henlius Biotech (Henlius) announced on 21 June 2019 that the regulatory submission for its proposed trastuzumab biosimilar (HLX02) had been accepted by the European Medicines Agency (EMA).
South Korea’s Celltrion to sell directly to Australia
In a successful month for Celltrion, the company announces plans to directly sell its anticancer biosimilars in Australia and begins a clinical trial for allergy treatment CT-P39.
Rituximab copy biological accepted for review in China
China’s National Medical Products Administration (NMPA), formerly the China Food and Drug Administration (CFDA), has accepted an application for approval of rituximab copy biological IBI301.
Real-world data on switching of etanercept biosimilars
Real-world and clinical data from different studies involving switching to etanerept biosimilars were presented at the European Congress of Rheumatology 2019 (EULAR 2019) [1].
