Biosimilars
Efficacy and safety of bevacizumab biosimilar ABP 215
Authors from the US and Europe report data from a phase III study comparing the clinical efficacy and safety of the bevacizumab biosimilar ABP 215 (Mvasi) with originator bevacizumab Avastin in patients with advanced non-squamous non-small cell lung cancer (NSCLC) [1].
Key considerations for biosimilars in the US
Key considerations regarding biosimilars for payers in the US are discussed in a recent review [1]. The authors explore factors promoting the uptake of biosimilars, interchangeability and naming considerations, and challenges to uptake.
Biocad advancing its non-originator biologicals in Russia
Russian biotechnology company Biocad has started an eculizumab study and has also registered its non-originator biological (BCD 057) in Russia.
ESMO survey highlights need for education and alignment
The results of a survey carried out by the European Society for Medical Oncology (ESMO) on biosimilars understanding in oncologists have highlighted the need for education and worldwide alignment [1].
Sandoz resubmits pegfilgrastim biosimilar to FDA
Sandoz, the generics division of Novartis, announced on 3 April 2019 that the regulatory submission for its proposed pegfilgrastim biosimilar (LA-EP2006) had been accepted by the US Food and Drug Administration (FDA).
Phase III clinical trials started for adalimumab biosimilars
Phase III clinical trials have been started for adalimumab biosimilars from Alvotech and Celltrion.
Samsung Bioepis invalidates Herceptin patent in Korea
Samsung Bioepis has won a patent invalidation suit against Roche’s Herceptin in Korea.
Biosimilars of pertuzumab
Pertuzumab is a monoclonal antibody that inhibits the dimerization of human epidermal growth factor receptor 2 (HER2) with other HER receptors, which prevents them from signalling in ways that promote cell growth and proliferation.
How can EU policymakers access the potential of biosimilars
Policymakers in Europe should introduce a long-term, multi-stakeholder framework to realize the full potential of off-patent biologicals and biosimilar drugs, according to the results of a series of roundtable discussions held with clinicians, government bodies and industry representatives [1].
Japanese approval for Lupin’s etanercept biosimilar
Indian generics manufacturer Lupin Pharmaceuticals (Lupin) announced on 26 March 2019 that its joint venture YL Biologics and Lupin (through its Japanese subsidiary, Kyowa Pharmaceutical Industry) had received approval from Japan’s medicines regulatory agency, the Pharmaceuticals and Medical Devices Agency (PMDA), for its etanercept biosimilar YLB113 in Japan.
