Sandoz granted novel biosimilars approval
The approval authorises the interchangeability of denosumab biosimilars in the US to treat primary and secondary bone loss.
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The approval authorises the interchangeability of denosumab biosimilars in the US to treat primary and secondary bone loss.
A new formulation of an antibody drug has been authorised via a process from the Medicines and Healthcare products Regulatory Agency (MHRA) that enables “considerably shorter” approval timelines.
The biomanufacturing facility has been designed to help Amgen meet its target of carbon neutrality in all its operations by 2027, according to the company.
With demonstrated benefit in anti-tumour activity and overall survival in patients with small cell lung cancer, Tarlatamab could provide a new third-line option, a Phase II study suggests.
Paul England, senior counsel in Taylor Wessing's Patents Group, examines the burgeoning influence of the Unified Patent Court and unitary patents within the life sciences sector. How popular are unitary patents and do they have potential to reshape European life sciences patent litigation?
The US FDA has approved Amgen’s Wezlana (ustekinumab-auub) as the first biosimilar to reference blockbuster drug Stelara (ustekinumab).
With over $7 billion sales predicted by 2029, AstraZeneca’s Tagrisso is set to lead the lung cancer small molecule treatment market, according to GlobalData.
GlobalData has shared research on how the loss of exclusivity of AbbVie’s Humira (adalimumab) is shaping the biosimilars market.
Experts at Amgen have highlighted a micro sequential injection (µSI) process analyser and automatic assay preparation platform (A2P2) as an autonomous process analytical technology (PAT) platform to enable rapid testing and release of biopharmaceutical products.
First-line immunotherapy blinatumomab significantly improved survival in babies with acute lymphoblastic leukaemia in an international trial.
A report reviewing the state of sterile oligonucleotide drug processing has recommended ways to aid development of terminal sterilisation processes.
AMJEVITA™, the first biosimilar to Humira® is now available in the US, based on four years of real-world experience in over 300,000 patients.
The Robert A. Winn Diversity in Clinical Trials Award Program has been pledged $8 million over the next four years by Amgen.
Subin Baral, EY Global Deals Leader, Life Sciences, recounts the global M&A trends in 2022 and predicts activity for 2023 in EY’s 2023 M&A Firepower report.
The US biosimilars market experienced dramatic growth in 2022, particularly for therapies helping to treat oncological and inflammatory conditions, Amgen suggested in a recent report.