Bio-Thera has secured Chinese regulatory approval for Ashuli, the country's first golimumab biosimilar, expanding domestic biosimilar competition in rheumatoid arthritis and ankylosing spondylitis.

Brazil's health regulator has approved Henlius and Organon's pertuzumab biosimilar for certain HER2-positive breast cancer patients, marking the country's first authorisation of a biosimilar to this established oncology antibody.

The UK Medicines and Healthcare products Regulatory Agency has published new guidance allowing case-by-case assessment of certain non-clinical safety data generated outside the OECD Mutual Acceptance of Data framework for clinical trial applications.

The FDA has issued final guidance clarifying how prescription drug manufacturers should address companion apps and software in product labelling and regulatory submissions.

EU pharmaceutical legislation has moved closer to completion after member states backed the Council's first-reading positions on the regulation and directive forming the bloc's revised medicines framework.