Bio-Thera had entered into an exclusive licensing agreement with STADA Arzneimittel AG to commercialize BAT2506 in the European Union (UK), the United Kingdom (UK), Switzerland, and selected other ...

The European Medicines Agency’s (EMA) human medicines committee (CHMP) recommended four novel medicines for approval at its ...

The EMA recommended the highest number of approvals in the last 15 years in 2024, giving the nod to 114 drugs. That is amongst the highest number in the 30 years of the agency’s existence, said ...

CHMP Adopts Positive Opinion for Aflibercept, Pegfilgrastim Biosimilars:  On January 30, 2025, the European Medicines Agency (EMA) Committee ...

Bio-Thera Solutions Inc. (688177:SH), a commercial-stage biopharmaceutical company developing a pipeline of innovative ...

European Medicines Agency (EMA), in close collaboration with the European Commission, has established a standard procedure ...

Sarfaraz K. Niazi, PhD, argues that regulatory agencies should eliminate redundant clinical efficacy testing for biosimilars, ...

Celltrion received recommendations of approval from the European drug regulator for four of its biosimilar products ... of the European Medicines Agency (EMA) recommended for market authorization ...

The two products, both manufactured by Amgen, are aflibercept biosimilars Pavblu and Skojoy. Both biosimilars are indicated ...

Hyderabad: CuraTeQ Biologics s.r.o., a step-down subsidiary of Aurobindo Pharma Limited, has announced that the Committee for ...

"The acceptance of the EMA MAA for BAT2506 marks another milestone for Bio-Thera as it is the first golimumab biosimilar developed by a Chinese company to be submitted to the EMA for approval ...