After approval by the FDA, AVT03 is expected to be supplied in a single-dose prefilled syringe containing 60 mg in a 1 ml solution, as well as a 120 mg/1.7 ml solution in a single-dose vial.

The label expansion couls help J&J establish Tremfya as a successor to Stelara, which is now facing a growing biosimilar ...

South Korean biotech firms are targeting the $26 billion biosimilar market opening up as patents expire on more than 10 ...

Tendering emerged as the most effective strategy for reducing costs and increasing biosimilar uptake in the retail setting, ...

Overall, the study’s findings support the use of Amjevita and Imraldi as equally effective alternatives to Humira in the real ...

Alvotech acquires Xbrane’s R&D operations and the biosimilar candidate XB003. Xbrane retains some pre-clinical development programs, that it intends to commercialize, and will continue operating as a ...

Dr. Reddy’s Laboratories (RDY) and Alvotech (ALVO) announced that the U.S. FDA has accepted a Biologic License Application submission for AVT03. Read more here.

Steqeyma is indicated for the treatment of plaque psoriasis and psoriatic arthritis in adult and pediatric patients, as well ...

“The FDA's filing acceptance of Dr. Reddy's proposed denosumab biosimilar marks an important milestone in bringing this biosimilar medication to more patients throughout the U.S.,” said Milan ...

The inquiry is the latest effort by the European Commission and European countries to scrutinize potential antitrust behavior ...

China’s National Medical Products Administration (NMPA) approved the country’s first injectable teprotumumab biosimilar from Innovent Biologics Inc. under the brand name of Sycume (teprotumumab N-01) ...

Global biosimilar regulatory harmonization will be needed to reduce development costs and improve patient access, despite ...