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.

Aurobindo, that last year signed a deal with U.S. drugmaker MSD to manufacture one of their biologics products at its subsidiary Theranym Biologics, has agreed on a contract to roll out a single ...

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 ...

Although more research is needed in pediatric patients, biosimilars could improve treatment access and reduce costs.

Comparable efficacy results were observed at week 78 after switching to the biosimilar from the reference product (secondary endpoint). Safety, pharmacokinetic, and immunogenicity data demonstrated ...

“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 ...

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[1] An interchangeable biosimilar is a biosimilar that meets ... has been reported to occur after administration of omalizumab products. Anaphylaxis has occurred as early as after the first ...

The report delivers a comprehensive analysis of global biologics sales. Covering cancer antibodies, non-TNF inflammatory mAbs, biosimilars, gene therapy, RNA-based drugs, and more, the report provides ...

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OMLYCLO® (omalizumab-igec) is the first and only omalizumab biosimilar approved by the FDA Regulatory approval for ...