With a record number of FDA biosimilar approvals in 2024, CMOs specializing in biologics can expect to see higher biosimilar volumes, according to GlobalData.
The company warned that if the executive order goes into effect, Roche’s ability to invest $50 billion in its U.S. R&D and manufacturing sites will be in question.
CEO Bill Anderson said that the company has “considerable” production capabilities in both the U.S. and Europe but has no immediate plans to shift them.
CEO Christophe Weber said that the investment is not a new strategy and reflects the position of the U.S. as the world’s leading market for biopharma innovation.
The announcement comes after President Trump signed an executive order aimed at expediting the approval process for domestic pharmaceutical manufacturing facilities.
The move comes as demand for peptide and oligonucleotide therapeutics continues to accelerate, particularly in light of projected growth in the obesity drug market.
The CDMO will develop and qualify analytical methods, optimize the formulation, scale up production, and manufacture a cGMP batch of KAD101 to support clinical studies.
Under the partnership, Mirai will tap Thermo Fisher’s developmental and current Good Manufacturing Practice services, as well as commercial manufacturing capabilities.
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