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July 24, 2020

US DoJ calls for increased Covid-19 monoclonal antibody production

The US Department of Justice (DoJ) has said that it will not challenge efforts by drugmakers to share information to scale up the manufacturing of monoclonal antibody treatments for Covid-19.

The US Department of Justice (DoJ) has said that it will not challenge efforts by drugmakers to share information to scale up the manufacturing of monoclonal antibody treatments for Covid-19.

The DoJ sent a letter to Eli Lilly, Amgen, AbCellera Biologics, AstraZeneca, Genentech and GlaxoSmithKline, noting that the demand for monoclonal antibodies against Covid-19 is likely to be higher than what one company could produce on its own.

In addition, waiting until regulatory approvals before manufacturing scale-up might delay access to the therapies by many months, in turn impacting the country’s response against Covid-19.

The companies requested authorisation to share information regarding their manufacturing facilities, capacity, raw materials and supplies for producing monoclonal antibody treatments for Covid-19.

This information sharing is subject to safeguards and limits, allowing facilities to be ready for manufacturing after the treatments demonstrated safety and effectiveness. The companies have agreed not to exchange information on the prices of these treatments.

This initiative could expand and boost the overall manufacturing capacity of the Covid-19 monoclonal antibody treatments while making it unlikely to lower competition.

Assistant Attorney General Makan Delrahim said: “This critical collaboration will help Americans get access to potentially life-saving therapeutics sooner than otherwise would be possible.

“It also will help preserve Americans’ ability to benefit from the free market competition that drives innovation and access to drugs in the biotech and pharmaceutical industry.”

In its letter to the manufacturers, the DoJ did not include Regeneron Pharmaceuticals, which is working on an antibody cocktail therapy against Covid-19.

Earlier this month, the US Biomedical Advanced Research and Development Authority (BARDA) and the DoJ awarded a $450m contract to Regeneron for the manufacture and supply of its antibody cocktail therapy.

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