Express Pharma

US DOJ permits six drug makers to share info about COVID-19 MAb treatments to expedite production

The approval granted through a business review letter from the Justice Department's antitrust division, however, has not allowed any discussion on the pricing of the treatments and production costs

0 681

The United States Department of Justice announced it will not challenge proposed efforts by Eli Lilly and Company, AbCellera Biologics, Amgen, AstraZeneca, Genentech, and GlaxoSmithKline to share information about manufacturing facilities and other information that could enable them to expedite the production of monoclonal antibody treatments that are determined to be safe and effective to treat COVID-19.

The letter explains that the demand for monoclonal antibodies targeting COVID-19 is likely to exceed what any one firm could produce on its own.  Moreover, waiting until regulators approve specific treatments before scaling up manufacturing might delay access to these potentially life-saving medicines by many months, which adversely could affect the nation’s efforts to fight COVID-19.  The Requesting Parties aim to address both problems by sharing information about their manufacturing facilities, capacity, raw materials and supplies that could be used to produce successful COVID-19 monoclonal antibody treatments subject to important safeguards and limits so that facilities can be ready to manufacture treatments once they prove safe and effective. Among other competitive safeguards, they have committed that they will not exchange information related to the prices of those treatments or the costs of inputs for or production of those treatments.  Their efforts likely will expedite and expand the overall production of monoclonal antibody treatments targeting COVID-19 in a way that is unlikely to lessen competition.

“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,” said Makan Delrahim, Assistant Attorney General.

The Requesting Parties submitted their business review request pursuant to the expedited, temporary review procedure detailed in the Joint Antitrust Statement Regarding COVID-19 issued on March 24 by both the Department and the Federal Trade Commission.  According to the Joint Statement, the Department will aim to resolve COVID-19-related business review requests like this one within seven calendar days of receiving all necessary information.

- Advertisement -