MGA Analysis of Potential Savings from Complex Generics Cited in Multiple Publications

This week, three publications in the healthcare policy and regulatory affairs industries referenced MGA’s recent report on the potential savings from accelerating US approval of complex generics. (Subscriptions required to view full text of articles.)

In Inside Health Policy, John Wilkerson wrote:

Speaking at an event put on by The Hill, Matrix Global Advisors CEO Alex Brill said he chose those seven products because they all have generic drug applications pending at FDA, and it’s reasonable to believe that FDA should have approved those products by now if regulatory bodies in Canada and Europe already approved them. The $1.3 billion estimated savings in the United States from those approvals was the central estimate in a range of savings calculations, Brill said.

Mari Serebrov of BioWorld stated:

[MGA’s] analysis highlighted the urgency in addressing how long it takes to get a complex generic approved in the U.S. Currently, “a significant number of important complex products are off patent but lack generic competition,” Brill said in the analysis. . . More complex products are expected to come off patent in the next few years. And the future will bring even more complex products as technology advances how drugs are administered.

The Pink Sheet senior writer Derrick Gingery had this to say:

The generics industry is making a broad case for review improvements in the area. A report commissioned by Teva found that the US could be losing $600m to $1.7bn per year in savings because a basket of seven complex drug products do not have approved generic competition.

The report, written by Matrix Global Advisors CEO Alex Brill, concluded that the annual savings estimates could already be realized if the currently pending ANDAs already were approved by the FDA.

Click here to read the full report.

Or, click here for a summary of the report.