TrialSite News recently posed the question to readers: could it be the case at the very time the public is actively concerned about drug price increases that the exact opposite is occurring? In yet another major piece of news, generic drug producer Mylan, fresh with Food and Drug Administration (FDA) approval of generic Advair in hand offers the advanced asthma drug at 70% discount!
Advair was developed by UK pharmaceutical giant GlaxoSmithKline (GSK). It is a blockbuster. In 2017 alone, it raked in $4.19 billion. Sales have been good in the U.S. because approximately 26 million people with asthma. Worldwide up to 358 million are afflicted with the ailment. It represents a very large market.
Advair is used to treat asthma and chronic obstructive pulmonary disease (COPD) by decreasing inflammation and opening the lung’s airways. With the launch of Mylan’s Wixela™ Inhub™ (fluticasone propionate and salmeterol inhalation power, USP), it introduces the first generic of Advair Diskus® at 70% less than brand.
A 70% discount is dramatic. The market will undoubtedly respond favorably assuming the product works comparably well. The FDA is a champion. During the approval press release, Anna Abram, FDA Deputy Commissioner for Policy, Planning, Legislation and Analysis noted “we are committed to advancing new guidance for sponsors to make the development of generic versions of complex products more efficient, and we’re prioritizing review of many applications covering proposed generic complex products for which a generic has not yet been approved.” Translation—the FDA wants to really help generic producers’ delivery generic products to market.
TrialSite News has commented often on the dramatic transformation of the U.S. healthcare market. Over 120 million individuals are covered by government insurance alone. Public payers use tax payer dollars to pay for medicines. Tax payers feel that they share often and a lot already. With certainty we predict intensifying downward pressure on pricing—not of course in all segments—but in many and more to come. The branded biopharmaceutical business models most certainly will continue to factor this dynamic competition into their business models.