Just one day after the FDA warned Mylan it would issue a second thumbs-down on its generic asthma drug Advair—causing investors to push the stock down 5%—the agency granted the company a small but important win. Mylan scored one of two approvals of the first generic versions of sublingual Suboxone, which is widely used to treat opioid addiction.
But the launch of the product, a film strip that combines buprenorphine and naloxone, will present a host of challenges for Mylan. The FDA also approved a generic version of the product made by India’s Dr. Reddy’s, which promptly announced (PDF) plans to launch four doses of it in the U.S. Mylan has not yet disclosed its launch plans and did not immediately respond to a query about its strategy from FiercePharma.
Suboxone once brought in $2 billion in sales a year for its patent holder, U.K.-based Indivior. Both generics makers would be entering the U.S. market "at risk," because Indivior is wrapped up in patent litigation with them in an ongoing attempt to hold off generic competitors. Mylan had previously reached a settlement with Indivior, agreeing to hold off launching its generic until 2023.
The FDA positioned the approvals of generic Suboxone as a major step forward in the Trump administration’s plan to lower drug prices. “The FDA is taking new steps to advance the development of improved treatments for opioid use disorder, and to make sure these medicines are accessible to the patients who need them,” said FDA Commissioner Scott Gottlieb in a statement. “That includes promoting the development of better drugs, and also facilitating market entry of generic versions of approved drugs to help ensure broader access.”
Indivior has come under fire for its strategies to block generic competition to Suboxone. In 2016, it was sued by 35 states when it discontinued the original tablet version of the drug and pushed doctors to switch patients to the film strip—a move that critics called anticompetitive. At the time, generic tablets were entering the market and threatening Indivior’s market share.
The Federal Trade Commission has been investigating Indivior for alleged antitrust issues related to holding off generic competition. And in May, the California Department of Insurance subpoenaed the company for information about Suboxone, including documents related to the question of whether patients can become dependent on the drug. Meanwhile, Indivior is rapidly losing its market share to generic tablet versions of the drug. Suboxone’s market share fell from 61% in 2016 to 57% last year, the company reported.
The approvals of generic Suboxone film come in the midst of an ongoing debate in Washington, D.C., over the Creates Act, which would punish branded drugmakers for scheming to prevent generics manufacturers from getting samples of the products they need to make their inexpensive copies. Earlier this week, the Senate Judiciary Committee voted to advance the bill.
As for Mylan, its ability to get a generic Suboxone on the market could help diversify a product mix that’s facing plenty of challenges. The company recently won approval for Fulphila, the first biosimilar version of Amgen’s blockbuster Neulasta, but that product is expected to face competition from Coherus' version of the same drug, which the FDA is now reviewing. Pricing pressure in the U.S. continues to be a concern, too.
That said, some analysts are optimistic about Mylan’s potential to launch as many as nine products with significant revenue opportunities by the end of 2019. They include that Advair generic, which could win approval within three months, provided Mylan can quickly address the FDA’s concerns. Mylan expects to receive a complete response letter from the agency on June 27, after which it will get to work solving what the company said in a statement amounts to “minor deficiencies.”
Bernstein analyst Ronny Gal said in a note to investors that he’s optimistic, even if all of Mylan’s near-term product launches only achieve “conservative success.” The pipeline has plenty of biosimilars and complex generics, he wrote, so “there is enough diversification there that even with some individual product delays … the cumulative effect should be enough for consistent solid growth.”