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Σάββατο 9 Μαρτίου 2019

Top 10 drugs losing exclusivity in 2019



FiercePharma | Eric Palmer Mar 4, 2019

Pharma companies do their best to fight off patent expirations and generic competition as long as possible to protect their big moneymakers. But this year looks like the end of the line for many of the industry's top brands.
Pfizer’s Lyrica, GlaxoSmithKline’s Advair, Roche’s Rituxan, Gilead’s Harvoni and many other drugs are slated or expected to face new generic competition this year. Each has navigated a different path to the patent cliff, but they'll all end up delivering a heavy financial blow to their makers. 
For several companies included in the list, new generic pressure is already here. Amgen, for instance, started dealing with competition for Neulasta and Epogen last year, thanks to biosimilars from Mylan, Coherus and Pfizer. It remains to be seen just how much—and how quickly—biosimilars will hurt the profitable brands.
Other drugs face more uncertainty as they lose some of their IP protections. Enbrel, for instance, is another profitable drug that's nearing the cliff, but Amgen executives recently said their court fight against would-be biosim rival Sandoz will take a while to play out, so it's uncertain when the drug could face competition.
No bigger lineup of drugs is facing copycats for the first time than the one at Roche. Executives for the cancer giant have told investors they're expecting U.S. competition in 2019 for Rituxan, Herceptin and Avastin. Together, the trio of cancer megablockbusters pulled in more than $10 billion in the U.S. last year, Roche reported, representing a huge target for biosim companies.
Pfizer’s Lyrica and Glaxo’s Advair are two household names making an appearance in this year's ranking—again. Pfizer was slated to lose Lyrica exclusivity at the end of last year, but the FDA blessed the drugmaker with a 6-month extension for testing the drug in a set of pediatric patients. Glaxo, for its part, will finally face new Advair competition after numerous delays among would-be copycats. Mylan just recently scored FDA approval for its generic, and the company launched it in February.