Mylan and partner Biocon cleared another hurdle with their version of Roche’s breast cancer med Herceptin, one of the biggest biosim targets in the market.
To wrap up their patent dispute, Roche will grant the partners a global license to its blockbuster drug in return for Mylan's promise to back off of two challenges pending at the U.S. Patent and Trademark Office.
The potential launch date is under wraps and the biosimilar is still awaiting FDA approval, but the settlement brushes away “legal uncertainty” as Mylan prepares for its rollout. The license excludes Japan, Brazil and Mexico.
Earlier this year, the FDA accepted Mylan and Biocon’s Herceptin biosim application and set a regulatory decision deadline for Sept. 3, 2017. With that news, plus Monday’s settlement, Mylan says it could reach the lucrative U.S. market before any other competitor.
So far, biosims have hit the U.S. market with discounts of about 15% to the brands, but payers are hoping to squeeze even more savings out of their biologic drug budgets as the alternative versions pile into the market.
Mylan is already selling its Herceptin biosim in 14 emerging countries and has applications pending in the E.U. and elsewhere, according to its Monday release.
The Herceptin biosim is one of six biologics Mylan and Biocon have been developing together since the pair kicked off their collaboration back in 2009. The drug came under some controversy in India in 2014, when Roche sued on grounds the developers didn’t complete the full regulatory process. Just this month, a court in India sided with Mylan and Biocon, granting them marketing rights for the copycat.
Around the world, Herceptin brought in about $6.7 billion for Roche last year.
In addition to its version of Herceptin, Mylan has more than a dozen other biosims in development, a portfolio CEO Heather Bresch says is among the “industry’s broadest.”
But the generics-focused company isn’t alone in going after Roche’s blockbuster Herceptin sales. South Korea’s Celltrion has a candidate in the works, and Teva recently scooped up commercialization rights for that med.