Mylan gains clear pathway for Herceptin biosimilar
Mylan deal clears path for biosimilar copy of Roche’s Herceptin
Generic drugmaker Mylan said on Monday it had reached a settlement with Roche providing “a clear pathway” for the launch of its biosimilar version of the Swiss company’s top-selling breast cancer drug Herceptin in major markets.
Herceptin, which generated sales of 6.78 billion Swiss francs ($6.7 billion) in 2016, is one of the world’s most successful antibody drugs and has been a mainstay of Roche profits for many years.
But the Swiss company is now bracing for cut-price biosimilars as it looks to new medicines to drive future growth. Roche also faces biosimilar competition to its blood cancer drug Rituxan, with the first such rival launching in Europe last month.
Mylan’s settlement of its patent dispute with Roche will secure the generic drugmaker global licenses for its rival form of the medicine, which is known generically as trastuzumab.
The terms of the deal between the companies and the dates when Mylan will launch its biosimilar product in different markets were not disclosed.
Mylan and its Indian partner Biocon already sell biosimilar trastuzumab in 14 emerging markets and the medicine has been submitted for approval in Europe and the United States.
The complex nature of biological drugs, which are made inside living cells, means copies can never be exactly the same as the original, so regulators have devised an approval process based on products that are similar enough to do the job.
($1 = 1.0073 Swiss francs)
(Reporting by Ben Hirschler; editing by David Clarke)