There is no near-term relief in sight for generics makers, with erosion in the double digits to be expected next year. The key to overcoming a weak market? Complex generics and biosimilars, for those who have them, but even there success is not guaranteed. That, at least, is the view of Novartis exec Peter Goldschmidt, president of Sandoz US and head of North America for the Swiss drugmaker.
Analysts at Leerink got to speak with Goldschmidt recently, according to a note to clients today, and he gave them his perspective as the head of the world’s third-largest generics maker.
Sandoz is focusing its investments in biosimilars and more complex generics, where competition is not as intense. It also is using the 505(b)(2) pathway to offer products with improved clinical benefits or that are easier to administer than their branded counterparts, Leerink was told.
Novartis sees Zarxio, its biosimilar of Amgen's Neupogen and the first biosimilar approved by the FDA, eventually getting 40% of the market. Sandoz is already making inroads there. Worldwide Neupogen sales in 2016 were $765 million, down 27% from more than a billion dollars in sales the year before.
Goldschmidt told Leerink analysts and other investors that he believes “economics will ultimately rule the day,” forcing patients to switch from top-selling drugs like AbbVie’s Humira and Amgen’s Enbrel to biosimilars. Similarly, financial pressures are likely to influence physicians and hospitals to use biosimilars in treating cancer patients, as long as drugmakers can show there are no safety concerns.
But biosimilars are not surefire wins. Goldschmidt acknowledged that Sandoz has yet to figure out “a good way” to resolve the FDA’s concerns raised in a 2016 complete response letter for its biosimilar of Amgen’s Neulasta. He indicated the company expects to resubmit that biosimilar in 2019.
Sandoz is not the only drugmaker to have issues with a Neulasta biosimilar. In October, the FDA issued a manufacturing-related CRL to Mylan and Biocon for their copy. Several months before that, U.S. biotech Coherus BioSciences also got a CRL for its version.
The one area Goldschmidt thinks might be hard for generics makers to overcome for now is respiratory, where having just the right delivery device has been difficult for generics makers to produce. That insight comes even as Sandoz awaits FDA word on its Advair copy, which the agency began evaluating in June. Two other efforts, one from Mylan as well as one from Hikma and partner Vectura, have been sidelined by CRLs. .