"Today, the U.S. FDA released its Biosimilar Action Plan(BAP), which outlines the Administration’s proposed next steps to help reduce the costs of healthcare by expediting the development of robust biosimilar competition and market penetration, while encouraging innovation and maintaining incentives for investing in future products. In remarks delivered at the Brookings Institute in conjunction with the BAP’s rollout, FDA Commissioner Scott Gottlieb, M.D., explained that the BAP is “an important piece of the Administration’s bold Blueprint to Lower Drug Prices and demonstrates the progress being made against the deliverables the President laid out.”
[...]
"During his comments on the BAP, Dr. Gottlieb raised concerns about the state of U.S. biosimilar competition, which he called “for the most part, anemic,” due to “rebate schemes,” “long-dated contracts … [that] lock up payors in multi-year contracts right on the eve of biosimilar entry,” and “patent thickets.”
While recognizing that some of the issues he was discussing were outside of the FDA’s purview, Dr. Gottlieb had some harsh words for any company that could be accused of trying to stave off biosimilar competition using unfair practices. He recalled that it took about two decades after enactment of the Hatch-Waxman Act to develop a robust generic drug market, but emphasized the urgency of developing biosimilar competition due to the costs of healthcare today. Dr. Gottlieb stated: “Sometimes it feels as if we’re seeing the biosimilars version of ‘Groundhog Day,’ with brand drug makers replaying many of the same tactics, and all of us being too susceptible to many of the same misconceptions about biosimilars’ safety and efficacy relative to originator biologics. We’re falling into some of the same doubts and policy constraints that were used to deter competition from generics in the years after the Hatch Waxman Act. But we’re not going to play regulatory whack-a-mole with companies trying to unfairly delay or derail the entry of biosimilar competitors. We’re not going to wait a decade or more for robust biosimilar competition to emerge.”
Dr. Gottlieb categorized the FDA’s plans into the following four “key strategies” to encourage biosimilar competition and market penetration: (1) “improving the efficiency of the biosimilar and interchangeable product development and approval process”; (2) “maximizing scientific and regulatory clarity for the biosimilar product development community”; (3) “developing effective communications to improve understanding of biosimilars among patients, providers and payors”; and (4) “supporting market competition by reducing gaming of FDA requirements or other attempts to unfairly delay market competition to follow-on products.”
https://www.bigmoleculewatch.com/2018/0 ... netration/
oczywiście tak jak wszyscy, zakładam że niebawem będziemy mieli bessę/załamanie na rynkach. przeanalizuj sobie co się w takich momentach dzieje ze wszystkimi aktywami, łącznie z metalami szlachetnymi. do tego czasu jednak wydaje mi się, że zloto ma potencjał na lekkie odbicie. choć osobiście wolałbym srebro, bardzo tanie w stosunku do złota.
