Opening A Door To Biosimilars In The US
With the regulatory door ajar, companies across the pharmaceutical industry are vying to dominate the biosimilars space, despite the commercial risks.
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Three years into the ACA, the biopharma industry takes stock of its near-term wins and losses as the law’s critical expanded insurance coverage takes effect beginning in 2014. Pharma still isn’t sure whether the increase in covered lives from the exchanges will boost prescription sales enough to offset the rebates, taxes, and fees it agreed to pay out, or what kind of patients constitute this new market.
The lesson from first-generation biosimilars is that these aren't just small-molecule style copies. They require significant clinical and commercial support to overcome prescriber skepticism. For those lining up to tap into the next-generation opportunity, biosimilars represent a new kind of innovation, where the novelty lies in a drug's value-focused pricing, quality, cost-effective production, and in peripherals such as support-services and means of delivery. Although biosimilar market dynamics will vary from molecule to molecule, this emphasis on price and value rather than scientific breakthrough exemplifies a new definition of innovation in the biopharma sector.
FDA is open for business on biosimilars as it works out the specifics of the new review pathway. But for companies considering an entry into the space, two big questions still remain: Does a profitable market exist, and how conservative will FDA be on those initial approvals? Executives from across the biopharmaceutical industry weigh in during The RPM Report’s FDA/CMS Summit.