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The enactment of the US FDA Biosimilar 351(k) pathway in March 2010 has created uncertainty on many fronts. The innovator, biosimilar developer, FDA, and payer have spent years readjusting their strategies to prepare for the introduction of biosimilars in the US. Biomedtracker’s recent Biosimilars Special Report characterizes the biosimilar environment through a discussion of biosimilar development, regulatory pathways, reimbursement, and an analysis of US partnerships deals.


On the regulatory front, the Report begins by providing an evaluation of relevant analytical techniques that reveal structural variability between a biosimilar and its reference product. The US regulatory pathways to approval are then outlined and discussed as industry awaits FDA guidance regarding the “Interchangeable” designation. This designation is unique to the US and would bridge the gap between biosimilars and their generic cousins. The Biosimilar Special Report follows with a data driven discussion of the development timeline of biosimilars vs. standard biologics. Data has shown that the biosimilar 351(k) pathway does in fact offer an expedited pathway to approval through the reduction of Phase I and Phase III requirements, and forgone Phase II studies. Biomedtracker estimates a difference of 3.37 years for Phase I to Phase III development between biosimilars and standard biologics.


The Biosimilars Special Report also delves into the partnering landscape by analyzing its primary observation of deals concerning US biosimilars. Results first show that partnerships for US biosimilars were predominantly initiated during US preclinical development (56%), which confirms the advantage of early partnerships for biosimilar development. By partnering at the discovery phase, large cap companies can use their resources to focus on marketing, while small cap and foreign companies can focus on the discovery of biosimilars, thereby leveraging each company’s individual strengths. Of the seven biosimilars partnerships that began prior to US development, all have progressed to Phase III or an approval filing to the FDA. Not only can ex-US data build a stronger case for approval, but US companies can also utilize the experience of emerging market companies that are familiar with biosimilar development. It is therefore advantageous for companies to partner early in the US or while development is ex-US.


On the payer side, one-on-one interviews with reimbursement experts and industry research have revealed that payers are highly receptive to the introduction of biosimilars. Payers anticipate price and rebate discussions from the biosimilar for formulary inclusion and from the brand to maintain formulary access. One KOL interview suggested that price reduction of at least 20%, including rebates, would be required to make the formulary disruption worthwhile. Upon agreement, payers are prepared to use formulary management tools like tiering, step-therapy, and prior authorization to encourage the uptake of biosimilars.


For the complete report, visit BioMedTracker.

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