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The Ins and Outs of Contracting with Biosimilars

June 11, 2020

By Judy Hanover

As the market for biosimilars continues to grow, it’s become important for revenue management programs to address these new products in order to build competitive advantage.  Biosimilars are new to the US market, but they are far more established in Europe.  Biosimilars, like generics, are a version of the brand name drug, and provide patients with a pathway for more affordable treatment options.  On June 4, 2020, Model N presented a webinar featuring Ruven Remo Eul from IQVIA, and Roxana Santiago from Fresenius Kabi, that included an overview of the biosimilars market, discussed their experiences with contracting and tendering for biosimilars, and provided practical advice for those getting started. 

The biosimilar market in the US was opened with the Biologics Price Competition and Innovation Act (BPCI Act) of 2009 which laid the groundwork for the approval process for biosimilars.  While adoption has been slow in the US, reasonably competitive pricing and wider availability of biosimilars is finally leading to growth and additional legislation is likely to further reduce costs and lead to additional growth.  In the words of our speaker, Roxana Santiago, “biosimilars are on the horizon in the US, they present an excellent pathway toward providing more treatment options, offering increased access to patients and potentially lower healthcare costs through healthy competition.”

However, the numbers on adoption in the US can be dismal.  The speakers pointed out the example of infliximab, an immunosuppressive drug that treats autoimmune disorders.  It’s branded version, Remicade, has been marketed in the US since 1998, but the first biosimilar was not approved in the US until 2016.  There are now 4 approved biosimilars for infliximab in the US, but in the first 30 months following launch, US market share for the biosimilar only reached 8%.  This is in sharp contrast to Germany and the UK, where market share for the biosimilar went to 45% and 80%, respectively, at 30 months following launch.  National health systems supporting product adoption, competition and tendering all seem to be factors in the rapid European adoption.  Rebates figure heavily in the lack of adoption in the US, as our speakers demonstrated with several examples.

Many biosimilars are also specialty pharmaceutical products, a growing market that Santiago highlighted as also likely to lead to growth.  Specialty pharmaceuticals are generally defined as products used to treat chronic, high-cost, or rare diseases and can be injectable, infusible, oral, or inhaled medications.  While specialty pharmaceuticals can be chemical or biological, biosimilars represent a small portion of the products distributed by specialty pharmacies, a growing part of the supply chain.

 

Working with biosimilars is a new topic for most managed care and market access professionals, and many considerations including rebates, gross-to-net management and stakeholder management are important to this growing space.  These are all explored further in the webinar.  For more about the challenges of contracting with biosimilars, please visit our website to watch the complete webinar here.  If you’d like more information, please contact us at sales@modeln.com with any questions regarding the webinar or to set up a 15-minute intro call.

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