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March 26, 2018

FDA’s biosimilars push: will interchangeability requirements change?

Several states in the US have passed legislation to support the substitution of biologic drugs with interchangeable biosimilars at the pharmacy level, the most recent among these being Michigan and South Dakota.

By GlobalData Healthcare

Several states in the US have passed legislation to support the substitution of biologic drugs with interchangeable biosimilars at the pharmacy level, the most recent among these being Michigan and South Dakota. Currently, around 38 out of the 50 states, as well as Puerto Rico, have passed similar bills, thus covering the majority of the US population. Although interchangeable biosimilars are not yet available in the US market, this push for legislation is in line with the latest political climate in the country, which urges the increased utilisation of these potentially cost-effective drugs.

In a recent speech, FDA Commissioner Scott Gottlieb emphasised the need to encourage biosimilar competition within the country. Despite the approval of nine biosimilars in the US (none of which are interchangeable), the market has seen very slow uptake of these drugs. This is mostly due to the current healthcare model in which manufacturers of the innovator biologics offer significant rebates to payers, which the biosimilar manufacturers are unable to match. As a result, health plans have a financial incentive to include the branded drugs in preferred tiers in their formularies, over their biosimilar counterparts. A nationwide stance by the US regulatory authorities for biosimilar promotion could go a long way in boosting biosimilar sales and help the US catch up with European countries, many of which have a fixed mandate on biosimilar use. For example, a non-US key opinion leader (KOL) interviewed by GlobalData indicated that physicians in their country had to fulfil a 30% quota for biosimilar prescriptions for general rheumatology outpatient practice.

Gottlieb also discussed plans for providing a more efficient roadmap for companies to demonstrate the interchangeability of biosimilars with their branded counterparts, since this would be an important step in promoting biosimilar use. Currently, substitution of an originator drug with a biosimilar can only occur when the latter has the FDA’s interchangeable designation in addition to the biosimilar designation. However, manufacturers have not been very keen to pursue this path, considering the cost and time commitment necessary for the additional clinical studies mandated by the FDA. According to E. Jay Wilusz Jr, founder, EJW Pharma Strategy, Washington who spoke to GlobalData reporter, Hannah Wilgar, it may cost a company $100m to do studies for FDA approval of a biosimilar on its own, but to make it an interchangeability study could cost an additional $100-$200m. In addition, a spokesperson from Humira biosimilar manufacturer, Amgen commented that the company urges the FDA to carefully consider its statutory considerations for interchangeability.

If manufacturers offer resistance towards conducting additional interchangeability studies, GlobalData believes that the FDA may be forced to reconsider its current stance and follow the example of its European counterparts. In the European market, there are no regulatory or legislative requirements to assign an interchangeability designation to biosimilars; rather, national regulatory agencies have themselves been endorsing the interchangeable use of these drugs under physician supervision. Given the FDA’s current advocacy for biosimilar use, such a scenario appears highly likely. At minimum, the regulatory agency will at least need to relax its requirements for interchangeability.

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GlobalData (2017). PharmaPoint: Crohn’s Disease – Global Drug Forecast and Market Analysis to 2026, September 2017, GDHC160PIDR

GlobalData (2017). PharmaPoint: Ulcerative Colitis –Drug Forecast and Market Analysis to 2025, January 2017, GDHC142PIDR

GlobalData (2017). Market Dynamic Forecast: Rheumatoid Arthritis – Global Drug Forecast and Market Analysis to 2025, November 2017, GDHC002FS

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