Just last month, the US FDA accepted Sandoz’s filing for biosimilar filgrastim, Zarzio. Sandoz is the first company to announce it has filed for approval under the biosimilars pathway created in the Biologics Price Competition and Innovation Act of 2009 (BPCIA). In the EU, Inflectra/Remsima™ (infliximab) became the world’s first biosimilar monoclonal antibody to be granted approval from an advanced and developed nations’ regulatory body. It has already had a limited launch in certain EU markets and a full roll-out is expected in early 2015. Companies developing biosimilars intended for regulated markets are presumably optimistic about these events which are helping to pave the way for future biosimilar development in advanced nations.
With the recent joint ACTRIMS-ECTRIMS 2014 meeting September 10-13, it was exciting to see key clinical data with both the new oral therapies, as well as the standard injectable therapies, some of which will be coming off patent as early as this year. The recent biosimilar regulatory activity occurring in the US and EU is finally allowing companies that are developing MS biosimilars to visualize a path to getting these drugs to market. Citeline has identified 14 companies that are involved in development of MS biosimilars. Based on the location and overall strategy of these companies, the majority of which are headquartered outside the US/EU; Citeline believes 5 companies have the potential to develop biosimilars possibly within the US or EU markets.
Although the new MS oral therapeutics have proven highly successful in treating patients, there is potential that MS biosimilars will provide stiff competition to the oral therapy market possibly due to a lower pricing structure, thus there is considerable interest in the timing of the first MS biosimilar launch in the US/EU.
Eight biosimilars for MS have already been launched, all outside of the US/EU, and 13 are currently still in development. These products include biosimilar versions of interferon β1a, interferon β 1b, alemtuzumab and natalizumab. Of the total 21 being developed, 8 different biologicals have been identified by Citeline for possible development in the US/EU, one of which has been reported as advancing to Phase III, interferon β1a by Harvest Moon Pharmaceuticals.
Regulatory agencies in both the US and EU are helping to shape a path forward, by providing guidelines for biosimilar development that allows for safety and efficacy to be established with drugs that some say carry significant risk in making them “similar”. Agencies are even focusing on specific targets in development guidelines, for example in 2013, the EMA issued specific guidelines for biosimilar interferons, which could highly impact the MS market. Based on these recommendations and strategic plans, Citeline predicts that biosimilar interferons could enter the US/EU market as early as 2016.
Note: Citeline defines a biosimilar as any copy of a biologic under development in any country.