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Norway's discount on infliximab: A litmus test for biosimilar expansion in Europe?

20 March 2014 Federica Benassi

Looking at recent developments in the European pharmaceutical markets, biosimilars seems to have a major potential for growth - and conversely represent a significant threat to branded biologics. In January, the South-Korean biosimilar manufacturer Celltrion secured the first position for its product Remsima in the national tender in Norway for national supply of the monoclonal antibody infliximab. The company gained the first position by offering a discount of 39% compared to the price of the reference product - Merck & Co/Johnson & Johnson's Remicade.

Biosimilar versions of infliximab secure major discounts in Norway and Poland The price difference is impressive, particularly when compared to the average price difference between reference products and biosimilars that ranges between 15-30 %, according to IHS estimates.

Similar to Norway, Poland has included from the 1 January 2014 Remsima to the national reimbursement list with a discount of 32% compared to Remicade (source: IHS POLI).

In addition, new opportunities for commercialisation of biosimilars infliximab will open in February 2015. In fact, Merck & Co/Johnson & Johnson have been successful in delaying patent expiration in a number of western European countries due to the combination of paediatric patent extension and supplementary protection certificates which have pushed back patent expiration by a few months. However, opportunities for Celltrion to replicate its Norway and Poland success across Europe may be affected by policy makers and regulators' attitude towards biosimilars in different European markets.

Norway emerges as pioneer in biosimilars markets access Norway certainly represents a breeding ground for biosimilars uptake as the Norwegian Medicines Agency (NoMA) is proactively encouraging a substitution culture in the country. In particular, clinical studies have been promoted by NoMA to demonstrate Remicade and Remsima/ Inflectra's interchangeability - namely, the possibility to switch back and forth between the reference product and the biosimilar - a practice that is not currently allowed in any European country.

Furthermore, in 2010 Amgen brought NoMA to court following the Agency decision to include Amgen's neutropenia treatment Neupogen in the automatic substitution list with other biosimilar versions of filgrastim. The court embraced Amgen's arguments based on the fact that biosimilars drugs cannot be considered copies of the originator.

And finally, in France, with the approval of the Social Security Finance Bill for 2014, the doors have opened to biosimilars substitution at pharmacy level in treatment-naïve patients; however, these examples remain "black swans" in the European arena as no other market has explicitly allowed for pharmacy-level substitution and other European regulators seem to be reluctant to loosen provisions on biosimilars.

New patent expirations for mAb drugs expected in Europe in 2014 Having said that, biosimilars expansion looks to be on the agenda in Europe. The discount proposed in Norway is definitely above and beyond the average reductions we have seen in Europe so far and shows biosimilars manufacturers' willingness to take the European market by storm and boost biosimilars uptake in European markets. Furthermore, biosimilars and the respective reference product share the same international non-proprietary name (INN) in Europe. Therefore, originator manufacturers are called to adopt pricing strategies able to fight off competition from biosimilars in countries where tenders are called by INN.

In addition, the approaching patent cliff for major biologic drugs will see a number of originator companies losing their patent exclusivity over the next five years opening new opportunities for new biosimilars approval filings to the European Medicines Agency. In particular, in 2014 Roche's cancer treatments Rituxan (rituximab) and Herceptin (trastuzumab) will lose patent protection and we may see biosimilars versions of these drugs approaching the market in the medium term.

However, as biosimilars tend to be prescribed exclusively to patient that are just starting the course of treatment (i.e., treatment-naïve patients), their potential expansion in volume terms will certainly be slower in the medium run compared to generic drugs. Furthermore, biosimilars success may also depend on the attitude of the prescribers towards these drugs. In fact, in markets where prescription targets for biosimilars are not in place, reluctance of prescribers to recommend biosimilars may significantly affect the uptake of these drugs in the market.

We have done some extensive research on biosimilars and non-innovator biologics in emerging markets. Access a sample of that research and learn more.



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