Trial for Sandoz biosimilar hailed as ‘landmark’

Clinical data gathered for Sandoz’s biosimilar Etanercept (derived from Amgen and Pfizer’s Enbrel) was based from a “landmark” trial design in psoriasis in which over 500 patients switched from the original drug to the biosimilar.

The data from the EGALITY trial showed the Novartis unit’s biosimilar, filed in the US and EU, met primary endpoint of Psoriasis Area and Severity Index (PASI) 75 response, after 12 weeks.

The study’s aim was to compare the safety and the efficacy of the Sandoz biosimilar within Enbrel patients that suffered from moderate-to-severe chronic plaque-type psoriasis.
Biosimilars are cost effective near-replicas of biologic drugs – as they are proteins their amino acid sequence must be identical, but they may differ in other way. For instance, where sugar molecules are attached. Although the originator product can also vary over time, making it difficult when producing biosimilar.

Regulators in the EU and US allow biosimilars to have a truncated approval process, however they are still expensive to develop when compared to small molecule generics.
Professor Diamant Thaci, of the Comprehensive Center for Inflammation Medicine, University Medical School Schleswig-Holstein, Lubeck, said: “The EGALITY study is a landmark in clinical trial design. Data has been collected from over 500 patients in one year with multiple treatment switches where a patient receives either the biosimilar etanercept candidate or the originator product on a number of alternate occasions.”

“Data from this study, in addition to analytical, functional and pre-clinical studies, provides confidence in the comprehensive data package that is the basis for biosimilar medicine approval and use by healthcare practitioners.”

The data supporting switching from originator to biosimilar is key, as it provides doctors the confidence that all patients can be prescribed the biosimilar, not just those who have just started treatment.

In the second half of 2015, Sandoz’s biosimilar was accepted by the EMA and FDA for regulatory review.

It is seeking approval for all indications included in the label of the originator product, which is used to treat a variety of inflammatory conditions, including rheumatoid arthritis and psoriasis.

The company is also planning production of five biosimilars in oncology and immunology by 2020.

Biogen has already launched an Enbrel biosimilar in Europe. The original product has netted Amgen over $5 billion for the full year in 2015, up 14% from the year before, and is one of a group of key biologic drugs that are to come under pressure from biosimilar competitors in the near future.

IMS estimates that biosimilars could potentially save health systems in the US and EU up to $110 billion by the year 2020.




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