Sandoz' Biosimilar Etanercept On Its Way To EU Market
This article was originally published in Scrip
The EMA has accepted for review a biosimilar etanercept product from Novartis's Sandoz division. The biosimilar version of Pfizer's TNF-inhibitor Enbrel has been filed for use in all the indications detailed in Enbrel's label, including rheumatoid arthritis and psoriasis.
Sandoz believes its data package, including two pivotal clinical studies, a pharmacokinetic (PK) study in healthy volunteers and a confirmatory safety and efficacy study in patients with chronic plaque-type psoriasis (EGALITY), will provide clinical confirmation of similarity to the reference product established in extensive previous analytical comparability studies.
The filing acceptance is part of a renewed vigor in the European biosimilars space. Just last week Amgen began its foray into the EU biosimilars market by filing an approval application for ABP 501, a version of AbbVie's blockbuster MAb Humira (adalimumab). This was the company's first biosimilar filing in Europe, and was thought also to be the first EU filing for a biosimilar Humira.
But Sandoz is some way behind Samsung Bioepis UK Ltd., the joint venture between Samsung Biologics and Biogen, which received a positive opinion from CHMP for its biosimilar etanercept, Benepali, last month. A full approval should come within three months.
Formerly known as SB4, Benepali is the first etanercept biosimilar to be granted a positive opinion by the EMA's scientific committee – the CHMP – and will be the second biosimilar antibody product for autoimmune indications to gain EU approval, following the arrival of Celltrion's biosimilar of infliximab, Inflectra, earlier this year.
The EU was in the vanguard in establishing a biosimilars market, but approval activity in the area has waned slightly of late; the last two products to be authorized were Lilly/Boehringer Ingelheim's Abasaglar (insulin glargine; formerly Abasria) and Accord Healthcare's Accofil (filgrastim), both in September 2014.
Now, the market seems to be picking up again. Other recent activity includes Celltrion, which announced in November that it had applied for approval of its second biosimilar MAb, CT-P10, a biosimilar of Roche's Rituxan (rituximab), thought to be the first EU filing for biosimilar rituximab. As well as Sandoz' etanercept, the CHMP has five other biosimilars under review: CT-P10; Samsung Bioepis' SB2 (infliximab), which was accepted for filing in March 2015; two enoxaparin sodium products; and a human insulin.
As of November 2015, 19 biosimilar products were authorized for marketing in the EU, see table:
| Product | Company | Authorization Date | Reference Drug |
| Omnitrope (somatropin) | Sandoz | Apr 2006 | Genotropin (Pfizer) |
| Binocrit (epoetin alfa) | Sandoz | Aug 2007 | Eprex/Erypo (J&J) |
| Epoetin alfa Hexal | Hexal | Aug 2007 | Eprex/Erypo |
| Abseamed (epoetin alfa) | Medice | Aug 2007 | Eprex/Erypo |
| Silapo (epoetin zeta) | Stada | Dec 2007 | Eprex/Erypo |
| Retacrit (epoetin zeta) | Hospira | Dec 2007 | Eprex/Erypo |
| Biograstim (filgrastim) | CT Arzneimittel | Sept 2008 | Neupogen/Amgen |
| Tevagrastim (filgrastim) | Teva | Sept 2008 | Neupogen |
| Ratiograstim (filgrastim) | Ratiopharm | Sept 2008 | Neupogen |
| Filgrastim Hexal | Hexal | Feb 2009 | Neupogen |
| Zarzio (filgrastim) | Sandoz | Feb 2009 | Neupogen |
| Nivestim (filgrastim) | Hospira | June 2010 | Neupogen |
| Inflectra (infliximab) | Hospira | Sept 2013 | Remicade/J&J |
| Remsima (infliximab) | Celltrion | Sept 2013 | Remicade |
| Ovaleap (follitropin alfa) | Teva | Sept 2013 | Gonal-F/Merck Serono |
| Grastofil (filgrastim) | Apotex/Stada | Oct 2013 | Neupogen |
| Bemfola (follitropin alfa) | Finox Biotech | Mar 2014 | Gonal-F |
| Abasaglar (insulin glargine)* | Lilly/BI | Sept 2014 | Lantus/Sanofi |
| Accofil (filgrastim) | Accord Healthcare | Sept 2014 | Neupogen |
| * The product's name was changed from Abasria in December 2014. | |||
US Market
In the US, Sandoz launched its first biosimilar Zarxio on Sept. 3, and recently had its submissions for biosimilar etanercept and biosimilar pegfilgrastim accepted by the FDA. Sandoz says its pipeline contains several biosimilars across the various stages of development including five programs in Phase III clinical trials or registration preparation.