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2017 Biosimilar Approvals in Europe

The European biosimilar market has expanded at record pace in 2017.  The EMA approved marketing of sixteen biosimilar products referencing seven different innovator biologic products.  For five of the innovator products – AbbVie’s Humira, Biogen/Genentech’s Rituxan, Genentech’s Herceptin, Eli Lilly’s Humalog, and Eli Lilly’s Forsteo – no biosimilar was previously approved in Europe. 

Biosimilars Approved in Europe as of December 2017 (1)

Biosimilar Trade Name Marketer Active Substance Reference Drug Year of Approval
Epoetins
Abseamed Medice epoetin alfa Eprex/Erypo 2007
Binocrit Sandoz epoetin alfa Eprex/Erypo 2007
Epoetin Alfa Hexal Hexal epoetin alfa Eprex/Erypo 2007
Retacrit (2) Hospira epoetin zeta Eprex/Erypo 2007
Silapo Stada epoetin zeta Eprex/Erypo 2007
Filgrastims
Accofil Accord filgrastim Neupogen 2014
Filgrastim Hexal Hexal filgrastim Neupogen 2009
Grastofil (3) Apotex filgrastim Neupogen 2013
Nivestim Hospira filgrastim Neupogen 2010
Ratiograstim Ratiopharm filgrastim Neupogen 2008
Tevagrastim Teva filgrastim Neupogen 2008
Zarzio (4) Sandoz filgrastim Neupogen 2009
Follitropins
Bemfola Finox follitropin alfa GONAL-f 2014
Ovaleap Teva follitropin alfa GONAL-f 2013
Growth Hormones
Omnitrope (5) Sandoz somatropin Genotropin 2006
Insulins
Abasaglar (6) Eli Lilly insulin glargine Lantus 2014
Lusduna (7) Merck insulin glargine Lantus 2017
Insulin lispro Sanofi Sanofi insulin lispro Humalog 2017
Low-Molecular Weight Heparins
Inhixa Techdow Europe AB enoxaparin sodium Clexane 2016
Thorinane Pharmathen S.A. enoxaparin sodium Clexane 2016
Monoclonal Antibodies
Amgevita/Solymbic (8) Amgen adalimumab Humira 2017
Cyltezo (9) Boehringer Ingelheim adalimumab Humira 2017
Imraldi Samsung Bioepis adalimumab Humira 2017
Flixabi (10) Samsung Bioepis infliximab Remicade 2016
Inflectra (11) Hospira infliximab Remicade 2013
Remsima (11) Celltrion infliximab Remicade 2013
Rixathon/Riximyo (12) Sandoz rituximab MabThera 2017
Truxima/Blitzima/ Ritemvia/Rituzena (13) Celltrion rituximab MabThera 2017
Ontruzant (14) Samsung Bioepis trastuzumab Herceptin 2017
Parathyroid Hormone Fragment
Movymia STADA Arzneimittel teriparatide Forsteo 2017
Terrosa Gedeon Richter teriparatide Forsteo 2017
Fusion Proteins
Benepali Samsung Bioepis etanercept Enbrel 2016
Erelzi (15) Sandoz etanercept Enbrel 2017

(1) Three additional biosimilars were approved by the EMA but subsequently had their authorizations withdrawn.

(2) An FDA advisory committee recommended approval of Hospira’s U.S. biosimilar application in May 2017, but the application was rejected by FDA in June 2017.

(3) A biosimilar application to market in the United States was accepted for review by FDA but has not been approved.

(4) Approved in the United States as a biosimilar under the Biosimilar Price Competition and Innovation Act of 2009 (BPCIA) with the trade name Zarxio.

(5) Approved in the United States under the 505(b)(2) pathway.

(6) Original EU trade name was Abasria; it was approved in the United States under the 505(b)(2) pathway with the trade name Basaglar and launched in the United States in December 2016.

(7) In July 2017, Lusduna received tentative approval in the United States under the 505(b)(2) pathway.

(8) Approved in the United States in September 2016 with trade name Amjevita.  Amgevita and Solymbic are different trade names for the same monoclonal antibody.

(9) Approved in the United States in August 2017 as a biosimilar under the BPCIA.

(10) Approved in the United States in April 2017 as a biosimilar under the BPCIA under trade name Renflexis.

(11) Inflectra has been approved in the United States as a biosimilar under the BPCIA.  Inflectra and Remsima are different trade names for the same monoclonal antibody.

(12) Rixathon and Riximyo are different trade names for the same monoclonal antibody.  A biosimilar application to market in the United States has been accepted by FDA.

(13) Celltrion’s MabThera biosimilar was first approved in Europe in February 2017 under the name Truxima.  Additional marketing authorizations under the trade names Blitzima, Ritemvia, and Rituzena (previously Tuxella) were granted in July 2017.  A biosimilar application to market in the United States has been accepted by FDA.

(14) Samsung Bioepis announced in November that it had received marketing authorization in Europe. 

(15) Approved in the United States as a biosimilar under the BPCIA.

CHMP Issues Positive Opinions
Two additional biosimilars, Amgen/Allergan’s Mvasi and Celltrion’s Herzuma, have received favorable opinions from EMA’s Committee on Medicinal Products for Human Use (CHMP) and may soon be approved in Europe.  Mvasi, a biosimilar of Genentech’s Avastin (bevacizumab), received a favorable recommendation from CHMP on November 9, 2017.  Mvasi was approved as a biosimilar in the United States in September 2017.  Celltrion’s Herzuma, a biosimilar of Genentech’s Herceptin (trastuzumab), received a positive opinion from CHMP on December 14, 2017.  If, as anticipated, the European Commission follows the recommendation of CHMP, Mvasi and Herzuma likely will be approved in Europe in the coming months. 

Pending Biosimilar Applications in Europe
Eleven additional biosimilar applications are under evaluation by the EMA as of December 2017: three applications for biosimilars of AbbVie’s (adalimumab), one application for a biosimilar of Sanofi’s Lantus (insulin glargine), six applications for biosimilars of Amgen’s Neulasta (pegfilgrastim), one application for a biosimilar of Janssen’s Remicade (infliximab) and four applications for biosimilars of Genentech’s Herceptin (trastuzumab).

The six pending applications for biosimilars of Amgen’s Neulasta (pegfilgrastim) are particularly notable, since EMA has rejected a number of the previous applications for pegfilgrastim biosimilars and no pegfilgrastim biosimilars have been approved to date.  Indeed, two of the currently pending applications for pegfilgrastim biosimilars are resubmissions of rejected applications.  Sandoz’s resubmitted application was accepted for review in October 2017, while Mylan/Biocon’s resubmitted application was accepted for review in November 2017.  Other pending applications include applications from Coherus, Spain’s Cinfa, and Indian pharmaceutical manufacturer USV. 

EMA is also reviewing Mylan/Biocon’s application for Ogivri, a biosimilar of Genentech’s Herceptin (trastuzumab).  Ogivri was approved as a biosimilar in the United States on December 1, 2017.  However, Mylan/Biocon’s application for marketing approval for Ogivri in Europe, like its application for its pegfilgrastim biosimilar, ran into problems last summer after a European inspection of Biocon’s manufacturing facility.  Like the pegfilgrastim application, the Ogivri application was withdrawn in August 2017 but resubmitted in November.

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2017 has been a record-setting year for biosimilar approvals in Europe.  Although the first biosimilars to the European market were approved in 2006 and 2007, the number of approved biosimilars has doubled in the past two years.  These approvals have expanded the market into new therapeutic areas and new classes of biologics. 

Categories: Biosimilars, BPCIA, EMA
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