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|
|Epoetin Alfa Hexal||Hexal||epoetin alfa||Eprex/Erypo||2007|
|Retacrit (2)||Hospira||epoetin zeta||Eprex/Erypo||2007|
|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|
|Cyltezo (9)||Boehringer Ingelheim||adalimumab||Humira||2017|
|Flixabi (10)||Samsung Bioepis||infliximab||Remicade||2016|
|Truxima/Blitzima/ Ritemvia/Rituzena (13)||Celltrion||rituximab||MabThera||2017|
|Ontruzant (14)||Samsung Bioepis||trastuzumab||Herceptin||2017|
|Parathyroid Hormone Fragment|
(1) Three additional biosimilars were approved by the EMA but subsequently had their authorizations withdrawn.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.
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.