Marketing approval for US biosimilars has taken off in 2017.  FDA has approved five biosimilar products this year, increasing the number of approved biosimilars from four to nine.  In addition to new biosimilars of AbbVie’s Humira and Janssen’s Remicade, FDA has approved the first two biosimilars for the treatment of cancer.  All five of the products approved this year are biosimilars of complex blockbuster therapeutic antibodies.

Five Biosimilars Approved In the US

FDA has approved five biosimilars in 2017, more than doubling the number of approved biosimilar medicines in the United States.  The biosimilars approved this year include the first two biosimilars approved for cancer treatment, Mylan and Biocon’s Ogivri, a biosimilar of Genentech’s Herceptin, and Amgen and Allergan’s Mvasi, a biosimilar of Genentech’s Avastin. 

The most recently approved biosimilar in the United States is Pfizer’s Ixifi (infliximab-qbtx), the third biosimilar of Remicade approved by FDA.  Ixifi is Pfizer’s second approved Remicade biosimilar; Pfizer also distributes Celltrion and Hospira’s Inflectra (infliximab-dyyb) in the United States.  After the announcement of FDA’s approval of Ixifi, Pfizer reported that it has no current plans to commercialize Ixifi in the United States and is considering its “strategic options.”  The approval of Ixifi follows the April 2016 approval of Inflectra and the April 2017 approval of Samsung Bioepis’s Remicade biosimilar, Renflexis (infliximab-abda).

Also approved this year was Boehringer Ingelheim’s Cyltezo (adalimumab-adbm), a biosimilar of AbbVie’s Humira.  Cyltezo, which received FDA approval in August, is the second Humira biosimilar approved in the United States.  FDA approved Amgen’s Amjevita (adalimumab-atto), the first biosimilar of Humira, in September 2016.

US APPROVED BIOSIMILARS AS OF DECEMBER 2017

Of the nine FDA-approved biosimilars, three are on the US market:  Sandoz’s biosimilar of Neupogen and Pfizer’s and Samsung Bioepis’s biosimilars of Remicade.  As to the other six, the launch dates for two, Mylan/Biocon’s Ogivri and Amgen’s Amjevita, are subject to settlement agreements, Pfizer has no current plans to market Ifixi and the biosimilar makers for the other four products have not launched at risk to date and some are holding off pending resolution of patent litigation.

Pending US Biosimilar Applications

A number of biosimilar applications are currently pending before FDA.  Mylan’s Ogivri, the first U.S. biosimilar of Genentech’s Herceptin (trastuzumab) was approved by FDA on December 1, but at least two other applications for Herceptin biosimilars have been submitted to FDA in recent months.  Amgen and Allergan’s application was submitted for review in July 2017 and Celltrion and Teva’s application for a biosimilar of Herceptin was accepted for review in July 2017.  FDA has also accepted for review two applications for biosimilars of Biogen and Genentech’s Rituxan (rituximab).  FDA accepted Celltrion and Teva’s application for review in June 2017, and Sandoz’s application in September 2017.  Both of these proposed biosimilars have been previously approved by the EMA for marketing in Europe.  FDA is also reviewing Adello Biologics’s proposed biosimilar of Neupogen (filgrastim).  FDA accepted Adello’s application for review in September 2017.  If Adello’s application is approved, it may be the second filgrastim biosimilar approved in the United States, after Sandoz’s Zarxio, the first U.S. biosimilar approved and the first U.S. biosimilar to launch commercially.  FDA accepted Apotex’s application for a proposed Neupogen biosimilar for review in 2015 but the product has not been approved to date. 

Rejected US Biosimilar Applications

Neulasta (pegfilgrastim) biosimilars have faced a number of hurdles in both the United States and Europe, and no biosimilars of Neulasta, a pegylated version of Neupogen, have been approved by FDA or the EMA to date.  In the past six months, FDA rejected two pending pegfilgrastim biosimilar applications.  FDA rejected Coherus’s application in June 2017, although Coherus reports that it hopes to resubmit its application “mid-first quarter of 2018 subject to meeting with FDA.”  Mylan/Biocon’s application for a Neulasta biosimilar was rejected in October 2017.  Biocon has stated that it does not expect the rejection to impact the timing of the commercial launch of its product.  Sandoz reported this year that it intends to resubmit its pegfilgrastim biosimilar application to FDA in 2019.  FDA rejected Sandoz’s application last year.  

The pegfilgrastim applications were not the only biosimilar applications that FDA rejected this year.  In June, FDA rejected for a second time Hospira’s application for a biosimilar of Amgen’s EPO (epoetin alfa). Although a number of biosimilars of EPO have been on the European market for a decade, FDA has not approved an EPO biosimilar for the US market.  Hospira’s biosimilar received a favorable recommendation from the Oncological Drugs Advisory Committee in May 2017 but FDA rejected the application.  Pfizer, Hospira’s parent company, announced that FDA’s rejection related to issues uncovered during a February 2017 FDA inspection of the proposed manufacturing facility for the biosimilar.

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2017 has been a record-setting year for biosimilar approvals in the US with five complex antibody products approved, two of which are in new therapeutic areas for biosimilars.  Biosimilars of pegylated biologic products, such as pegfilgrastim, continue to pose challenges for biosimilar makers.  Biosimilar manufacturers will seek to overcome these challenges, and others, as the biosimilar market develops in the US.