Here are our picks for the top-five most significant U.S. biosimilar market developments in 2018:
1. 2018 Sets New Records for Biosimilar Approvals and Launches
When 2018 began, nine biosimilars had received FDA approval, and only three were on the U.S. market. This past year saw a record-breaking seven FDA approvals of biosimilar products, including many firsts: the first epoetin alfa biosimilar (Pfizer’s Retacrit®), the first and second pegfilgrastim biosimilars (Mylan’s Fulphila® and Coherus’ Udenyca™), and the first rituximab biosimilar (Celltrion and Teva’s Truxima™). 2018 also brought FDA approvals of a second filgrastim biosimilar (Pfizer’s Nivestym®), a third adalimumab biosimilar (Sandoz’s Hyrimoz™), and a second trastuzumab biosimilar (Celltrion and Teva’s Herzuma™).
2. Pegfilgrastim Biosimilars Break Through
For years prior to 2018, biosimilar applicants seemed to struggle to gain FDA approval of biosimilars of Neulasta® (pegfilgrastim). Several aBLAs had been pending before the FDA for years, but were consistently met with rejections. For example, Apotex and Sandoz had originally submitted aBLAs for pegfilgrastim biosimilars in 2014 and 2015, respectively, and engaged in patent litigation under the BPCIA regarding their proposed biosimilars for years, but neither has yet obtained approval. In 2017 alone, Coherus and Mylan both announced that the FDA issued complete response letters (CRLs) regarding their respective applications, and Sandoz announced that it was pushing back its target resubmission date to 2019, after having received a CRL in 2016.
We have seen some positive developments for biosimilars to pegfilgrastim in 2018. This past June, the FDA approved Mylan’s Fulphila® (pegfilgrastim-jmdb) and a few months later, in November, approved Coherus’ Udenyca™ (pegfilgrastim-cbqv). Mylan launched its biosimilar in the U.S. this past July, and Coherus is planning to launch its biosimilar next week, on January 3, 2019.
3. Adalimumab Biosimilar Market Shapes Up
One of the top stories in biosimilars last year was the announcement of a settlement of all patent litigation between AbbVie and Amgen regarding Amjevita™, Amgen’s FDA-approved biosimilar of Humira® (adalimumab). The agreement provided Amgen with a license to launch its product in the United States on January 31, 2023, and settled the parties’ litigation under the BPCIA. Many in the industry were left wondering how things would unfold for other adalimumab biosimilar developers, including Boehringer Ingelheim, who was engaged in BPCIA litigation against AbbVie and whose biosimilar was also FDA-approved.
Although Boehringer Ingelheim and AbbVie remain engaged in litigation, 2018 brought several settlement and license agreements between AbbVie and other adalimumab biosimilar developers. What started as a trickle, with AbbVie announcing global license agreements with Samsung Bioepis in April and Mylan in July, ended up as a flood, with AbbVie granting licenses to Fresenius Kabi, Sandoz, Momenta and Pfizer over the course of October and November. Based on the public disclosures, AbbVie has granted U.S. license dates for adalimumab biosimilars as follows:
- Amgen (already FDA-approved): January 31, 2023
- Samsung Bioepis: June 30, 2023
- Mylan: July 31, 2023
- Fresenius Kabi: September 30, 2023
- Sandoz (already FDA-approved): September 30, 2023
- Momenta: November 20, 2023
- Pfizer: November 20, 2023
4. Some Good News for Pfizer’s Epoetin Alfa Biosimilar
Pfizer first submitted its aBLA for an epoetin alfa biosimilar referencing Amgen’s Epogen® and Johnson & Johnson’s Procrit® in January 2015, and its Hospira subsidiary has been engaged in patent litigation under the BPCIA since September of that year. The road has not been easy for Pfizer, which received CRLs regarding its application in 2015 and 2017, and an adverse jury verdict late last year that awarded Amgen $70 million in damages based on Hospira’s manufacture of 14 batches of drug substance between 2013 and 2015. This year, the district court increased the award to over $80 million, after denying Hospira’s post-trial motions for judgment as a matter of law, and tacking on over $10 million in interest.
But 2018 also brought some bright spots for Pfizer’s biosimilar, when the FDA finally approved Retacrit® (epoetin alfa-epbx) in May, and Pfizer launched the biosimilar, the first of its kind, in the U.S. in November. The district court’s judgment is under appeal.
5. Filgrastim Biosimilar Competition Heats Up
The very first biosimilar that FDA approved through the BPCIA pathway was Sandoz’s Zarxio® (filgrastim-sndz), a biosimilar of Neupogen®. Zarxio® was approved in March 2015, and launched in September that same year. In October 2018, the U.S. filgrastim biosimilar market got a little more crowded, when Pfizer launched Nivestym® (filgrastim-aafi), the second biosimilar of its kind.
Although that was not the first time that a second biosimilar of the same reference product has launched in the U.S.—Pfizer and Samsung Bioepis previously launched biosimilars of Remicade® (infliximab) in 2016 and 2017, respectively—biosimilar penetration has been more robust for filgrastim than infliximab so far. Whereas Sandoz’s parent company, Novartis, has reported steady gains in the U.S. filgrastim market since Zarxio® launched, recently announcing that Zarxio® is now the share leader in the U.S. filgrastim market, Johnson & Johnson has been able to maintain much of the market share for Remicade® despite the availability of two biosimilars. (Indeed, Pfizer and others have sued Johnson & Johnson, alleging anti-competitive practices to maintain the Remicade® market in face of biosimilar completion.)