Tony Hagen is senior managing editor for The Center for Biosimilars®.
The first 3 months of 2019 saw a trio of biosimilar launches on the US market, ahead of the year-ago quarter's pace, and this came despite the disruption caused by coronavirus disease 2019.
The first quarter of 2020 saw 3 biosimilars brought to market in the United States, 2 of them from Pfizer, and no new approvals from the FDA. That compares with 1 launch and 2 approvals in the year-ago quarter.
The year began with robust stock market performance and a much-touted partnership between the FDA and the Federal Trade Commission to clamp down on anticompetitive practices by pharmaceutical companies looking to block biosimilar competition. But the unforeseen happened in the form of the coronavirus disease 2019 (COVID-19) pandemic, which has significantly shifted priorities at the FDA and caused some developers of biosimilars to also shift their efforts toward developing treatments for COVID-19.
The COVID-19 Effect on Launch Patterns
Experts have said launch horizons for approved biosimilars can be expected to be pushed back 6 months or more, based on the complications presented by COVID-19 and the difficulties of marketing products in an environment where sales representatives cannot meet face-to-face with providers and other key individuals.
Among the biosimilars brought to market in the first quarter of this year was Pfizer’s version of rituximab, Ruxience, in January. Ruxience is indicated for the treatment of non-Hodgkin lymphoma, chronic lymphocytic leukemia, granulomatosis with polyangiitis, and microscopic polyangiitis. The product received its FDA approval in July of 2019. Pfizer said in a statement that despite the pandemic, commercialization of the product has moved forward with a combination of field sales rep activity and other forms of promotion.
Pfizer also launched a trastuzumab biosimilar, Trazimera, in February of this year. The agent is indicated for the treatment of HER2-overexpressing breast cancer, in the adjuvant and metastatic settings, and HER2-overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma. The biosimilar was initially approved on March 11, 2019, a full year after its approval.
That product was quickly followed to market by another trastuzumab biosimilar, Herzuma, which was the result of a partnership between Celltrion and Teva. FDA approval for the agent was granted in December of 2018, and Herzuma made it to market in March of this year, roughly 14 months later. Herzuma is indicated for the treatment of patients with HER2-overexpressing breast cancer in both the adjuvant and metastatic settings.
There are currently 5 trastuzumab biosimilars that have FDA approval, and all 5 are on the market, as of April 15, 2020, when Merck launched its Ontruzant trastuzumab biosimilar.
The fifth, Ontruzant, by Samsung Bioepis, is available in Europe and will be distributed in the United States by Merck. No launch date has been announced.
For all of 2019, there were 7 biosimilar launches in the United States and 10 FDA biosimilar approvals.
Sales of Biologics Advance
The promise of biological agents in the United States is illustrated by the tremendous share they command among all medicinal agents in the marketplace. Biologics currently represent 42% of medicine sales, up from 30% in 2014, according to a March 2020 report by IQVIA. The respective dollar totals for biologics are $85.5 billion versus $144.5 billion.
The appeal of launching biosimilars is in the potential earnings. Biogen and Genentech have reaped a windfall of $51 billion from their rituximab originator product, from launch to September 2019, according to IQVIA.
IQVIA estimated that 50% of biologics market sales could face biosimilar competition if all approved biosimilars in the United States were actually launched.