Q3 Numbers Show Biosimilar Momentum for Sandoz, Biogen, Pfizer, and Amgen

Biosimilars are beginning to gain momentum, even in the sluggish US market, evidenced by strong US and global sales reported this month by some of the top biosimilar players.

Sandoz

Sandoz reported that its biopharmaceuticals sales were up 18% globally, with “double-digit growth” in Europe for the company’s adalimumab biosimilar, Hyrimoz; rituximab biosimilar, Rixathon; and etanercept biosimilar, Erlezi.

Sandoz also announced that it is entering into a phase 3 study for GP2411, a proposed biosimilar denosumab, referencing Prolia. The study in patients with osteoporosis is expected to be complete in 2022, with data publications anticipated in 2024 and beyond.

Biogen

Biogen, which together with Samsung BioLogics forms the partnership Samsung Bioepis, reported strong biosimilar sales, largely driven by its adalimumab biosimilar, Imraldi, which is available in the European Union.

Its etanercept biosimilar, Benepali, brought in $115.9 million, its adalimumab biosimilar brought in $49.3 million, and its infliximab biosimilar (sold in Europe as Flixabi, though the product is also sold in the United States by Merck as Renflexis) brought in $18.4 million.

While sales of the etanercept product were down slightly over the second quarter (which saw sales of $120.3 million), both the adalimumab and infliximab sales were up (versus second quarter sales of $47.3 million and $16.8 million, respectively).

Pfizer

Pfizer said that its biosimilar infliximab, Inflectra, saw 8% growth in the United States over 2018, rising from $71 million to $77 million. Worldwide, however, sales of the same product, sold as Remsima in other territories, were down by 7%, falling from $166 million in 2018 to $155 million. The company’s biosimilar epoetin alfa, Retacrit, brought in $64 million worldwide, and $42 million in the United States.

Pfizer also revealed that it will launch its biosimilar rituximab, Ruxience, and its biosimilar trastuzumab, Trazimera, early in the new year, following the December 2019 launch of its biosimilar bevacizumab, Zirabev. If Celltrion and Teva—developers of Truxima—do not launch their product sooner, Ruxience will become the first biosimilar rituximab available in the United States.

Amgen

Finally, Amgen said that, together, its biosimilar adalimumab, Amgevita (which has launched in Europe); its biosimilar trastuzumab, Kanjinti; and its biosimilar bevacizumab, Mvasi, brought in a combined $173 million last quarter, $81 million of which were US sales. Biosimilar sales more than doubled quarter over quarter, driven by the Kanjinti and Mvasi launches in the United States.

Notably, Amgen also saw setbacks for its innovator products after they faced biosimilar competition; Neulasta, Amgen’s innovator pegfilgrastim, saw a 32% year-over-year decline, and a 14% quarter-over-quarter decline, after facing competition from biosimilar pegfilgrastim from Mylan and Biocon’s Fulphila and Coherus BioSciences’ Udenyca. The company’s brand-name epoetin alfa, Epogen, which faces competition from Retacrit, saw a 15% year-over-year decline, driven largely by a lower net selling price.

Amgen also noted that its ABP 798, a proposed rituximab biosimilar, met its primary endpoint in a phase 3 study in non—Hodgkin lymphoma, and the company plans to submit a Biologics License Application for the product in the first quarter of 2020.