- Big pharma companies are reporting double-digit growth for their biosimilar products, a sign that the U.S. market, while trailing Europe's, is beginning to accelerate.
- Roche's cancer biologics are under the most pressure, with Amgen reporting 15% and 17% market share for its Herceptin and Avastin copycats. Pfizer just launched Rituxan and Avastin biosimilars and is preparing to release a version of Herceptin in February.
- Pfizer, meanwhile, said global biosimilar sales surpassed $900 million in 2019. The pharma expects biosimilars to be a "significant growth contributor to the oncology portfolio not just from a growth percentage perspective but also from a revenue-based perspective."
Biosimilars are a relatively new business in the U.S., having only been enabled by a law passed 10 years ago. The early days were fraught with accusations that originator companies were maneuvering behind the scenes to cut deals and keep biosimilars out — Pfizer sued Johnson & Johnson citing those charges regarding its rheumatoid arthritis drug Remicade (infliximab).
Year-end 2019 earnings from two of the big U.S.-based biosimilar makers suggest that the tide is slowly turning, and could be a sign of things to come for companies like AbbVie that will see big products lose U.S. market exclusivity in coming years.
Amgen said U.S. sales of its Herceptin (trastuzumab) copycat, Kanjinti, which launched at a 15% discount in July 2019, rose from $39 million in the third quarter to $79 million in the fourth quarter. Mvasi (bevacizumab-awwb), which competes with Roche's Avastin (bevacizumab), rose from $42 million to $79 million in the U.S. over the same two quarters, following its July launch at a 15% discount.
Amgen's competitor to AbbVie's $20 billion-a-year Humira, called Amjevita (adalimumab), had sales of $71 million in the fourth quarter and $215 million for all of 2019, but all of those were from international markets as AbbVie's patent protection in the U.S. won't lapse until 2023.
Still, AbbVie has been feeling the pressure from international biosimilar entries, as Humira sales were already showing declines in early 2019.
With the sales growth seen so far and the likely addition of a Remicade biosimilar, Bernstein analyst Ronny Gal said "it's tough to see " Amgen 2020 biosimilar sales of less than $1.8 billion, up from $570 million in 2019. That would be in spite of Pfizer's entry into the competition for U.S. Avastin and Herceptin patients.
For the full year, Pfizer's Retacrit, which competes with Amgen's Epogen (epoetin alfa), sold $141 million in the U.S. and $225 million worldwide, while Remicade biosimilar Inflectra sold $300 million in the U.S. and $625 million globally.
Pfizer did not report sales for Nivestym, a biosimilar to Amgen's Neupogen (filgrastim).