Blog Big Molecule Watch December 31, 2020

Year in Review: Top-Five U.S. Biosimilar Market Developments of 2020

As we ring in the new year, we look back at the top U.S. biosimilar market developments of 2020. Here are some of our highlights, in no particular order:

1. Pfizer Announces Launches and Pricing Information for Three U.S. Biosimilars

In January, Pfizer announced that it has launched three new biosimilars in the United States: ZIRABEV (bevacizumab-bvzr), RUXIENCE (rituximab-pvvr), and TRAZIMERA (trastuzumab-qyyp).  At the same time, Pfizer announced WAC prices for each of the three biosimilar products that represented at least a 22% discount off the WAC price of the reference products.  According to Pfizer, these discounts would mean each of its three new biosimilar products was expected to launch at the lowest WAC price among bevacizumab, rituximab or trastuzumab products currently on the market.  The U.S. Food and Drug Administration (FDA) approved each of these biosimilar products in 2019.

2. FDA Approves First New Biosimilar of 2020

In June, the FDA approved the first new biosimilar of 2020, Pfizer’s NYVEPRIA (pegfilgrastim-apgf), a biosimilar of Amgen’s NEULASTA.  NYVEPRIA was the fourth biosimilar of NEULASTA to receive FDA licensure, following Mylan’s FULPHILA (pegfilgrastim-jmdb), Coherus’s UDENYCA (pegfilgrastim-jmdb), and Sandoz’s ZIEXTENZO (pegfilgrastim-bmez). These previously approved biosimilars were launched on the U.S. market over the course of 2018-2019.  Over all, NYVEPRIA is the twenty-seventh biosimilar approved under the BPCIA regulatory regime, but was the first biosimilar approval since the FDA approved Amgen’s AVSOLA (infliximab-axxq) on December 6, 2019.

3. FDA Approves Mylan’s Biosimilar of HUMIRA (Adalimumab)

In July, the FDA approved Mylan’s aBLA for HULIO (adalimumab-fkjp), a biosimilar of AbbVie’s HUMIRA.  HULIO was the sixth biosimilar of HUMIRA to obtain FDA-approval, following Amgen’s AMJEVITA (adalimumab-atto) in September 2016, Boehringer Ingelheim’s CYLTEZO (adalimumab-adbm) in August 2017, Sandoz’s HYRIMOZ (adalimumab-adaz) in October 2018, Samsung Bioepis’s HADLIMA (adalimumab-bwwd) in July 2019, and Pfizer’s ABRILADA (adalimumab-afzb) in November 2019. None of these biosimilars are yet on the U.S. market, however, as each biosimilar applicant has entered into a license agreement with AbbVie that permits the applicant to begin U.S. marketing only after a specified date in 2023.  The U.S. license dates can be found here.

4. FDA Approves Amgen’s RIABNI (rituximab-arrx), A Biosimilar To Rituxan (rituximab)

In December, Amgen announced that the FDA had approved RIABNI (rituximab-arrx), a biosimilar to Rituxan® (rituximab), for the treatment of adult patients with Non-Hodgkin’s Lymphoma (NHL), Chronic Lymphocytic Leukemia (CLL), Granulomatosis with Polyangiitis (GPA) (Wegener’s Granulomatosis), and Microscopic Polyangiitis (MPA).  Amgen announced that RIABNI will be made available in the U.S. in January 2021.  RIABNI was only the third FDA approval for a biosimilar in 2020, following the approval of Pfizer’s NYVEPRIA in June and Mylan’s HULIO in July.

5. Samsung Bioepis and Merck Launch of Trastuzumab Biosimilar

In April, Samsung Bioepis and Merck announced the U.S. launch of ONTRUZANT (trastuzumab-dttb), a biosimilar to HERCEPTIN (trastuzumab).  According to the press release, Samsung Bioepis is responsible for preclinical and clinical development, manufacturing, and regulatory registration, while Merck is responsible for commercialization.  ONTRUZANT is the fifth HERCEPTIN biosimilar to reach the U.S. market.

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