Big Molecule Watch
December 30, 2021

Year in Review: Top-Five U.S. Biosimilar Market Developments of 2021

As we ring in the new year, we look back at the top U.S. biosimilar market developments of 2021. Here are our top five:

1. SEMGLEE Launches As First-Ever Interchangeable Biosimilar

In July, the FDA approved Viatris Inc.’s (formerly Mylan Pharmaceuticals Inc.) SEMGLEE (insulin-glargine-yfgn), a biosimilar to LANTUS (insulin glargine). SEMGLEE was the first insulin biosimilar granted interchangeable status, meaning it can be substituted for the LANTUS reference product at the pharmacy without the intervention of the prescriber. This interchangeable designation was based on the FDA’s “rigorous approval standards,” including evidence that showed the reference product and biosimilar are highly similar and have no clinically meaningful differences in terms of safety, purity and potency. In October, Express Scripts announced that it would add SEMGLEE as a preferred therapy on its formulary, estimating cost savings of $20 million in 2022. In November, SEMGLEE launched in the U.S. as the first-ever interchangeable biosimilar.

2. FDA Approves Second Biosimilar Insulin Product, Rezvoglar

In December, the FDA approved Eli Lilly’s Rezvoglar (insulin-glargine-aglr), a biosimilar to LANTUS (insulin glargine). Rezvoglar is indicated to improve glycemic control in adult and pediatric patients with type 1 diabetes mellitus and in adults with type 2 diabetes mellitus. Rezvoglar was the second LANTUS biosimilar insulin product approved in the U.S., following the approval and launch of SEMGLEE.

3. FDA Approves Samsung Bioepis and Biogen’s BYOOVIZ (ranibizumab-nuna), a Biosimilar to LUCENTIS (ranibizumab)

In September, Samsung Bioepis and Biogen announced that the FDA had approved BYOOVIZ (ranibizumab-nuna), a biosimilar to LUCENTIS (ranibizumab), for the treatment of neovascular age-related macular degeneration, macular edema following retinal vein occlusion, and myopic choroidal neovascularization. BYOOVIZ was the first ophthalmology biosimilar approved in the U.S.

4. FDA Approves Seventh HUMIRA Biosimilar, Coherus BioSciences’s YUSIMRY (adalimumab-aqvh)

In December, Coherus BioSciences, Inc. announced that the FDA had approved YUSIMRY (adalimumab-aqvh), a biosimilar to HUMIRA. YUSIMRY is indicated for plaque psoriasis, psoriatic arthritis, rheumatoid arthritis, juvenile idiopathic arthritis, ankylosing spondylitis, Crohn’s disease, and ulcerative colitis. YUSIMRY is the seventh biosimilar of HUMIRA to obtain FDA-approval. As previously reported, none of these biosimilars are yet on the U.S. market, 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.

5. FDA Approves CYLTEZO (adalimumab-adbm), the First Interchangeable Biosimilar to HUMIRA

In October, the FDA granted BI’s adalimumab biosimilar CYLTEZO (adalimumab-adbm) interchangeable status. CYLTEZO is the first biosimilar to HUMIRA granted interchangeable status and the second interchangeable biosimilar product approved by the agency after SEMGLEE received interchangeable approval in July 2021. CYLTEZO is not scheduled to launch until July 1, 2023, pursuant to a settlement agreement with AbbVie.


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