Eye on Pharma: High-Strength Trastuzumab Biosimilar; Originator Coverage Removals; CHMP Aflibercept Opinion

The FDA approved a new strength of a trastuzumab biosimilar; UnitedHealth will remove reference adalimumab from some preferred drug lists in favor of biosimilars and Evernorth will offer an interchangeable ustekinumab biosimilar at no cost to patients; Samsung Bioepis received a positive regulatory opinion for its aflibercept biosimilar.

FDA Approves Higher Strength of Trastuzumab Biosimilar¹

The FDA approved the 420 mg strength of Hercessi (trastuzumab-strf), a biosimilar to Herceptin (trastuzumab), for the treatment of HER2-positive breast and gastric cancers. This follows an earlier approval of the 150 mg strength in April 2024, positioning Accord BioPharma, the US specialty division of Intas Pharmaceuticals, for a US commercial launch of its first biosimilar in early 2025.

Hercessi targets HER2-overexpressing cancers by inactivating the HER2 receptor, slowing cancer cell replication. The FDA’s decision was based on extensive studies showing the new higher dose of Hercessi’s efficacy, safety, and quality were equivalent to Herceptin. This approval marked a significant milestone for Accord’s entry into the US market, with plans to launch additional biosimilars, including pegfilgrastim and ustekinumab, in the near future. Hercessi was developed by Accord’s partner, Shanghai Henlius Biotech, which granted Accord exclusive rights to bring the biosimilar to the US and Canadian markets.

Humira and Stelara Face Coverage Challenges Amid Biosimilar Competition^2,3

UnitedHealth Group announced it will remove AbbVie’s Humira (reference adalimumab) from some of its preferred drug lists starting January 1, 2025, in favor of less expensive biosimilars for commercial health plans managed by its pharmacy benefits unit, Optum Rx. According to a report from Reuters, this makes Optum the last of the 3 largest US pharmacy benefit managers (PBMs) to exclude Humira, following similar moves by Cigna’s Evernorth and CVS’ Caremark. Together, these PBMs control about 80% of the US prescription drug market.

Despite the launch of 10 adalimumab biosimilars since January 2023, AbbVie has maintained a dominant market position, although it anticipates a reduced share in 2025. The US market share for adalimumab biosimilars has grown to nearly 20% this year. UnitedHealth will continue to provide coverage for Humira until the FDA designates certain biosimilars as interchangeable, expected in 2025.

Additionally, Evernorth announced that starting next year it will offer an interchangeable ustekinumab biosimilar to Johnson & Johnson’s Stelara (reference ustekinumab) at $0 out-of-pocket cost for eligible patients through its specialty pharmacy, Accredo. Produced by affiliate distributor Quallent Pharmaceuticals, this biosimilar will offer over 80% savings compared with Stelara, helping patients save around $4,000 annually through Quallent’s co-pay assistance program.

Evernorth’s initiative aims to lower costs for the more than 30,000 Accredo patients currently on Stelara, as well as for health plan sponsors. Humira biosimilars, also available at $0 out-of-pocket cost through Accredo, could save patients around $3,500 annually.

These changes come amid increased regulatory scrutiny of PBMs over their influence on prescription drug pricing. While PBMs claim to reduce costs through competition, the Federal Trade Commission has criticized them for overcharging patients, citing their vertical integration and market power. PBM executives, however, argue that pharmaceutical companies' complex patent strategies are to blame for high drug prices.

EMA’s CHMP Gives Positive Opinion for Aflibercept Candidate⁴

Samsung Bioepis announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has issued a positive scientific opinion on Opuviz (SB15), a biosimilar candidate referencing Eylea (aflibercept). As reported by Korea Biomedical Review, the positive opinion follows a thorough review of the marketing authorization application submitted earlier this year, marking a critical milestone in the approval process by the European Commission. A formal decision on marketing authorization is typically expected within 2 to 3 months of a positive opinion.

Opuviz is designed to treat ophthalmic diseases such as wet age-related macular degeneration and is a biosimilar to Eylea, developed by Regeneron. Eylea works by inhibiting new blood vessel formation through binding to vascular endothelial growth factor. The global market for Eylea reached approximately 12 trillion won ($8.9 billion) in 2023. Biogen, Samsung Bioepis’ partner for the US and European markets, will handle the marketing and distribution of Opuviz in Europe once final approval is granted.

“We are delighted to have received a positive opinion for Opuviz, our second ophthalmology biosimilar, following Byooviz,” said Samsung Bioepis Regulatory Affairs Vice President Jung Byung-in. “We will continue to expand our product portfolio to offer more treatment options for patients globally.”

References

1. Accord BioPharma, Inc. announces U.S. Food & Drug Administration approval of 420mg strength of Hercessi™ (trastuzumab-strf), a biosimilar to Herceptin® (trastuzumab), for the treatment of several forms of HER2-overexpressing cancer. Accord Biopharma. Press release; September 18, 2024. Accessed September 24, 2024. https://www.biospace.com/press-releases/accord-biopharma-inc-announces-u-s-food-drug-administration-approval-of-420mg-strength-of-hercessi-trastuzumab-strf-a-biosimilar-to-herceptin-trastuzumab-for-the-treatment-of-several-forms-of-her2-overexpressing-cancer

2. Wingrove P. UnitedHealth to remove AbbVie's Humira from some US drug reimbursement lists next year. Reuters. September 10, 2024. Accessed September 24, 2024. https://www.reuters.com/business/healthcare-pharmaceuticals/unitedhealth-remove-abbvies-humira-some-us-drug-reimbursement-lists-next-year-2024-09-10/

3. Manalac T. Cigna continues biosimilar push, targets J&J’s Stelara with no out-of-pocket cost. BioSpace. September 6, 2024. Accessed September 24, 2024. https://www.biospace.com/business/cigna-continues-biosimilar-push-targets-j-js-stelara-with-no-out-of-pocket-cost

4. H-S Lee. EMA issues positive view on Samsung Bioepis’ Eylea biosimilar. Korea Biomedical Review. September 23, 2024. Accessed September 24, 2024. https://www.koreabiomed.com/news/articleView.html?idxno=25196