The pharmaceutical landscape is witnessing significant shifts with new developments in the biosimilar market. These include FDA approvals, formulary changes by major pharmacy benefit managers (PBMs), and positive regulatory opinions in Europe, impacting treatment options and costs for various diseases.
FDA Approves Higher Strength Trastuzumab Biosimilar
The FDA has approved the 420 mg strength of Hercessi (trastuzumab-strf), a biosimilar to Herceptin (trastuzumab), for treating HER2-positive breast and gastric cancers. This follows the earlier approval of the 150 mg strength in April 2024. Accord BioPharma, the US specialty division of Intas Pharmaceuticals, plans to commercially launch this biosimilar in early 2025. Hercessi inactivates the HER2 receptor, slowing cancer cell replication. The FDA's approval was based on studies demonstrating the higher dose's equivalent efficacy, safety, and quality compared to Herceptin. Accord BioPharma intends to introduce additional biosimilars, including pegfilgrastim and ustekinumab, in the near future. Shanghai Henlius Biotech developed Hercessi and granted Accord exclusive rights for the US and Canadian markets.
Humira and Stelara Face Coverage Adjustments
UnitedHealth Group will remove AbbVie’s Humira (reference adalimumab) from some preferred drug lists starting January 1, 2025, in favor of less expensive biosimilars for commercial health plans managed by Optum Rx. This decision aligns with similar moves by Cigna’s Evernorth and CVS’ Caremark, which collectively control approximately 80% of the US prescription drug market. Despite the launch of 10 adalimumab biosimilars since January 2023, AbbVie has maintained a significant market position, although a reduced share is anticipated in 2025. The US market share for adalimumab biosimilars has grown to nearly 20% this year. UnitedHealth will continue to cover Humira until the FDA designates certain biosimilars as interchangeable, expected in 2025.
Evernorth also announced it would 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. This biosimilar, produced by affiliate distributor Quallent Pharmaceuticals, offers over 80% savings compared with Stelara, potentially saving patients around $4,000 annually through Quallent’s co-pay assistance program. This 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 occur amid increased regulatory scrutiny of PBMs regarding 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.
CHMP Positive Opinion for Aflibercept Biosimilar
Samsung Bioepis announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) issued a positive scientific opinion on Opuviz (SB15), a biosimilar candidate referencing Eylea (aflibercept). This positive opinion follows a thorough review of the marketing authorization application submitted earlier this year. 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 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.
According to Samsung Bioepis Regulatory Affairs Vice President Jung Byung-in, the company is delighted to receive a positive opinion for Opuviz, their second ophthalmology biosimilar, following Byooviz, and will continue to expand their product portfolio to offer more treatment options for patients globally.
