Biosimilars Boom: 2025’s Fast Track Approvals Look to Reshape Healthcare

Biosimilars are rapidly transforming the U.S. pharmaceutical market amid rising healthcare costs and a shift in interchangeability policy. This has accelerated development timelines and lowered costs, driving a surge in 2025 approvals across immunology, oncology, and endocrinology. Market competition is intensifying, with some biosimilars offering wholesale and ASP discounts, signaling significant cost savings and ultimately broader adoption.

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By Rothwell, Figg, Ernst, and Manbeck, P.C. | Original Article

With healthcare costs rising and biologics driving a large portion of drug spend, the next wave of biosimilar launches promises to reshape the U.S. pharmaceutical market in profound ways, including reduced prices for close analogs of existing reference blockbuster branded products. This post provides a roadmap into this evolution, focusing on potential biosimilar approvals and launches through 2029 in view of a changing regulatory scheme, as well as the cost implications of the changing landscape.

Primer – What are Biosimilars?

Biosimilars are biologic therapeutic products that are highly similar to an already approved (so-called “reference”) biologic, with no clinically meaningful differences with regards to safety, purity, and potency. In the United States, biosimilars are approved under the Public Health Service (PHS) Act via the abbreviated 351(k) Biologics License Application (BLA) pathway. Under this framework, the review standard focuses on a “totality of evidence” model, allowing extrapolation of indications if similarity is established. Importantly, biosimilars may also seek “interchangeable” designation, which (until recently) required additional switching studies to support automatic substitution at the pharmacy level. However, as of June 2024, the FDA issued draft guidance eliminating the need for switching studies, permitting interchangeability designations based on comparative analytical and clinical data alone, aligning the U.S. more closely with European Medicines Agency (EMA) and World Health Organization (WHO) frameworks.

2025 Off to a Fast Start: 12 Biosimilar Approvals and Counting

Within the first half of 2025, the FDA had already approved twelve biosimilars across immunology, oncology, and endocrinology. The approved biosimilars reference Stelara (ustekinumab), Prolia/Xgeva (denosumab), Actemra (tocilizumab), and Xolair (omalizumab), among others.[1]

As of 2025, the following biosimilars have been approved:[2]

What stands out is the pace: these approvals occurred faster than during prior years, suggesting regulators and developers alike are adapting to biosimilar pathways with more confidence and coordination.

A Turning Point in FDA Interchangeability Policy

As noted above, perhaps the most consequential change to the field is regulatory: in June 2024, the FDA issued draft guidance eliminating the requirement for switching studies in order to obtain interchangeability designation.[3] Manufacturers can now rely on comparative analytical and clinical data instead of conducting costly and time-consuming trials.[4] The removal of switching studies is predicted to cut biosimilar development costs from $100-$300 million to $75-250 million and timelines from 7-8 years down to 6.5-7.5 years, with further reductions to $50-75 million and 5-6 years if Phase 3 studies are also eliminated.[5]

This change is already affecting how biosimilar developers approach product development. For example, Formycon,[6] Sandoz,[7] and Bio-Thera[8] all cancelled or modified Phase 3 trials for their Keytruda (pembrolizumab) biosimilars, aiming instead for FDA submission based on Phase 1 data and analytics. This could signal an accelerated path to market for other oncology biosimilars in development and a major reduction in overall biosimilar development costs.

Pipeline Highlights by Therapeutic Class

During the next half-decade, a significant number of biosimilars are expected to enter the market across a myriad of therapeutic classes. Some of the most prominent candidates in development include:

Immunology

• Simponi (golimumab) biosimilars from Bio-Thera (BAT2506)[9] and Alvotech/Teva (AVT05) are progressing, with launches expected in 2025-2027.[10]

• Entyvio (vedolizumab) biosimilars from Polpharma and Alvotech are in Phase 3, with expected launches around 2028-2032, pending IV and SC formulation development.[11]

• Cosentyx (secukinumab) biosimilars are in Phase 3 trials by Celltrion (CT-P55) and Bio-Thera (BAT2306), with exclusivity set to expire in 2029.[12]

  
  

Oncology

• Pembrolizumab (Keytruda) biosimilars are being pursued by at least seven developers, including Samsung Bioepis, Sandoz, Celltrion, Bio-Thera, and Amgen.[13] Launches could begin around 2028-2029, but may accelerate due to the regulatory flexibility described herein.

• Other oncology biosimilars in active development include agents referencing Opdivo (nivolumab), Herceptin (trastuzumab), and Perjeta (pertuzumab).[14]

  
  

Endocrinology & Pulmonology

• A biosimilar for Trulicity (dulaglutide) from Boan Biotech, already approved in China, is in early development, with exclusivity set to expire in late 2027.[15]

• Nucala (mepolizumab) biosimilars are entering early-phase trials, targeting a post-2027 window.[16]

  
  

Ophthalmology

• Ongoing development of additional biosimilars for Eylea (aflibercept) and Lucentis (ranibizumab).[17]

  
  

Cost Implications and Market Forces

In spring 2025, though approximately 73 biosimilars have been approved, only 48 have launched.[18] That means 34% of approvals remain uncommercialized (often due to market barriers such as patent disputes or pricing challenges), a key reminder that FDA approval does not guarantee immediate or near-term market entry. Q1 2025 alone saw 10 new biosimilar approvals, including multiple entrants for Stelara, Prolia/Xgeva, and Actemra, and 7 biosimilar launches, including Wezlana (Amgen), Selarsdi (Alvotech/Teva), and Steqeyma (Celltrion) for Stelara.[19]

Biosimilar competition is driving significant price reductions in 2025. Oncology biosimilars, such as trastuzumab, bevacizumab, and rituximab, show average sales price (ASP) discounts of 50-70%.[20] Denosumab biosimilars launched with wholesale acquisition cost (WAC) discounts exceeding 80% versus Prolia and Xgeva, while tocilizumab biosimilars vary, with Tofidence priced 0.3% below the reference ASP and Tyenne 29% lower.[21] In immunology, infliximab and adalimumab biosimilars offer WAC reductions of 20–60%, with unbranded variants leading the trend. Pegfilgrastim’s ASP dropped 95% since biosimilar entry, and rituximab and trastuzumab fell 33% and 24%, respectively.[22] These trends signal deeper savings as more biosimilars enter pharmacy-benefit areas like endocrinology and ophthalmology.

Bottom Line: A Market About to Tip

Between newly approved agents, relaxed FDA requirements, and a maturing biosimilar developer ecosystem, the U.S. pipeline for 2025-2029 is poised to deliver wider biosimilar adoption, faster launches, and lower prices. Key therapeutic areas to watch include immunology, oncology, and endocrinology, with Cosentyx, Entyvio, Keytruda, and Trulicity representing pivotal inflection points in the next phase of biosimilar growth.

Disclaimer: The information contained in this posting does not, and is not intended to, constitute legal advice or express any opinion to be relied upon legally, for investment purposes or otherwise. If you would like to obtain legal advice relating to the subject matter addressed in this posting, please consult with us or your attorney. The information in this post is also based upon publicly available information, presents opinions, and does not represent in any way whatsoever the opinions or official positions of the entities or individuals referenced herein.

[1] IPD Analytics. “Biosimilar Pipeline 2H 2025.” IPD Analytics, July 2025, www.ipdanalytics.com/sample-reports-1/biosimilar-pipeline-2h-2025.

[2] FDA Biosimilar Product Information – Approved Biosimilar Products. Accessed July 15, 2025, https://www.fda.gov/drugs/biosimilars/biosimilar-product-information.

[3] U.S. Food and Drug Administration. “FDA Updates Guidance on Interchangeability.” FDA.gov, 20 June 2024, www.fda.gov/drugs/drug-safety-and-availability/fda-updates-guidance-interchangeability.

[4] IPD Analytics. “Biosimilar Pipeline 2H 2025.” IPD Analytics, July 2025, www.ipdanalytics.com/sample-reports-1/biosimilar-pipeline-2h-2025.

[5] Id.

[6] Pearce IP. “Formycon to Terminate Ph 3 Trial and Pursue US-Approval of Pembrolizumab Biosimilar Based on Ph 1/Analytical Data.” Pearce IP, 17 Feb. 2025, www.pearceip.law/2025/02/17/formycon-to-terminate-ph-3-trial-and-pursue-us-approval-of-pembrolizumab-biosimilar-based-on-ph-1-analytical-data/.

[7] Pearce IP. “Sandoz to ‘Minimise’ Phase 3 Biosimilar Pembrolizumab Trial Due to Regulatory Streamlining.” Pearce IP, 30 Apr. 2025, www.pearceip.law/2025/04/30/sandoz-to-minimise-phase-3-biosimilar-pembrolizumab-trial-due-to-regulatory-streamlining/.

[8] Bio-Thera Solutions. “Bio-Thera Solutions Initiates Integrated Phase I/Phase III Clinical Trial for BAT3306, a Proposed Biosimilar of Keytruda® (Pembrolizumab).” PR Newswire, 25 July 2024, www.prnewswire.com/news-releases/bio-thera-solutions-initiates-integrated-phase-i–phase-iii-clinical-trial-for-bat3306-a-proposed-biosimilar-of-keytruda-pembrolizumab-302206502.html.

[9] Bio-Thera Solutions. “Bio-Thera Solutions Announces Exclusive Commercialization and License Agreement with Intas Pharmaceuticals for BAT2506, a Proposed Biosimilar Referencing Simponi® (Golimumab), in the United States of America.” Bio-Thera Solutions, 10 Feb. 2025, www.bio-thera.com/plus/view.php?aid=1130.

[10] Alvotech and Teva Pharmaceuticals. “Alvotech and Teva Announce Filing Acceptance of U.S. Biologics License Applications for AVT05, a Proposed Biosimilar to Simponi® and Simponi Aria® (Golimumab).” Alvotech, 27 Jan. 2025, investors.alvotech.com/news-releases/news-release-details/alvotech-and-teva-announce-filing-acceptance-us-biologic/

[11] IPD Analytics. “Biosimilar Pipeline 2H 2025.” IPD Analytics, July 2025, www.ipdanalytics.com/sample-reports-1/biosimilar-pipeline-2h-2025.

[12] Id.

[13] Id.

[14] Id.

[15] Boan Biotech. “Boan’s Dulaglutide Cleared by FDA for Clinical Trials.” Boan Biotech, 5 Aug. 2024, www.boan-bio.com/en/phone/info.php?id=317.

[16] IPD Analytics. “Biosimilar Pipeline 2H 2025.” IPD Analytics, July 2025, www.ipdanalytics.com/sample-reports-1/biosimilar-pipeline-2h-2025.

[17] Id.; Biosimilars for both products are already on the market.

[18] BiologicsHQ. “SB Biosimilar Market Report Q2 2025.” BiologicsHQ, Apr. 2025, biologicshq.com/wp-content/uploads/2025/04/SB-Biosimilar-Market-Report-Q2-2025.pdf.

[19] Id.

[20] Id.

[21] Id.

[22] IPD Analytics. “Biosimilar Pipeline 2H 2025.” IPD Analytics, July 2025, www.ipdanalytics.com/sample-reports-1/biosimilar-pipeline-2h-2025.