US biosimilar approvals are becoming faster and less capital-intensive, but patents remain a binding constraint on market entry. Regulators are asking for less clinical evidence and approvals are more forthcoming. Even after approval, however, the launch date is often determined in district court, at the Patent Trial and Appeal Board (PTAB) or in settlement agreements. Recent events across golimumab, aflibercept, pertuzumab and nivolumab point to this continuing pattern.

Approval is getting faster and less costly

Changes in regulatory frameworks across markets have reduced both the time and the capital needed to reach approval, as we discussed in our earlier post on regulatory changes enabling capital efficiency.

The FDA has accepted the BLA for FYB206, Formycon and Zydus’s pembrolizumab biosimilar. It was developed without a comparative Phase 3 efficacy study, relying instead on analytical and functional comparability and a pharmacokinetic study. Under the FDA’s biosimilar user-fee review timeline, a decision is expected in Q3 2027 (Zydus and Formycon press release). In Europe, Biocon’s pertuzumab biosimilar Pebrilzo became the first monoclonal antibody biosimilar to receive a positive CHMP opinion under the EMA’s tailored clinical approach (BioPharm International).

By early June 2026 the FDA had approved 87 biosimilars (Alira Health), though a number of them, including several aflibercept products, are not yet marketed (Biosimilars Review & Report). While approvals are getting quicker and cheaper, the patent landscape has not become any simpler.

Patents remain a significant constraint on market entry

Even as approval becomes more efficient, patent litigation and settlements continue to shape US entry dates for many products, often well after approval. Golimumab shows two mechanisms at work at once.

Golimumab: an injunction against an approved product

On 30 September 2026 the District of Delaware granted Janssen a preliminary injunction against Accord BioPharma (subsidiary of Indian company Intas) and Bio-Thera. The order bars commercial manufacture, sale or import of their golimumab biosimilar BAT2506 in the US, and requires Janssen to post a $98.8 million bond. Janssen’s BPCIA complaint, filed in March 2026, asserted 17 patents.

Those patents cover the antibody, manufacturing methods including cell-culture processes, and methods of treating ankylosing spondylitis and psoriatic arthritis (Pearce IP). Janssen dropped its method-of-treatment claims from the case in March 2026, so the injunction rests on the remaining patents; the court’s opinion was filed under seal (Big Molecule Watch; Big Molecule Watch). US entry for BAT2506 is deferred until the injunction is lifted or the relevant patents fall.

A parallel route through IPRs

On 9 September 2026 the PTAB instituted four inter partes reviews (IPR2026-00256 to -00259) brought by Accord and Bio-Thera against Janssen’s golimumab method-of-treatment patents. The Board found a reasonable likelihood that the challenged claims are unpatentable (Big Molecule Watch).

Final decisions are due within about a year. Because these method-of-treatment patents are no longer part of the district-court case, a PTAB win would remove one barrier but would not by itself lift the injunction. Accord and Bio-Thera have also appealed the injunction, filing notice on 1 October 2026 (Pearce IP).

Settlements shape entry timing

Where parties settle, the launch date becomes a contractual term rather than a litigation outcome.

In aflibercept, Alvotech and Teva settled with Regeneron in December 2025, permitting US launch of AVT06 in Q4 2026, or earlier in certain circumstances, if FDA-approved (Alvotech filing). Sandoz has a similar date (Fierce Pharma), and Celltrion may launch on 31 December 2026 (Regeneron). In Europe, Formycon and Klinge settled with Regeneron and Bayer in March 2026 under a settlement and licence covering Ahzantive and Baiama, and launched in May 2026 (Formycon). Settlements now set aflibercept entry dates in both the US and Europe.

Pertuzumab shows how entry dates can differ by region. Biocon’s global settlement with Genentech, announced in October 2026, allows it to launch Pebrilzo in the EU and UK from Q1 2027 and in the US from Q3 2028, subject to approval (Biocon). That puts its US entry nearly three years after Henlius’s Poherdy was FDA-approved in November 2025 (Henlius and Organon press release). Poherdy itself is not yet marketed in the US (Biosimilars Review & Report); Genentech’s patent suit against it settled in January 2026 on confidential terms, with no launch date announced (Pearce IP).

A settlement trades the possibility of earlier entry for certainty. Sponsors should weigh that against the cost and duration of litigating to judgment, and against the earlier European revenue a settled timetable can secure.

Nivolumab: checkpoint inhibitor litigation begins

On 8 September 2026 Bristol Myers Squibb and Ono filed a BPCIA complaint in Delaware alleging that Amgen’s proposed nivolumab biosimilar, ABP 206, will infringe seven patents (Big Molecule Watch). It is the first US patent litigation over a biosimilar to a major PD-1 inhibitor.

As the first such case, its outcome will indicate how hard US entry will be for other nivolumab biosimilars and for pembrolizumab biosimilars that face similar patents. The FYB206 filing gives pembrolizumab a visible regulatory timeline, but US launch will also depend on Merck’s patent estate, including separate patents covering Keytruda Qlex, its subcutaneous formulation (BioSpace).

Precedents: adalimumab and ustekinumab

The trend is not new. In adalimumab, AbbVie settled with at least eight biosimilar developers, including Amgen, Samsung Bioepis, Sandoz, Fresenius Kabi, Pfizer, Mylan and Boehringer Ingelheim, all agreeing to hold US launch until 2023 (Healio; GaBI Online; BioPharma Dive). Several of these products were already approved, Amgen’s as early as September 2016, and European launches began in October 2018, more than four years before US entry, a delay we spotlighted in our 2018 year-end round-up (PMLive; RAPS).

In ustekinumab, US biosimilar entry was expected when the Stelara composition patent expired in September 2023, but litigation and settlements with J&J delayed it, as we covered in our earlier post on ustekinumab biosimilars. Amgen’s Wezlana, FDA-approved in October 2023, launched only on 1 January 2025, about 15 months after the patent expiry (Center for Biosimilars). Other settlements set dates later still, such as 21 February 2025 for Alvotech and Teva and 15 April 2025 for Formycon and Fresenius Kabi, roughly 17 to 19 months after expiry (Fierce Pharma; Pharmaceutical Technology).

What has changed is the context: approval is now more efficient, and biosimilar markets are relatively more mature, so each period of patent-driven delay carries a higher opportunity cost.

Implications for developers and investors

1. Sustain focus on patent and litigation risk assessment through portfolio prioritisation and development. Revisit it as the patent estate and case law evolve, including whether to run IPRs alongside district-court proceedings.
2. Factor patent risk into business planning scenarios. Build in the cost of litigation and the impact of possible launch delays in each geography, since EU, UK and US entry dates can differ by years. Faster, cheaper approvals improve programme economics, but a plan that assumes US launch soon after approval is likely to overstate near-term value.

Sathguru Management Consultants (SMC) has deep experience in biosimilars across strategic planning, portfolio prioritisation, licensing and partnerships, commercial strategy and project management. To discuss how patent and launch-timing risks affect your biosimilar programmes, connect with our team at lifesciences@sathguru.com.

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