The market and frameworks for biologics and their biosimilars are growing and ever-evolving, as illustrated by the news around rheumatoid arthritis therapies. Isabel Murphy looks at their development, regulation and integration into clinical practice alongside generic chemical drugs.
Hailed by its manufacturer as a first for a key segment of the biologic market, the drug Gobivaz received marketing authorisation from the European Commission in November 2025, following European Medicines Agency (EMA) advice and evaluation.
Icelandic biotech Alvotech produced Gobivaz as a biosimilar to the biologic golimumab (sold under the brand name Simponi). These predominantly treat rheumatoid arthritis (RA), the condition in which autoreactive T cells attack antigens in synovial joints. This causes swelling, stiffness, pain and damage to surrounding bone, tendons, ligaments and tissue, hence the need for active anti-inflammatory substances such as tumour necrosis factor-alpha (TNF-α) inhibitors in anti-arthritic therapeutics.
Given Simponi’s European patents and protections expired only in 2024, Alvotech can claim first place with Gobivaz’s rapid approval as a biosimilar. However, BAT2506, a golimumab biosimilar that uses Simponi as its reference product, was developed by Bio- Thera and STADA Arzneimittel. It also saw marketing authorisation application acceptance in early 2025. Although BAT2506 still awaits full approval, it demonstrates the degree of competitiveness in the biosimilar market.
Equally, other RA biologics exist, notably adalimumab, the active substance marketed under brand names such as Humira. Furthermore, Humira, which achieved FDA approval in 2002, has been competing in Europe with several adalimumab biosimilars since 2017. Globally, there are more than 30 recorded.
The key difference is patent expiry: Simponi’s key patents in Europe expired in 2024, Humira’s several years earlier.
Sarah Macleod, head of global communications at Alvotech, acknowledged: “Each biologic follows its own patent and exclusivity timeline, which means golimumab biosimilars naturally entered development and review later than biosimilars to other TNF-α inhibitors” (such as adalimumab). Gobivaz is launching immediately following the expiry of Simponi’s protections and is the first golimumab biosimilar to reach approval anywhere in the world. Its arrival broadens treatment choice for clinicians and patients by offering an alternative option across both subcutaneous and intravenous use,” said Macleod.
Evidently, golimumab was not the first RA biologic but it (and its newly-approved biosimilar) occupies a specialised market niche, expanding therapeutic and administration options for clinicians and patients alike.
Post-patent landscape
Since the earliest days of drug patenting, the drive towards approval of alternatives has been extremely competitive. The end of exclusivity has sparked innovation, competition and inevitably price pressure.
For traditional chemically synthesised drugs, that competition has long been expressed through generics, but biologics cannot be copied in the same way. The post-patent trajectory for biologics is therefore different and shaped by biosimilars.
Biologics are derived from organic material such as genes and proteins and thus they are defined as much by their manufacturing process as by molecular structure. Challenges including minor differences in cell lines, growth conditions or purification steps subtly alter final biologic products. Identical follow-up versions of biologic drugs after patent expiry cannot be reproduced. Hence regulatory bodies including the EMA require manufacturers to produce drugs with a high degree of similarity to a reference product instead: namely, biosimilars.
Since the earliest days of drug patenting, the drive towards approval of alternatives has been extremely competitive. The end of exclusivity has sparked innovation, competition and inevitably price pressure
The biosimilar regulatory approach begins with the developer submitting a full dossier to the EMA and generally relies more on detailed analytical and functional comparability than on large-scale clinical trials.
Said Macleod: “The goal is to show that the proposed biosimilar is similar to the reference product and any observed difference(s) are not clinically meaningful.”
Based on golimumab and Gobivaz, she outlined the EMA similarity assessment that unfolds when a new biosimilar arises.
Namely EMA requires the results of the following evaluation:
- Detailed analytical comparison of structure, purity and biological activity using state-of-theart methods.
- Functional assays relevant to TNF-α inhibition.
- Pharmacokinetic comparison in humans.
- A confirmatory comparative clinical study in a patient population where differences would be detectable, which for golimumab is rheumatoid arthritis.
For Gobivaz, the confirmatory clinical study was a randomised, double-blind equivalence trial using 102 moderate-to-severe RA patients on methotrexate.
Macleod explained: “The [confirmatory clinical study’s] primary endpoint was the change from baseline in DAS28-CRP, a composite score that measures disease activity based on tender and swollen joints. The study showed therapeutic equivalence between AVT05 and Simponi and no clinically meaningful differences in safety were observed through week 24.
The key difference is patent expiry: Simponi’s key patents in Europe expired in 2024, Humira’s several years earlier
Gobivaz achieved a DAS28-CRP score of 2.9 compared to 3.0 for Simponi; this similarity allowed progression to the next step in the regulatory pathway. Which is where the EMA’s Committee for Medicinal Products for Human Use (CHMP) enters.
“The CHMP reviews the dossier, asks written questions where needed and ultimately adopts a scientific opinion. That opinion is recommended to the European Commission, which issues the legally binding marketing authorisation. The process typically takes around one year from submission to decision,” said Macleod.
While this makes biosimilar development complex and costly, it offers scope for improved access (which Alvotech strives for), increased competition and price reduction after exclusivity ends. Given the nature of biosimilars, the year-long duration of this approach is much shorter than that of generic chemical drugs because much drug efficacy and safety data are already known.
Post-approval landscape
Adoption of biosimilars onto the market is one hurdle but integrating them into the health system is another. Biosimilar rollout is typically managed by healthcare systems’ established national switching frameworks, clear communication with patients, heavy clinician involvement, routine pharmacovigilance and real-world evidence. In 2018 when NHS England’s national programme for adalimumab biosimilars led to uptake levels “approaching 80% within the first few months of launch”, stated Macleod.
Now Alvotech’s commercial partner, Advanz Pharma, has won the NHS tender for golimumab, said Macleod, “which means prescribers will be asked to use the biosimilar in line with national procurement policy”. This enables entire patient cohorts to transition in a controlled and consistent manner. The EU’s stance “remains that authorised biosimilars are interchangeable with their reference medicine”, Macleod added, and thus switching should be seamless.
As with golimumab, when other biologics lose patent protection, it is expected that more biosimilars will enter the market, each following a unique development and regulatory pathway. Post-approval, biosimilars are met with challenges regarding manufacturing, regulation and acceptance.
“Manufacturing monoclonal antibody biosimilars require large-scale, high precision capacity and extensive quality controls. Regulatory expectations are harmonised across Europe, but individual markets differ in procurement models and in how switching policies are implemented,” cautioned Macleod.
“Market acceptance can depend on clinician familiarity with biosimilars, national guidance and the pace at which tenders are awarded. However, biosimilars for TNF-alpha inhibitors are now widely used and well accepted across Europe.”
Post-marketing surveillance continues in order to monitor adverse events and immunogenicity, complemented by real-world evidence. Such surveillance spans several years with safety update reports carried out periodically. Fortunately, biosimilars such as Gobivaz benefit from extensive safety data from their reference products, reinforcing confidence in long-term use.
Gobivaz’s approval illustrates the evolving biosimilar framework: complex to develop, rigorously tested and increasing importance for improving patient access while mitigating healthcare costs.
Its emergence exemplifies an ongoing effort between developers, regulators and healthcare systems to harmonise innovation, competition and safety. This dynamic will likely shape the next generation of biologic therapies for RA and beyond.
Isabel Murphy is a Life Sciences Ambassador and in her final year studying biomedical science at the University of Warwick
