Generics and biosimilars in oncology: is there a need and an opportunity in Central Asia?
What the evidence says on generic and biosimilar cancer medicines lowering prices, EAEU and Uzbek regulatory routes, and unmet need in Central Asia.
Abstract
This brief reviews the evidence that generic and biosimilar cancer medicines lower prices and widen access, the regulatory routes available in Kazakhstan, Azerbaijan and Uzbekistan, and whether there is verified evidence of price barriers in the region. International evidence consistently shows lower prices after biosimilar or generic entry: WHO reports that trastuzumab biosimilars are generally about 65% cheaper than the originator [2,3]; in the EU, the price per treatment day of the biosimilar-accessible oncology antibody market was 37% lower in 2024 than before biosimilar entry, while volume was 68% higher [6]. Regional evidence of price barriers exists but is limited [16,17]. The need is plausible and partly documented; its size cannot yet be measured from public data.
Background
Biosimilars are biological medicines shown to be highly similar to an already authorised reference biological product; generics are equivalent copies of small-molecule medicines. WHO's 2020 guideline on country pharmaceutical pricing policies strongly recommends promoting quality-assured generic and biosimilar medicines, including enabling early market entry, using multiple policies to lower prices through competition and maximising uptake [4]. In December 2019 WHO prequalified its first biosimilar, a trastuzumab product [3]. The companion review (Article A) found state-financed oncology programmes in Kazakhstan, Azerbaijan and Uzbekistan alongside documented signs of constrained access.
Method
A narrative review was conducted on 14–15 October 2026. It covered WHO publications and the 24th EML (2025), EMA statements and product pages (EPARs), IQVIA's report on biosimilar competition in Europe, consolidated texts of Eurasian Economic Commission (EEC) decisions, Uzbek legislation (lex.uz) and Europe PMC/PubMed searches on biosimilar and generic price competition in oncology. Only information verified in a primary source was used; the patent status of individual molecules and local tender prices were not verified.
Findings: price effects and market landscape
WHO reports that trastuzumab biosimilars are generally about 65% cheaper than the originator and that biosimilars are about 60% cheaper than originator products overall, and links significant reductions in breast cancer and lymphoma treatment costs to EML listing and prequalification of trastuzumab and rituximab biosimilars [2,3]. A systematic review from China (39 RCTs and 10 cohort studies) reported that in 2022 bevacizumab, rituximab and trastuzumab biosimilars were priced at 69–90% of reference-drug costs, with uptake of 54–83% [5]. IQVIA's 2025 European report shows that in 2024 biosimilars accounted for 85% of treatment-day volume relative to their reference products in the EU oncology antibody segment (rituximab, trastuzumab, bevacizumab); the price per treatment day of the biosimilar-accessible market was 37% lower and volume 68% higher than in the year before biosimilar entry, while the price of the whole class, which includes newer patent-protected products, fell by only 10% [6]. The same report lists eight bevacizumab, five rituximab and eight trastuzumab biosimilars sold in Europe in 2024 [6]. Originator companies also take part in this market: Pfizer, for example, holds EU marketing authorisations for biosimilars of trastuzumab (Trazimera, 26 July 2018), bevacizumab (Zirabev, 14 February 2019) and rituximab (Ruxience, 1 April 2020), whose reference products are Herceptin, Avastin and MabThera [15]. For small molecules, Dutch claims data show that after imatinib lost exclusivity in 2017, per-patient reimbursement fell by 89% and total imatinib spending by 95% by 2022, while prices of competing on-patent TKIs did not converge [7].
Findings: interchangeability and essential-medicine status — In a joint statement (EMA/627319/2022) the EMA and the Heads of Medicines Agencies (HMA) stated that biosimilars approved in the EU are interchangeable with their reference product or with another biosimilar of the same reference, while decisions on switching and pharmacy-level substitution remain with member states [8]. In 2021 WHO recommended that quality-assured biosimilars of listed biologics be viewed as interchangeable and eligible for selection and procurement at country level [2]. The 24th EML (2025) carries the annotation 'including quality-assured biosimilars' for rituximab, trastuzumab, filgrastim, pegfilgrastim, pembrolizumab (with atezolizumab, cemiplimab and nivolumab as therapeutic alternatives for specific indications), blinatumomab and asparaginase; it recommends country-level selection of quality-assured generics and biosimilars, and lists imatinib, dasatinib and nilotinib as small-molecule targeted therapies [1].
Findings: regulatory routes
In Kazakhstan, an EAEU member, medicines are registered under the Rules approved by EEC Council Decision No. 78 of 3 November 2016; its section on biosimilar dossiers requires comparative studies against a single reference biological product, conducted under the EAEU rules for studies of biological medicines approved by EEC Council Decision No. 89 of the same date, which contain a dedicated chapter on similar biological medicinal products [9,10]. Expert evaluation is performed by the National Center for Expertise of Medicines and Medical Devices (NCELS), which reported that since 30 June 2021 new registration applications are accepted only under EAEU procedures [11]. Uzbekistan has been an EAEU observer state since 11 December 2020, a status without decision-making rights [12]; under Presidential Decree UP-137 of 19 August 2025, from 1 October 2025 medicines registered by WHO-Listed Authorities or by regulators at maturity level 4 of the WHO Global Benchmarking Tool are registered in Uzbekistan by recognition, and WHO-prequalified medicines registered this way are exempt from the national GMP certificate requirement [13]. Azerbaijan, which is outside the EAEU framework, applies its own national registration procedure. On patents, Kazakhstan and Azerbaijan are parties to the Eurasian Patent Convention while Uzbekistan is not, so the patent status of each molecule has to be checked in both national and Eurasian registers [14]; the patent status of individual molecules was not verified in this review.
Findings: unmet need and price barriers in the region — GLOBOCAN 2024 estimates 10,941 new breast cancer cases in the three countries in 2024 (Kazakhstan 4,489; Azerbaijan 1,659; Uzbekistan 4,793), as well as 2,577 leukaemia and 1,612 non-Hodgkin lymphoma cases; these are disease groups in which EML medicines with generic or biosimilar versions are used, although each medicine is indicated only for a subset of patients [19]. In Kazakhstan, 24% of novel cancer medicines registered in 2013–2023 reached full reimbursement, after an average of 35.4 months [17]. In Uzbekistan, outpatient prices of hormonal cancer therapies were 231% above those in Azerbaijan and consumption was 91% lower [16]. Globally, the risk of catastrophic expenditure for priority cancer medicines is concentrated in lower-income settings [18]. No verified study directly compares originator and biosimilar oncology prices in Kazakhstan, Azerbaijan or Uzbekistan.
Discussion
Is there a need? The evidence supports a qualified yes. Internationally, generic and biosimilar entry has repeatedly been followed by lower prices and higher use of the same molecules [2,5,6,7], and WHO explicitly recommends policies that enable it [4]. In the region, the documented signals (slow and partial reimbursement of new cancer medicines in Kazakhstan, high prices and low use of some cancer medicines in Uzbekistan, and out-of-pocket exposure outside state programmes in Azerbaijan) are consistent with affordability constraints that lower-priced equivalents could ease, at least for off-patent molecules such as imatinib, trastuzumab, rituximab and bevacizumab. The size of savings, however, varies widely (from 10–31% discounts in China to deeper reductions in Europe) and depends on procurement design; it does not extend to patent-protected medicines, which is why the EU class-wide price fell by only 10% [5,6]. Part of the documented regional gap concerns novel, patented medicines that generics and biosimilars cannot address [17].
Limitations
Price-effect evidence comes from Europe and China and may not transfer directly to Central Asian procurement systems. IQVIA data are commercial and aggregated. Regional evidence is limited to one conference abstract and one community-pharmacy study covering hormonal therapies [16,17]. Patent expiry dates, local registration status and tender prices of specific molecules in the three countries were not verified, and no medicine-level originator-versus-biosimilar price comparison for the region was found.
Conclusion
Verified international evidence shows that quality-assured generics and biosimilars lower prices and that EU regulators and WHO regard biosimilars as interchangeable; Kazakhstan (EAEU procedures) and Uzbekistan (recognition of WHO-listed and maturity level 4 authorities) offer defined regulatory routes. Unmet need in the region is real but incompletely documented, and medicine-level price monitoring would be needed to quantify the opportunity. At CSC, we follow the needs of institutions in the region for cost-effective, GDP-compliant supply.
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