Other Updates

On 21 October 2026, German-headquartered Formycon announced that it has entered into a collaboration with South American company, Biocelys, to develop an undisclosed biosimilar, FYB286.  Formycon refers to the biosimilar as a “niche buster”, a drug for a rare condition with global annual sales in the low- to mid-single-digit billion-dollar range.

The collaboration is aimed at combining Formycon’s experience in biosimilar development with Biocelys’ state-of-the-art manufacturing infrastructure.  Formycon expects demand for FYB286 to increase substantially, particularly in emerging markets, presenting an attractive market opportunity.

Biocelys is indirectly controlled by ATHOS KG, which is Formycon’s largest shareholder.  The project is being financed upfront by Santo Biosimilar GmbH, an affiliated company of ATHOS.  Under the agreement with Santo, Formycon will receive arm’s-length compensation for its development services and will participate in future revenues of Santo with a low double-digit percentage share.  The co-operation agreement between Formycon and Biocelys covers joint development, manufacture, regulatory approval and supply management of FYB286.

On 29 September 2026, the Subject Expert Committee (SEC) under India’s Central Drugs Standard Control Organisation (CDSCO) recommended the approval of Alvotech/Dr Reddy’s Laboratories’ 120 mg/1 mL denosumab, biosimilar to Amgen’s Xgeva®, in a pre-filled syringe (PFS) with an automatic needle guard.  This new presentation expands Alvotech/Dr Reddy’s denosumab portfolio in India, following the approval of its denosumab vial presentation (120 mg/1.7 mL solution for injection) in August 2017.

The approval is conditional on Dr Reddy’s Laboratories submitting an active post-marketing surveillance study protocol for the approved indications within three months and conducting the study in India and adding product label warnings for patients with phenylketonuria regarding the presence of phenylalanine in the product.

Dr Reddy’s and Alvotech entered into a licence and supply agreement in May 2024 for the commercialisation of AVT03 (denosumab), under which Alvotech develops and manufactures the product and Dr Reddy’s commercialises it exclusively in the US, and semi-exclusively in the EU and UK.

Alvotech also has semi-exclusive commercialisation agreements for European markets with STADA (June 2024) in relation to AVT03.  STADA will market AVT03 as Kefdensis® (referencing Amgen’s Prolia®) and Zvogra® (referencing Xgeva®), while Dr. Reddy’s will market AVT03 as Acvybra® (referencing Prolia®) and Xbonzy® (referencing Xgeva®).

On 20 October 2026, Samsung Bioepis announced that, in partnership with Brazilian state-owned pharmaceutical laboratory, Bahiafarma, and Brazilian biotechnology company, Bionovis, it has signed an exclusive partnership agreement to supply SB12, biosimilar to Alexion’s Soliris® (eculizumab), to Brazil’s universal public health system.

The agreement is formed under Brazil’s strategic Productive Development Partnership (PDP) framework.  Under the PDP program, Samsung Bioepis will have exclusive access to Brazil’s public healthcare market to supply eculizumab over a 10-year period form 2027.  During this period, Samsung Bioepis will also transfer technology to its local partners, enabling manufacturing in Brazil.

SB12 was approved in Brazil in December 2024 for the treatment of adults and children with PNH and atypical haemolytic uremic syndrome (aHUS).  It was the second eculizumab biosimilar launched in the US (where it is marketed by Teva as Epysqli®) in April 2025, following the launch of Amgen’s Bkemv® in March 2025.  Epysqli® launched in Germany, Italy and Spain in October 2023 and in Korea in April 2024.

Since 2019, Samsung Bioepis has supplied more than 6 million units of its etanercept and trastuzumab biosimilars in Brazil through the PDP program.  In September 2026, Biocon entered into a supply deal with the Brazilian government to supply Bmab 1500, biosimilar to Roche/Genentech’s Perjeta® (pertuzumab) under the PDP program.

On 18 October 2026, the Economic Times reported that Lupin has received marketing approval from India’s Central Drugs Standard Control Organisation (CDSCO) for its nivolumab biosimilar, referencing BMS’ Opdivo®.  No launch plans have been announced to date.

The biosimilar is approved for the same indications as the reference medicine, with the approval subject to Lupin conducting a Phase IV (post-marketing) study in India.  The approval was granted based on positive results from a local Phase III clinical trial, demonstrating comparable pharmacokinetics, efficacy and immunogenicity of the biosimilar with BMS’ Opdivo®.

Lupin will manufacture the biosimilar in partnership with Virchow Biotech, a contract development and manufacturing organisation (CDMO) headquartered in India.

Zydus’ Tishtha® was the first nivolumab biosimilar to be launched in the world when it became available in India in January 2026 (approved July 2024).  This was followed by the Indian launch of the Dr Reddy’s nivolumab biosimilar Nivorz™ in September 2026.

Amgen is the first known company to file an application with the FDA for a biosimilar to BMS’ Opdivo®, having disclosed the US filing of its aBLA for ABP 206 (nivolumab) on 15 September 2026.  Multiple nivolumab biosimilars are under development including Sandoz’s JPB898, Xbrane/Intas’ Xdivane™, Reliance Life Sciences’ RLS-Nivolumab, Enzene’s candidate, and Boan Biotech’s BA1104.

On 16 October 2026, the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) announced the outcomes of its October 2026 meeting, including positive opinions for two biosimilars and expanded indications for a number of biopharmaceuticals.

Recommended Biosimilars

The CHMP adopted a positive opinion for Accord Healthcare’s biosimilar to Genentech’s Lucentis® (ranibizumab) under the brand name Fovlussea® (10 mg/ml solution for injection).  Accord’s parent company, Intas, received a positive CHMP opinion in April 2026 for another ranibizumab biosimilar brand, Rexatilux®.

Ranibizumab biosimilars already approved and launched in Europe include Samsung Bioepis’ Byooviz® (approved August 2021, commercially available in several European countries since March 2023), STADA/Xbrane’s Ximluci® (launched in the EU in April 2023, following November 2022 approval), Formycon’s Ranivisio® (approved August 2022, being commercialised in the EU by Teva), and Lupin’s Ranluspec® (approved February 2026, commercialised in Europe (excluding Germany) by Sandoz, with planned EU launch in the second half of 2026).  Lupin’s Vislyfa® (ranibizumab) was recommended by the CHMP in May 2026.

The second biosimilar recommended by CHMP in October 2026 is CuraTeQ’s Neuzafy™, biosimilar to Amgen’s Neupogen® (filgrastim).  This is the second biosimilar filgrastim brand for CuraTeQ in Europe, with Zefylti® approved by the European Commission in December 2025.

Recommended Indication Expansions

The CHMP’s October 2026 recommendations for extended indications include:

• Novo Nordisk’s Kyinsu® (insulin icodec, semaglutide) for the treatment of adults with insufficiently controlled type 2 diabetes mellitus as an adjunct to diet and exercise in addition to oral antidiabetic medicinal products;
• AstraZeneca’s pandemic influenza vaccine (H5N1) for active immunisation against influenza in an officially declared pandemic situation; and
• Janssen’s Talvey® (talquetamab) in combination with daratumumab and pomalidomide or in combination with daratumumab, for the treatment of adult patients with relapsed or refractory multiple myeloma, who have received at least one prior therapy.

On 16 October 2026, Genentech and Novartis commenced BPCIA proceedings in the US District Court for the District of Delaware against Amneal Pharmaceuticals and its subsidiary, Kashiv BioSciences, relating to Kashiv’s efforts to bring an omalizumab biosimilar to the US market.

Genentech and Novartis are alleging infringement of 9 US patents relating to antibody manufacturing processes, cell culture media, protein production methods, and the use of anti-IgE antibodies for the treatment of food allergies (12,371,728, 12,371,510, 8,574,869, 11,078,294, 11,987,637, 8,986,957, 9,243,224, 12,030,959 and 12,492,265).

The dispute centres on ADL-018, biosimilar to Genentech/Novartis’ Xolair® (omalizumab), which was developed by Kashiv and licensed to Amneal for exclusive commercialisation in the US.  Amneal announced the submission of its Biologics License Application (BLA) for ADL-018 to the FDA on 26 September 2025, paving the way for regulatory review of the product.

In May 2026, Amneal and Kashiv filed an inter partes review (IPR) petition challenging the validity of US Patent No. 12,030,959, one of the patents in suit in the BPCIA proceedings, which relates to methods of treating food allergies in paediatric patients using omalizumab.  The petition argues that the claimed methods lack novelty and/or are obvious in light of prior clinical trial publications.

Kashiv has entered into agreements for the commercialisation of ADL-018 in other regions, including with CRISTÁLIA for LATAM markets (August 2025), MS Pharma for MENA markets (August 2025) and Alvotech for the EU, UK, Australia, Canada and New Zealand (AVT23, October 2023).  An application for ADL-018 was accepted for review by Health Canada in June 2026 and marketing applications for AVT23 were accepted by the UK’s MHRA in March 2025 and the European Medicines Agency in October 2025.  In September 2026, Alvotech/Advanz Pharma’s Adcomfo® (AVT23/ADL-018) was recommended by the CHMP for approval in 75 mg, 150 mg and 300 mg solution for injection in a pre-filled syringe (PFS) or pre-filled pen (PFP).

Celltrion’s Omlyclo® is currently the only omalizumab biosimilar on the market anywhere in the world.  Omlyclo® was launched in the US in October 2026 (approved March 2025 (75 mg/0.5ml and 150 mg/ml PFS forms) and December 2025 (300mg formulation)).  Celltrion completed its launch of Omlyclo® (75mg and 150mg) in major European countries, including Germany, Spain, the UK and France, in November 2025 and launched the high dose formulation in Europe in August 2026.  In late November 2025, Celltrion announced that it launched Omlyclo® in Brazil.

Teva’s biosimilar omalizumab applications have been accepted for review in the US and EU (March 2026) and CuraTeQ announced Phase 3 study results for its biosimilar omalizumab, BP11, in April 2026.  Mabpharm claims to have had an omalizumab biosimilar (Aomaishu®) approved for marketing in China in May 2023.

On 15 October 2026, Biocad announced that the Russian Ministry of Health has approved biosimilar ocrelizumab (BCD-281) under the name Ocrelizumab Biocad® for the treatment of adult patients with active relapsing forms of multiple sclerosis and early primary progressive multiple sclerosis.

The registration of Ocrelizumab Biocad® was based on data from a Phase 3 clinical trial in Russia comparing the biosimilar (BCD-281) with the reference product, Roche’s Ocrevus® (ocrelizumab).  The commencement of the Phase 3 trial was announced in November 2025, following a Phase 1 clinical trial confirming the biosimilarity of BCD-281 with Ocrevus® across all comparable parameters.

According to Biocad, it is estimated that approximately 150,000 people live with multiple sclerosis in Russia, with approximately 80,000 of these receiving treatment with disease modifying drugs.  Biocad expects the release of its biosimilar ocrelizumab to reduce the cost of the therapy by 25%.

Other ocrelizumab biosimilars are in clinical trials sponsored by Sandoz (Phase 3 trial underway, estimated primary completion in November 2026), Amgen (Phase 3 underway, estimated primary completion in 2027), Celltrion (Phase 3 IND for CT-P53 partially approved by the EMA in August 2023, currently recruiting with estimated primary completion in February 2027) and R-Pharm (Phase 1 study commenced April 2025, primary completion in 2026, with estimated completion in November 2027).  In January 2026, Samsung Bioepis announced that it had added an ocrelizumab biosimilar to its pipeline and, in July 2026, Teva and Polpharma entered into an exclusive licensing agreement for the commercialisation of Polpharma’s ocrelizumab biosimilar, PB018.

On 14 October 2026, Biocon announced that it has entered a global settlement and licence agreement with Genentech for Pebrilzo® (Bmab 1500), biosimilar to Genentech’s Perjeta® (pertuzumab).  The settlement permits Biocon to launch Pebrilzo® in the EU/UK in Q1/2027, in the US in Q3/2028 and in 2026-2028 in other Rest of World countries (or earlier in certain circumstances).

According to Biocon, the agreed launch dates for Pebrilzo® are the earliest licensed launch dates for a pertuzumab biosimilar.  Shanghai Henlius/Organon settled BPCIA proceedings brought by Roche/Genentech in relation to the pertuzumab biosimilar, Poherdy in January 2026, but no licensed launch dates for Poherdy® have been announced.

The Biocon settlement resolves BPCIA proceedings commenced against Biocon by Roche/Genentech in July 2026 in relation to biosimilar pertuzumab.  Roche and Genentech were alleging that Biocon infringes 28 US patents for inventions related to pertuzumab and various manufacturing methods for antibody production, covering pertuzumab as well as its use and manufacture.  The settlement also resolves an ITC complaint filed by Genentech in February 2026 against Biocon’s importation of Bmab 1500 into the US.

Biocon has submitted an abbreviated Biologics License Application (aBLA) to the FDA for approval of Pebrilzo®, the date of filing of which is confidential.  The EMA’s CHMP adopted a positive opinion for Pebrilzo® in September 2026 for the treatment of HER-2 positive breast cancer (420 mg concentrate for solution for infusion).

Shanghai Henlius and Organon had been leading the pertuzumab biosimilar race in major markets, with Poherdy® approvals secured in the US (November 2025), EU (April 2026), and China (as Hanbeiyou®, May 2026).

Approvals for pertuzumab biosimilars have also been granted in India for Intas’ product (December 2024), Zydus’ Sigrima™ (June 2024, subject to ongoing litigation) and Enzene’s Pertuza®/Perzea® (launched September 2025).  In Russia, Biocad’s Pertuvia™ (May 2025, subject to litigation) and R-Pharm’s Persinthia™ (February 2026) are approved.

In June 2026, EirGenix announced that it signed an agreement with an undisclosed company for the licensing and commercialisation of its pertuzumab biosimilar, EG1206A, in Japan.  This followed a 2025 global commercialisation deal with Sandoz for EG1206A, excluding Japan and a number of other countries in Asia.

On 14 October 2026, Alvotech and Advanz Pharma announced they have submitted an application to the European Medicines Agency for AVT29, biosimilar to Regeneron/Bayer’s Eylea® 8 mg (aflibercept), known as Eylea HD™ in the US.  This is the first known regulatory submission anywhere in the world for a high-dose aflibercept biosimilar.

The application was submitted as a line extension to the existing marketing authorisation for Alvotech/Advanz’s Mynzepli®/AVT06 (aflibercept), biosimilar to Regeneron/Bayer’s Eylea®, 2mg.

Alvotech had indicated in March 2026 that it expected to file the first regulatory submission for AVT29 sometime in 2026.  In April 2026, Alvotech commenced a phase 3 clinical trial to evaluate the efficacy and safety of AVT29 compared with Eylea HD® in patients with DME, with an estimated primary completion date of July 2027.

Alvotech and Advanz entered into an agreement in relation to European commercialisation of AVT29 (and AVT06) in June 2024.  Under the agreement, Advanz has exclusive commercialisation rights throughout Europe, except in Germany and France, where it holds semi-exclusive rights.  Teva holds commercialisation rights for AVT29 (and AVT06) in the US.

Amgen is also developing an 8 mg aflibercept biosimilar, ABP 938, and commenced a phase 3 clinical trial in May 2026, with an estimated primary completion date of July 2027.

On 13 October 2026, Formycon and Zydus Lifesciences announced that the FDA has accepted for review their Biologics Licence Application for FYB206, biosimilar to MSD’s Keytruda® (pembrolizumab).  This is the first publicly announced BLA acceptance for a Keytruda® biosimilar in the US.

Zydus had previously expressed optimism that it was well placed to file the first BLA in the US for biosimilar pembrolizumab, following Formycon’s announcement of successful Phase 1 results for FYB206 in February 2026 (the “Dahlia” pharmacokinetic study).  The companies completed clinical development of FYB206 in July 2026 and are relying on a streamlined clinical trial pathway (without a comparative Phase 3 efficacy trial) to accelerate and support the approval of FYB206.

Based on a 12 month FDA review period for the BLA, and a BLA filing date in Q3/2026, a decision on FYB206 is expected in Q3/2027.  A regulatory dossier for FYB206 has also been submitted to Health Canada for approval.

Zydus is commercialising FYB206 in the US and Canada under an exclusive licensing and supply agreement with Formycon entered into in December 2025.  Formycon has entered into separate agreements for commercialisation of FYB206 with MS Pharma for MENA and Lotus for the Asia-Pacific.

Applications for approval of pembrolizumab biosimilars were filed in Korea by Samsung Bioepis (SB27) and Celltrion (CT-P51) in August 2026.  Two months earlier, in June 2026, Samsung Bioepis claimed to be the first developer of a pembrolizumab biosimilar to announce global phase 3 trial results.  Amgen also confirmed on 15 September 2026 that its Keytruda® biosimilar has successfully completed clinical trials with an FDA submission likely later in 2026.

Pembrolizumab biosimilars have reportedly been launched in Paraguay (by Bioeticos in August 2025) and approved in Vietnam (by Biocad in November 2025) and Jordan (by Sana Pharma in February 2026).  Pembrolizumab biosimilars are also in clinical trials including by mAbxience, Sandoz, Bio-Thera, Shanghai Henlius, BioNTech, Qilu Pharmaceutical and Enzene.