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 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 they have not announced their licensed launch dates.

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 FYB203 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.

On 13 October 2026, Xbrane Biopharma announced that patient enrolment has completed for a clinical trial of Xdivane™, Xbrane’s biosimilar to BMS’ Opdivo® (nivolumab).  The trial is sponsored by Intas, which is jointly developing Xdivane™ with Xbrane under a November 2024 global licensing and co-development agreement.

The streamlined, combined phase 1/3 trial enrolled its first patient in November 2025.  It aims to compare the pharmacokinetics, efficacy, safety and immunogenicity of Xdivane™ versus Opdivo® in 340 patients with resected melanoma.  Xbrane previously reported that the FDA and EMA had both supported the streamlined combined Phase I/3 trial.

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

To date, the only country in which it is reported that nivolumab biosimilars have launched is India, a less regulated market.  The two nivolumab biosimilars launched in India are Zydus’ Tishtha™ (January 2026) and Dr Reddy’s Nivorz® (September 2026).

On 8 October 2026, Lupin obtained approval in Australia for three generic ranibizumab products (biosimilars to Novartis’ Lucentis®) under three different brand names, Simulara®, Solentis® and Zivra™.  Each brand is approved in two different formats: 2.3mg/0.23mL solution for injection vial and 1.65mg/0.165 mL solution for injection pre-filled syringe.

Lupin’s wholly owned Australian subsidiary, Generic Health, recently applied for PBS listing of the three brands, with the applications to be considered at the November 2026 PBAC meeting.  Interestingly, Sandoz is the registered owner of the Simulara® trade mark (suggesting that Sandoz may launch one of these biosimilars) and originator Novartis is the registered owner of the Solentis® trade mark in Australia and in some overseas countries (suggesting that perhaps Novartis will seek to cannibalise its own ranibizumab market with the launch of a biosimilar in Australia).  There is no Australian registered trade mark application for Zivra™.

Prior to Lupin’s approvals, there were two ranibizumab biosimilars approved in Australia: Actor Pharmaceuticals’ Raniviz® in 1.65mg/0.165mL PFS (TGA-approved February 2026), and Samsung Bioepis’ Byooviz® 10 mg/mL solution for injection vial (approved August 2022).  No biosimilar product has been launched to date in Australia.  Actor has applied for PBS listing of its biosimilar ranibizumab, with that PBS application also to be considered at the November 2026 PBAC meeting at the same time as Lupin’s.  Despite its approval in 2022, Samsung Bioepis’ Byooviz® is not yet PBS-listed, and there is no suggestion that any PBS application has been made to date.

On 7 October 2026, Celltrion announced that the FDA has approved an additional indication for its IV formulation of Avtozma® (tocilizumab), biosimilar to Roche/Genentech’s Actemra®, for the treatment of COVID-19 in paediatric patients aged 2 years and older.  This expands the previous US approved indications for Avtozma®, which included COVID-19 in adults.

Both the intravenous and subcutaneous formulations of Avtozma® were first approved in the US in January 2025, with the IV formulation launched in October 2025.  In August 2025, the FDA approved an additional indication for the IV formulation for the treatment of cytokine release syndrome.  In December 2025, Celltrion secured reimbursement coverage for Avtozma® IV in the US, with patient reimbursement available from January 2026.

Biogen/Bio-Thera’s Tofidence®/BAT1806 (tocilizumab-bavi) was the first US approved tocilizumab biosimilar (IV formulation approved September 2023; launched May 2024), followed by Fresenius Kabi’s Tyenne® (tocilizumab-aazg) (March 2024; IV formulation launched April 2024; SC formulation launched July 2024).

Celltrion’s Avtozma® was the first tocilizumab biosimilar to be approved in Korea in December 2024.  In the same month, Avtozma® received a positive recommendation by the EMA’s CHMP and subsequently gained European Commission approval in February 2025.  The biosimilar has also been granted marketing approval in other regions, including as the first tocilizumab biosimilar approved in Australia (May 2025), Japan (September 2022) and New Zealand (December 2025).  On 1 October 2026, Celltrion’s Avtozma® became the first tocilizumab biosimilar to be listed on Australia’s Schedule of Pharmaceutical Benefits, after being recommended for PBS-listing at the November 2025 PBAC meeting.

On 7 October 2026, Halozyme Therapeutics announced that it has won an injunction from the specialised Dutch patent court of The Hague, preventing MSD from manufacturing, selling, importing and stockpiling Keytruda SC™ (pembrolizumab and berahyaluronidase alfa-pmph) in Belgium, Denmark, France, Ireland, Italy, Sweden, Switzerland and the Netherlands.

The Court ordered the injunction based on its finding that Halozyme’s patent, EP 297 622 (EP 622) is valid and infringed by MSD.  EP 622 relates to modified PH20 hyaluronidase polypeptides and compositions, which Halozyme claims allow for rapid subcutaneous administration of therapeutic drugs.

MSD’s subcutaneous pembrolizumab formulation uses Alteogen’s ALT-B4 technology, a recombinant human hyaluronidase enzyme platform (berahyaluronidase alfa) designed to convert intravenous (IV) drugs into subcutaneous formulations.  Under licensing terms with MSD, Alteogen obtains milestone payments and ongoing commercial royalties linked to Keytruda SC™ sales.  However, according to Korea Economic Daily, Alteogen expects little financial impact from the Dutch court ruling, with the outcome estimated to affect only 3% of Keytruda SC™’s global market.

The final injunction granted by the Dutch Court follows a ruling of the District Court of The Hague in July 2026 dismissing Halozyme’s application for a preliminary injunction to prevent MSD from marketing Keytruda SC™ in Denmark and Sweden pending the outcome of the substantive proceedings.

MSD and Halozyme are also in dispute elsewhere over patents to Halozyme’s MDASE™ subcutaneous delivery technology.  In December 2025, the Munich Regional Court granted a preliminary injunction, preventing MSD from distributing and offering for sale in Germany Keytruda SC™, based on a finding of the Court that there was imminent infringement of EP 622.

In April 2024, Halozyme sued MSD in the US, alleging that MSD’s subcutaneous pembrolizumab (Keytruda Qlex®) infringes 15 patents.  As of 7 October 2026, MSD had successfully invalidated claims of 9 of Halozyme’s US patents before the Patent Trial and Appeal Board (PTAB) and had a further 8 petitions pending before PTAB.

MSD’s subcutaneous pembrolizumab was approved in Europe in November 2025.  It has also been approved in the US as Keytruda Qlex™ (September 2025); in Canada (February 2026), Korea (May 2026, launched September 2026) and Australia (July 2026), as Keytruda SC™; and in Japan as Keyject™ (September 2026).

While there are no reports of biosimilar subcutaneous pembrolizumab development to date, there are multiple pembrolizumab (IV) biosimilars approved or in development.  For example, Samsung Bioepis and Celltrion each applied for Korean approval of their pembrolizumab biosimilars in August 2026 (SB27 and CT-P51, respectively).  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 this year.  Formycon announced successful Phase 1 results in February 2026, with its US commercialisation partner, Zydus, expressing optimism that it is well-placed to file the first BLA in the US for biosimilar pembrolizumab.