On 10 August 2026, Samsung Bioepis announced that it has applied to Korea’s Ministry of Food and Drug Safety for approval of SB27, biosimilar to MSD’s Keytruda® (pembrolizumab).  According to Samsung Bioepis, this application puts it ahead of competitor pembrolizumab biosimilars in the Korean product approval process.

Samsung Bioepis announced positive results from global phase 1 and 3 clinical trials for SB27 on 29 June 2026, confirming its equivalence with Keytruda®.  At the time, Samsung Bioepis said it was the first developer of a pembrolizumab biosimilar to announce global phase 3 trial results.  The phase 1 and phase 3 trials were commenced in 2024, in an “overlap strategy” designed to accelerate SB27 development, with the studies expected to be completed by the end of 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).

There are multiple pembrolizumab biosimilars in development.  Formycon’s FYB206 demonstrated pharmacokinetic bioequivalence with Keytruda® in the Phase 1 “Dahlia” study (reported in February 2026).  Formycon’s US commercialisation partner, Zydus, has previously expressed optimism that it is well-placed to file the first BLA in the US for biosimilar pembrolizumab.  Formycon has also announced agreements for commercialisation of pembrolizumab biosimilar FYB206 with MS Pharma for the MENA region and Lotus for the Asia-Pacific.

Other companies with pembrolizumab biosimilars in clinical trials include Amgen, mAbxience, Sandoz, Shanghai Henlius, BioNTech, Qilu Pharmaceutical and Enzene.  Alvotech and Dr Reddy’s have entered into a global collaboration and licence agreement to co-develop, manufacture and commercialise a Keytruda® biosimilar and Bio-Thera and Avalon are partnering on commercialisation of a pembrolizumab biosimilar (BAT3306) in Saudi Arabia/MENA.

On 10 August 2026, Samsung Bioepis announced the European launch of Opuviz®/SB15 (aflibercept), biosimilar to Regeneron/Bayer’s Eylea® 2mg in a pre-filled syringe (PFS) presentation (40 mg/mL).  Opuviz® was the third aflibercept biosimilar to be approved in the EU in November 2024 and was launched in Europe in a vial form in May 2026.

The original launch of Opuviz® followed a settlement agreement between Samsung Bioepis and Regeneron/Bayer announced in January 2026 under which Samsung Bioepis was permitted to launch SB15 in the UK from January 2026, in Europe from April 2026 and in other countries covered by the agreement from May 2026 (excluding Korea where it had already been on the market as Afilivu® since 2024).  Samsung Bioepis has a separate settlement agreement with Regeneron/Bayer for North America, permitting launch of SB15 in the US from January 2027.

Opuviz™ was the third aflibercept biosimilar to be approved in the EU (in November 2024) and has been approved elsewhere, including the UK (April 2025), the US (May 2024), Korea (as Afilivu®) (February 2024) and Australia (September 2025).

Other aflibercept biosimilars launched in UK/Europe, including in PFS form, include Sandoz’s Afqlir® (UK launch in November 2025), Celltrion’s Eydenzelt® (UK/EU launch in December 2025), Biocon’s Yesafili® (UK launch in January 2026), Alvotech’s Mynzepli® (UK launch January 2026) and Formycon/Klinge’s Ahzantive®/Baiama® (EU launch in May 2026).

On 6 August 2026, Replimune announced that its vusolimogene oderparepvec-wtpg, formerly known as RP1 but newly branded as Tudriqev™, has received accelerated approval from the FDA for the treatment of adults with unresectable advanced cutaneous melanoma who experienced disease progression on an anti-PD-1 antibody-based regimen.

Tudriqev™ is a is a genetically modified herpes simplex virus, type 1 (HSV-1) oncolytic viral therapy that is administered via direct intra-tumour injection into superficial and deep and/or visceral lesions.

The FDA approval comes despite the FDA’s 30 July 2026 briefing document for Replimune’s third submission of the Biologics License Application (BLA) for RP1 in combination with BMS’ Opdivo® (nivolumab) for the treatment of advanced melanoma.

The FDA’s briefing document stated in relation to Replimune’s IGNYTE study:

• The study’s “criteria for response assessment confounds interpretation of the reported efficacy results and limits FDA’s ability to verify the reported results”;
• “The objective response data from the single-arm IGNYTE study are not of sufficient magnitude to overcome concerns about the contribution of effect, particularly in the absence of a reliable historical control, and therefore it cannot be determined whether RP1 contributes to any observed effect when administered in combination with nivolumab”; and
• “The overall survival analysis from the single-arm IGNYTE study is not interpretable”.

According to Replimune, continued approval of Tudriqev™ may be contingent on verification of its clinical benefit in confirmatory trials.  A confirmatory Phase 3 trial, IGNYTE-3, is ongoing and assessing Tudriqev™ in combination with nivolumab (NCT06264180).

On 5 August 2026, Novo Nordisk announced that The Hague District Court granted a preliminary injunction (PI) preventing Ceban Ziekenhuisfarmacie B.V. (a retail pharmacy based in the Netherlands) from selling a compounded semaglutide nasal spray under the name Semanova.  To date, no nasal spray formulations of semaglutide have been given regulatory approval anywhere in the world.

Novo Nordisk’s European compound patent for semaglutide (EP 1 863 839) expired in March 2026.  In the Netherlands, Novo Nordisk holds a supplementary protection certificate (SPC) extending patent protection over semaglutide until 19 March 2031.

The court found that Ceban’s nasal spray infringed Novo Nordisk’s Dutch SPC for semaglutide.  As a result, the court has ordered Ceban to cease the infringing activities, remove product listings, disclose commercial supply chain information and reimburse Novo Nordisk’s legal costs.

According to JUVE Patent, Ceban’s defence relied on the pharmacy compounding exemption under Article 54c(e) of the Dutch Patent Act, which permits small-scale compounding for individual patients pursuant to a medical prescription.  The court found that Ceban’s resale of nasal sprays to other pharmacies and registration in the Dutch drug database fell outside of this exemption.

In Europe, Novo Nordisk markets semaglutide as Wegovy® for weight loss (subcutaneous injectable (0.25 mg, 0.5 mg, 1 mg, 1.7 mg or 2.4 mg standard dose or 7.2 mg high dose) or oral pill), and as Ozempic® (once-weekly subcutaneous injectable) and Rybelsus® (once-daily oral pill) for the treatment of type 2 diabetes.

Generic semaglutide products are yet to launch in Europe but have launched in India in March 2026 (including by Dr Reddy’s, Zydus, Alkem, Sun Pharma and Glenmark) and Canada in May 2026 (by Apotex and Dr Reddy’s).  Apotex received the first US FDA Tentative Approval for its generic semaglutide ANDA in April 2026, giving it an opportunity to be one of the first to launch generic Ozempic® in the US following expiry of Novo Nordisk’s exclusivity/patents and subject to ongoing US patent infringement litigation.

On 3 August 2026, Ono Pharmaceutical reported that Opdivo® (nivolumab) was approved by South Korea’s Ministry of Food and Drug Safety (MFDS) for neoadjuvant treatment of adult patients with resectable non-small cell lung cancer (NSCLC) and no known epidermal growth factor receptor (EGFR) mutations or anaplastic lymphoma kinase (ALK) rearrangements in combination with platinum-doublet chemotherapy, followed by single-agent as adjuvant treatment after surgery.

Ono retains commercialisation rights for Opdivo® in Japan, South Korea and Taiwan under a 2011 agreement with BMS, while BMS has the rights elsewhere in the world.

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), following the High Court of Delhi’s 12 January 2026 reversal on appeal of a preliminary injunction granted to BMS in relation to the biosimilar.  In July 2026, Biocad’s Nivocad® received marketing approval in Russia.

A number of nivolumab biosimilars are under development including Sandoz’s JPB898, Xbrane/Intas’ Xdivane™, Amgen’s ABP 206, Reliance Life Sciences’ RLS-Nivolumab, Enzene’s candidate, Boan Biotech’s BA1104, NeuClone’s candidate and Shilpa’s intravenous nivolumab biosimilar.  Biosimilar developers are taking advantage of the reduced Phase 3 trial requirements globally, including Sandoz streamlining its biosimilar nivolumab clinical trials.

BMS’ patent rights for nivolumab are being challenged, including in the EU where EP 3 288 980, for a composition comprising nivolumab for use in a method of treating PD-L1-positive melanoma, was revoked in July 2026 following an opposition by 5 “strawperson” opponents.

On 3 August 2026, Biocon announced the US launch of Yesafili™ (aflibercept), biosimilar to Regeneron’s Eylea® 2 mg.

Yesafili™ was one of the first approved interchangeable aflibercept (2 mg) biosimilars in the US in May 2024.  Biocon and Regeneron settled US BPCIA litigation regarding aflibercept in April 2025, paving the way for a US launch of Yesafili™ in the second half of 2026.

Yesafili™ is only the second aflibercept biosimilar on the US market, following the launch of Amgen’s Pavblu® in October 2024, after the US Court of Appeals for the Federal Circuit’s denial of Regeneron’s application for an injunction in relation to that biosimilar. The FDA has not designated Pavblu® as interchangeable with Eylea®.

Biocon’s launch of Yesafili™ leads a stream of upcoming aflibercept biosimilar launches in the US resulting from litigation settlements, including Formycon/Klinge’s Ahzantive® (approved June 2024, due to launch Q4/2026), Sandoz’s Enzeevu® (approved August 2024, due to launch Q4/2026), Celltrion’s Eydenzelt® (approved October 2025, due to launch Q4/2026), and Alvotech/Teva’s AVT06 due to launch Q4/2026, subject to regulatory approval).

In January 2026, Biocon reached a settlement and licence agreement with Regeneron and Bayer for Yesafili™ in Europe and ROW, permitting Biocon to commercialise Yesafili™ in Europe/ROW from March 2026, other than in the UK (where it launched in January 2026) and Canada (where it launched in July 2025 as a result of a Canadian settlement).

On 1 August 2026, the Economic Times reported that the FDA has approved Dr Reddy’s biosimilar to Genentech’s Rituxan® (rituximab).  The product will be commercialised in the US by Fresenius Kabi.

The FDA approval follows a Complete Response Letter (CRL) issued to Dr Reddy’s by the FDA in April 2024 regarding its biosimilar rituximab BLA.  The CRL related to the results of regulatory inspections at Dr Reddy’s Biologics facility in 2023, as well as “certain aspects pertaining to the BLA”.  Also in 2024, a settlement was reached in relation to patent infringement claims brought in the US District Court for the District of New Jersey by Genentech, Roche and Biogen against Dr Reddy’s and Fresenius Kabi in respect of Dr Reddy’s rituximab.  The terms of the settlement are confidential.

Dr Reddy’s rituximab biosimilar is already commercialised in more than 28 markets, including India (marketed as Reditux®) and Europe (marketed as Ituxredi®), and has also received marketing approval in Switzerland and Canada.

Rituxan® was first approved in the US on 26 November 1997 and was one of the first mAbs to face biosimilar competition.  There are three rituximab biosimilars currently on the US market: Teva and Celltrion’s Truxima® (launched in May 2020, interchangeability status announced July 2026), Pfizer’s Ruxience® (launched in January 2020) and Amgen and Allergan’s Riabni™ (approved by the FDA in December 2020).

On 31 July 2026, judgment was published in relation to procedural matters in proceedings commenced earlier this year in the High Court of England and Wales (Patents Court) by each of Fresenius Kabi, Advanz Pharma, Accord Healthcare and Samsung Bioepis (Biosimilar Claimants) against Millennium Pharmaceuticals, a Takeda subsidiary.  The Biosimilar Claimants are seeking to clear the way for the UK launch of their biosimilar vedolizumab products, referencing Takeda’s Entyvio®.

In each of the proceedings, the Biosimilar Claimant has applied for the revocation of various Millenium patents and/or for non-infringement declarations or Arrow declarations (that a particular product/process was obvious at the relevant priority date).  The patents at issue concern dosing regimens in respect of vedolizumab (EP (UK) 3329965, 3311834 and pending patent applications EP4378484 and EP4438625)) and formulations for vedolizumab (EP (UK) 2704798 and 4403579).

The four proceedings are being heard together and the Biosimilar Claimants have agreed to use their “best endeavours” to align the grounds of invalidity they are relying on by 10 September 2026.  A trial is currently scheduled for April 2027.

The July 2026 judgment primarily concerned a dispute between Advanz and Millenium/Takeda in relation to the confidentiality regime applying to information about Advanz’s IV and SC vedolizumab formulations.  The parties had agreed that only UK lawyers and two in-house personnel should have access to Advanz’s confidential information and that the in-house individuals should be prohibited from being involved in claim drafting prior to the grant of a patent.  Advanz argued that the restriction on claim drafting should also extend to claim amendments or auxiliary requests in foreign proceedings or the European Patent Office for granted patents.  In his July 2026 judgment, Mr Justice Mellor concluded that the extended prohibition sought by Advanz should be imposed.

Advanz is the UK, EU and Swiss commercialisation partner for Alvotech’s intravenous vedolizumab biosimilar, AVT16, under a 2023 licence agreement.  In June 2026, Alvotech announced that its BLA for AVT16 was the first to be accepted for review by the FDA.  Alvotech also has a subcutaneous vedolizumab biosimilar under development, AVT80.

Fresenius Kabi is commercialising Polpharma Biologics’ PB016 (vedolizumab) in the UK, under a global licensing agreement (excluding MENA region) entered in August 2025.  On the same date on which the July 2026 judgment was published, Polpharma/Fresenius announced that the Marketing Authorisation Application for PB016 had been accepted for review by the European Medicines Agency (with the corresponding BLA accepted by the FDA).

Accord Healthcare’s parent company, Intas, received approval to conduct a Phase 1 bioequivalence study for its vedolizumab biosimilar, INTP53, in February 2025.  Samsung Bioepis’ vedolizumab biosimilar will be commercialised (except in certain Asian countries) by Sandoz under a global licence, development and commercialisation agreement announced in March 2026.

On 31 July 2026, Polpharma Biologics and Fresenius Kabi announced that Polpharma’s Biologics License Application (BLA) and Marketing Authorisation Application (MAA) for PB016 (vedolizumab), biosimilar to Takeda’s Entyvio®, have been accepted for review by the FDA and European Medicines Agency (EMA), respectively.  In both regions, PB016 is delivered in a lyophilised vial for intravenous administration and is indicated for the treatment of adults with moderately to severely active ulcerative colitis and Crohn’s disease.

The biosimilar was developed by Polpharma Biologics, and Fresenius Kabi holds the exclusive commercialisation rights (excluding the MENA region) under a global licensing agreement announced in August 2025.  Polpharma entered into a licensing agreement with MS Pharma for commercialisation of PB016 (and other biosimilars) in the MENA region in September 2025.

In February 2024, Polpharma announced that PB016 demonstrated pharmacokinetic and pharmacodynamic equivalence to Entyvio®.  A phase 3 trial comparing PB016 to Entyvio® in patients with ulcerative colitis was also undertaken.

The first FDA acceptance of a BLA for a vedolizumab biosimilar was in June 2026, for Alvotech’s AVT16 (lyophilised vial for IV administration).  AVT16 will be commercialised by Teva under a strategic partnership entered in August 2020 and expanded in 2023.  Alvotech also has a subcutaneous vedolizumab biosimilar under development (AVT80), with positive results from a PK study for the product announced in February 2026.

Other vedolizumab biosimilars are under development, including by Intas (Indian approval to conduct Phase I bioequivalence study of INTP53 in February 2025) and Samsung Bioepis (in early-stage development, global licence, development and commercialisation agreement (excluding certain Asian countries) entered with Sandoz in March 2026).

On 30 July 2026, Seoul Economic Daily reported that Celltrion is partnering with Korean-headquartered G2GBIO to convert antibody drugs to subcutaneous injection formulations.  The companies have signed a strategic memorandum of understanding, including a material transfer agreement, for “ultra-high concentration antibody SC formulation platform technology”.

As part of the collaboration, Celltrion and G2GBIO will evaluate G2GBIO’s InnoBioLAMP platform using Celltrion’s antibody assets and will explore joint development opportunities.  The InnoBioLAMP platform uses microparticle technology to convert intravenous antibody therapies into subcutaneous formulations.

In March 2026, G2GBIO entered into a research collaboration and licence agreement with Samsung Bioepis and its sister company, Epis NexLab, to develop long-acting semaglutide, with an option for Samsung Bioepis to licence another undisclosed G2GBIO asset.