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.

On 30 July 2026, Chicago-headquartered Meitheal Pharmaceuticals announced that the FDA has approved Garzulys™ (insulin aspart-fsan) injection, biosimilar to Novo Nordisk’s NovoLog®.  Garzulys™ is indicated to improve glycaemic control in adult and paediatric patients with diabetes mellitus and is approved for both intravenous and subcutaneous administration.

Garzulys™ was developed by China-based Tonghua Dongbaou Pharmaceutical and companies affiliated with Meitheal.  The Biologics License Application (BLA) is held by Emerge Biosciences.  Meitheal is the US regulatory agent with exclusive US commercialisation rights for Garzulys™ under a 2023 licence agreement with Emerge.

According to Meitheal, the FDA approval of Garzulys™ advances the company’s strategy to expand its established generic injectable business and build a broader portfolio of biologics and branded products.  Meitheal is also commercialising Yusimry™, biosimilar to AbbVie’s Humira® (adalimumab) in the US after the product was divested from Coherus BioSciences to Hong Kong Friend, Meitheal’s parent company, in June 2024.  A high concentration formulation of Yusimry™ is in development.  Meitheal is also partnering with Boan Biotech on denosumab biosimilars, for which a regulatory submission has been lodged.

Sanofi-Aventis’ Merilog™/Merilog™ SoloStar were the first US approved biosimilars to NovoLog® in February 2025.  In July 2025, Biocon Biologics announced that the FDA approved Kirsty™ (insulin aspart-xjhz) as the first and only interchangeable insulin aspart biosimilar.

On 29 July 2026, Alvotech announced that the US FDA has closed its inspection of Alvotech’s manufacturing facility in Reykjavik, Iceland with the inspection classification “Voluntary Action Indicated (VAI)”.  The routine cGMP surveillance inspection was conducted in May 2026.

The VAI classification means objectionable conditions or practices were found during the inspection, however the FDA did not take or recommend any administrative or regulatory action.   Alvotech’s CEO, Lisa Graver, stated that “the actions we have taken have effectively addressed the observations identified”.

Alvotech resubmitted its BLAs for AVT05 (golimumab) and AVT06 (aflibercept) to the FDA in June 2026.  This followed the receipt of Complete Response Letters from the FDA for Alvotech’s golimumab, aflibercept, and denosumab (AVT03) BLAs in November 2025, December 2025 and January 2026, respectively, and a subsequent  “remediation project” undertaken by Alvotech to address the FDA’s comments.

On 29 July 2026, Biocon announced that it has received Notice of Compliance (NOC) approval from Health Canada for ustekinumab (Yesintek®), biosimilar to Janssen’s Stelara®, in an autoinjector pen format (45 mg/0.05mL and 90 mg/mL).

Yesintek® was first approved in Canada in October 2025 in the following formulations: solution for subcutaneous injection, 45 mg/0.5mL (prefilled syringe and vial) and 90 mg/mL (prefilled syringe); and solution for intravenous infusion, 130 mg/26mL (5 mg/mL).  The product was launched in Canada in the same month.

On 29 August 2024, Biocon announced that it signed a patent settlement and licence agreement with Janssen for Canada, Japan, Europe and the UK.  Yesintek® was approved in the US in early December 2024, and was subsequently launched in February 2025, following a US settlement entered in February 2024.

Other ustekinumab biosimilars approved and launched in Canada to date, include JAMP/Alvotech’s Jamteki® (approved November 2023, launched March 2024), Amgen’s Wezlana® (approved December 2023, launched March 2024), Celltrion’s Steqeyma® (approved July 2024, launched August 2024, with an autoinjector form approved in March 2026), Fresenius’ Otulfi® (approved January 2025, launched May 2025), Samsung Bioepis’ Pyzchiva™ (approved August 2024, 2026 launch planned) and Dong-A ST/Intas’ Imuldosa™ (approved January 2026, not yet launched).

On 29 July 2026, Sandoz announced that Brazil’s Agência Nacional de Vigilância Sanitária (ANVISA) has approved Owozy® (semaglutide), a generic version of Novo Nordisk’s Ozempic®, for type 2 diabetes.  Sandoz is expecting to launch the product in the second half of 2026.

Owozy® was developed by Malta-headquartered Adalvo and will be commercialised in Brazil by Sandoz in a pre-filled, multi-dose disposable pen.  The Brazilian market for GLP-1 is estimated to be worth USD 1.8 billion, with more than 16.5 million Brazilians living with diabetes.

The Brazilian approval comes just weeks after Sun Pharma’s generic semaglutide injection was approved in South Africa (announced 15 July 2026), with launch following shortly thereafter.  A number of generic semaglutide products have also launched in India and Canada.  In March 2026, Dr Reddy’s, Zydus, Alkem, Sun Pharma and Glenmark launched generic semaglutide products on the Indian market, following the expiry of Novo Nordisk’s core Indian patent for semaglutide.  Generic semaglutide products were launched in 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.  Novo Nordisk has sued Apotex in the US in relation to generic Rybelsus®, Ozempic® and Wegovy®, alleging patent infringement, with the three cases being consolidated in June 2026.  Novo Nordisk also commenced Hatch Waxman litigation against Cipla in July 2026 in relation to generic semaglutide products.

On 29 July 2026, the EPO published the Board of Appeal’s decision of 6 May 2026 upholding the Opposition Division’s 13 March 2024 revocation of EP 3 288 980, for a composition comprising nivolumab for use in a method of treating PD-L1-positive melanoma.  The patent was opposed by 5 “strawperson” opponents.

The Boards of Appeal concluded that the claimed subject-matter of the patent, in particular the combination of nivolumab monotherapy and a flat-dose regimen (480 mg once every four weeks), extended beyond the content of the application as filed and did not meet the requirements of Article 123(2) of the EPC.

Multiple 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, and NeuClone’s candidate.

On 28 July 2026, AstraZeneca announced that India’s Central Drugs Standard Control Organisation (CDSCO) has approved an indication extension for Enhertu® (trastuzumab deruxtecan), followed by taxane, trastuzumab and pertuzumab (THP)), for the neoadjuvant treatment of HER2-positive stage 2 or 3 breast cancer.  This follows the conditional approval granted in China in March 2026 for Enhertu® followed by paclitaxel, trastuzumab and pertuzumab (THP) for the same indication.

Enhertu® was approved in India in May 2025 for the treatment of adult patients with unresectable or metastatic HER2-low or HER2-ultralow breast cancer, who have previously received at least one endocrine therapy in metastatic setting.

Enhertu® is the subject of a collaboration between AstraZeneca and Daiichi Sankyo entered in March 2019, under which the companies jointly develop and commercialise trastuzumab deruxtecan globally, except in Japan where Daiichi Sankyo maintains exclusive rights.  Daiichi Sankyo is solely responsible for manufacturing and supply.

Samsung Epis announced in January 2026 that Samsung Bioepis is adding a trastuzumab deruxtecan biosimilar to its pipeline, with the product in early stage development in preparation for pre-clinical trials.