On 10 July 2026, the FDA announced that it approved each of MSD’s Keytruda® (pembrolizumab) and Keytruda Qlex™ (pembrolizumab and berahyaluronidase alfa-pmph) in combination with Astellas’ Padcev® (enfortumab vedotin), as neoadjuvant treatment followed by adjuvant treatment after cystectomy for adults with muscle invasive bladder cancer (MIBC).  This approval extends the previous US approval for the regimen in this setting from cisplatin-ineligible patients to all patients with MIBC who are candidates for cystectomy.

The FDA’s review of the new Keytruda®/Keytruda Qlex™ indication was conducted under Project Orbis, in collaboration with the regulatory authorities of Australia, Canada, Switzerland, the UK and Israel.  The MIBC indication for cisplatin-ineligible patients was recently approved in Europe.

A day earlier, on 9 July 2026, the FDA announced another oncology approval, with Sanofi-Aventis’ Sarclisa Escena™ (isatuximab-irfc), a subcutaneous formulation of Sarclisa®, approved as the first anticancer treatment administered via an on-body injector.

Sarclisa Escena™ is approved in combination with standard-of-care regimens for the treatment of patients with multiple myeloma across all existing indications of the IV formulation of Sarclisa®.  The drug may be administered by manual SC administration or via the CirCLIQ® on-body injector.

While isatuximab biosimilars are some way off, pembrolizumab biosimilars are in development including by Samsung Bioepis, Formycon, Amgen, mAbxience, Sandoz, Celltrion, Bio-Thera, Shanghai Henlius, BioNTech, Qilu Pharmaceutical and Enzene.  They have reportedly also 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).

On 9 July 2026, PR Newswire reported that the FDA has approved Accord BioPharma’s Ennumo™, biosimilar to Amgen’s Neulasta® (pegfilgrastim), for all approved reference indications.

According to the announcement, Accord is now the only company in the US offering two distinct pegfilgrastim biosimilars to Amgen’s Neulasta®, Ennumo™ (pegfilgrastim-pccg) and Udenyca® (pegfilgrastim-cbqv).  Udenyca® was acquired by Intas Pharmaceuticals (Accord’s parent company) from Coherus Biosciences in August 2025.

There are a number of other pegfilgrastim biosimilars approved in the US, including Mylan/Biocon’s Fulphila® (approved June 2018, launched July 2018), Coherus/Accord’s Udenyca® (PFS approved November 2018, PFS launched January 2019; autoinjector approved March 2023, autoinjector launched May 2023; Udenyca OnBody® approved December 2023, launched February 2024), Sandoz’s Ziextenzo® (approved November 2019), Pfizer’s Nyvepria® (approved June 2020), Amneal/Kashiv’s Fylnetra™ (approved May 2022, launched May 2023), Fresenius’ Stimufend® (approved September 2022, launched February 2023) and Lupin’s Armlupeg™ (approved December 2025).

On 9 July 2026, Teva and Polpharma Biologics announced that they entered into an exclusive licensing agreement for the commercialisation of intravenous and subcutaneous formulations of Polpharma Biologics’ PB018, biosimilar to Roche’s Ocrevus® (ocrelizumab).

PB018 is currently in early development and has not yet entered clinical trials.  According to the US clinical trials database, Polpharma is planning to commence a Phase 1 study in October 2026 comparing PB018 with Ocrevus® in patients with multiple sclerosis.

Under the agreement, Swiss-based Polpharma Biologics will be responsible for the development, manufacture and supply of the ocrelizumab biosimilar, while Israeli-based Teva, will be responsible for regulatory submissions and commercialisation in the US, Europe, Brazil, Canada, Australia, New Zealand, Israel and Turkey.

Polpharma has previously entered into a licensing agreement with MS Pharma in relation to the commercialisation of PB018 (and other biosimilars) in the MENA region (September 2025).

Ocrelizumab biosimilars are in clinical trials sponsored by Amgen (Phase 3 underway, estimated primary completion in 2027), Biocad (Phase 3, enrolment commenced November 2025), Sandoz (Phase 3 trial underway, estimated primary completion in November 2026), Celltrion (Phase 3 IND for CT-P53 partially approved by the EMA in August 2023, currently recruiting, estimated primary completion dated in 2027) and R-Pharm (Phase 1 study commenced April 2025, estimated primary completion in January 2026).  In January 2026, Samsung Bioepis announced that it had added an ocrelizumab biosimilar to its pipeline.

On 8 July 2026, Shanghai Henlius Biotech announced that the first patient in China has been dosed in its multicentre Phase 1 clinical trial of HLX05-N, biosimilar to Eli Lilly/Merck KGaA’s Erbitux® (cetuximab).

The Phase 1 study, initiated in June 2026, is designed to evaluate the pharmacokinetic similarity, efficacy, safety and immunogenicity of HLX05-N compared with US- and EU-sourced Erbitux® in patients with metastatic colorectal cancer (mCRC).  Primary completion of the study is expected in June 2027.

The FDA approved the Investigational New Drug (IND) application for the Phase 1 trial in May 2026, shortly after the approval of Henlius’ IND by China’s National Medical Products Administration in April 2026.

No cetuximab biosimilars have been launched to date in China, the United States, Europe or Japan.  Alkem’s Cetuxa™ was reportedly the first cetuximab biosimilar to be approved and launched in India (January 2023 and May 2023, respectively).  Alkem’s biological arm, Enzene, entered into a strategic collaboration with Lupin in May 2023 for Indian commercialisation of Cetuxa™.  In February 2026, R-Pharm’s Arcetux™ (cetuximab) was the first biosimilar cetuximab to gain approval in Russia.

On 8 July 2026, Teva and Samsung Bioepis announced that they have entered an agreement for the commercialisation in Canada of Opuviz®/SB15 (aflibercept), biosimilar to Regeneron/Bayer’s Eylea®.  Under the terms of the licence and commercialisation agreement, Samsung Bioepis is responsible for the manufacture and registration of Opuviz®, while Teva has the Canadian commercialisation rights.

Samsung Bioepis had previously partnered with Biogen in relation to Opuviz® in Canada (and certain other countries) under a November 2019 agreement.  However, in October 2024, Biogen notified Samsung Bioepis of its decision to terminate that agreement for the US and Canada and the commercialisation rights reverted to Samsung Bioepis.

SB15 was approved in Canada in October 2025 but has not yet been launched on the Canadian market.  Samsung Bioepis entered settlement agreements with Regeneron/Bayer in relation to SB15 for the US & Canada (announced February 2026) and for Europe and ROW (announced January 2026), which provided agreed launch dates for SB15 in the jurisdictions covered by the agreements. However, the agreed launch date for Canada has not been made public.

Other aflibercept biosimilars approved in Canada include Biocon’s Yesafili® (June 2025, launched July 2025 following a settlement with Regeneron/Bayer), Amgen’s Pavblu® (July 2025), Apotex’s Aflivu™ (July 2025), Sandoz’s Enzeevu® (October 2025, launched February 2026), Celltrion’s Eydenzelt® (November 2025), and Formycon/Klinge/Valorum Biologics’ Ahzantive™ (November 2025).

Opuviz® was the third aflibercept biosimilar to be approved in the EU in November 2024 and was launched in Europe through direct sales in May 2026.  SB15 was approved in Korea (as Afilivu®) in February 2024 and in Australia (as Opuviz®) in September 2025.  Opuviz® was approved in the US in May 2024 and is set for a US launch from January 2027 under Samsung Bioepis’ settlement agreement with Regeneron/Bayer.

On 7 July 2026, Celltrion announced that it has successfully secured formulary listings for Vegzelma™, biosimilar to Roche/Genentech’s Avastin® (bevacizumab), with two major pharmacy benefit managers (PBMs) in the US.

Vegzelma™ was listed as a preferred drug on the government and commercial insurance formularies of Express Scripts (ESI) and on the government insurance formulary of Optum.  Reimbursement coverage for ESI and Optum’s government insurances came into effect on 1 July 2026, with coverage for ESI’s commercial insurance expected to come into effect in January 2027.

Vegzelma™ was approved by the FDA in September 2022.  According to Celltrion’s announcement, as of May 2026, Vegzelma™ had captured over 10% market share of the US bevacizumab sector through the open market, and it has now “secured coverage across more than 35% of the US insurance market” through the PBM formulary listings.

There are currently five other bevacizumab biosimilars approved in the US: Amgen’s Mvasi® (September 2017), Pfizer’s Zirabev® (June 2019), Amneal’s Alymsys® (April 2022), Bio-Thera/Sandoz’s Avzivi® (December 2023) and Biocon Biologics’ Jobevne™ (April 2025).  More recently, on 13 January 2026, Shanghai Henlius Biotech announced that a Biologics Licence Application for its bevacizumab biosimilar, HLX04, was accepted for review by the FDA.

On 6 July 2026, Novartis and Myricx Bio announced that they have entered into an agreement for the acquisition of Myricx Bio by Novartis.  Myricx Bio is a UK-based biotechnology company developing antibody-drug conjugates (ADCs) using N-myristoyltransferase inhibitor (NMTi) payloads.  Myricx has two lead assets under development, with potential across multiple solid tumour settings.

The transaction is expected to close in H2 2026, subject to closing conditions and regulatory approvals.  Under the terms of the agreement, Novartis will pay Myricx Bio USD1.1 billion cash up front, with up to USD400 million in potential milestone payments.

According to the companies, the acquisition of Myricx Bio will strengthen Novartis’ oncology pipeline, as ADCs have become an important part of cancer treatment.  Fiona Marshall, the President of Biomedical Research at Novartis stated that the “proposed acquisition reflects our strategy to scale innovative platforms, as we have with radioligand therapies, to deliver more durable, transformative treatments for patients.”

In February 2024, Novartis announced that it had agreed to acquire MorphoSys AG, a biopharmaceutical company focused on oncology medicines, for around €2.7B.

On 6 July 2026, Seoul Economic Daily reported that Celltrion has filed with the FDA an amendment to its global Phase 3 clinical trial plan for CT-P51, biosimilar to MSD’s Keytruda® (pembrolizumab).  The amendment reduces the number of trial participants from about 600 to around 220 as a result of “consultation with regulatory authorities”.

The Phase 3 trial plan was originally approved by the FDA in August 2024 and aims to compare the efficacy and safety of CT-P51 and Keytruda® in patients with previously untreated metastatic non-squamous non-small cell lung cancer.  The trial will be conducted over a period of 2 years.

Celltrion’s amendment to its Phase 3 trial plan comes a week after Samsung Bioepis announced positive results from its global Phase1 and Phase 3 clinical trials for SB27 (pembrolizumab).  According to Samsung Bioepis, it was the first developer of a pembrolizumab biosimilar to announce global phase 3 trial results.

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, Bio-Thera, 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 2 July 2026, Singaporean-headquartered Prestige Biopharma announced that it had signed a memorandum of understanding (MOU) with US-based Charles River Laboratories to collaborate on biopharmaceutical development, testing and manufacturing.

The collaboration will create an end-to-end service for the development and commercialisation of biosimilars and novel antibody therapies, by integrating Charles River’s discovery, pre-clinical and analytical testing with Prestige’s development and Contract Development and Manufacturing Organisation (CDMO) capabilities.

Additionally, the collaboration initiates a joint global business development strategy.  Under the terms of the MOU, Charles River will refer clients requiring biopharmaceutical process development and manufacturing to Prestige, while Prestige will connect clients in need of early-stage discovery, preclinical toxicology and bioanalytical services to Charles River.  The companies plan to utilise joint marketing initiatives to increase their global presence.

In 2023, Prestige Biologics entered into a non-binding MOU with a Dr. Reddy’s Laboratories subsidiary for the manufacturing, packaging and distribution of Dr. Reddy’s extensive biopharmaceutical pipeline in South Korea.

On 1 July 2026, The Korea Biomedical Review reported that Samsung Epis Holdings has opened and commenced operating its new research and development centre in Beijing.  The establishment of the new R&D centre was first announced by Samsung Epis on 29 May 2026.

The R&D centre is operated by Samsung Bioepis (China), a wholly owned subsidiary of Samsung Epis Holdings, and will serve as a global R&D hub supported by “world-class scientific talent and advanced technological infrastructure in China”.  The centre will have a strategic focus on securing antibody-drug conjugate (ADC) technology platforms and strengthening Samsung’s capabilities in new drug development.