On 26 June 2026, Replimune announced that its third submission of the Biologics License Application (BLA) for RP1 (vusolimogene oderparepvec) in combination with BMS’ Opdivo® (nivolumab) for the treatment of advanced melanoma has been accepted for review by the FDA.  A target date for the FDA’s decision has been set for 2 August 2026.

Replimune’s plan for resubmission was reported in May 2026, following the rejection of two earlier submissions in July 2025 (first Complete Response Letter (CRL) issued in response to a November 2024 BLA submission) and April 2026 (second CRL issued in response to an October 2025 BLA submission).

In May 2026, the FDA indicated it would treat Replimume’s BLA resubmission as an urgent matter upon receipt and would prioritise its review in recognition of the significant unmet need for patients in the advanced melanoma community.

On 26 June 2026, the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) announced the outcomes of its June 2026 meeting, including positive opinions for two biosimilars and recommended indication extensions for a number of biopharmaceuticals.

Ascend GmbH (a subsidiary of Alkem Laboratories) secured a CHMP positive opinion for “Denosumab Ascend”, biosimilar to Amgen’s Xgeva® (denosumab).  In November 2025, Alkem’s subsidiary, Enzene, received a CHMP positive opinion for Osqay®, biosimilar to Amgen’s Prolia® (denosumab).  Enzene and Theramex entered into an agreement in 2021 under which Enzene will supply Theramex with its denosumab biosimilar for commercialisation in Europe, the UK, Switzerland and Australia.  Alkem and Ascend are currently parties to BPCIA litigation commenced by Amgen in November 2025 following the filing of Alkem/Ascend’s BLA for biosimilar denosumab in the US.

The second biosimilar to be recommended by CHMP at its June 2026 meeting was Qilu Pharma’s Nylaspeg™, biosimilar to Amgen’s Neulasta® (pegfilgrastim).  The recommendation comes over 7 years after the approval of the first European pegfilgrastim biosimilar, Accord Healthcare’s Pelgraz®, in September 2018.

CHMP’s June 2026 positive opinions for extended indications include:

• Janssen’s Stelara® (ustekinumab) for the treatment of moderately to severely active ulcerative colitis in paediatric patients from the age of 2 years and older, who have had an inadequate response to, or were intolerant to either conventional therapy or a biologic.
• AstraZeneca/Daiichi Sankyo’s Datroway® (datopotamab deruxtecan) as a monotherapy, for the first-line treatment of adult patients with unresectable or metastatic triple-negative breast cancer (TNBC) who are not candidates for PD-1/PD-L1 inhibitor therapy; and
• Janssen’s Tecvayli® (teclistamab) 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 25 June 2026, MSD announced that the FDA has approved each of Keytruda® (pembrolizumab) and Keytruda Qlex™ (pembrolizumab and berahyaluronidase alfa-pmph), in combination with Gilead’s Trodelvy® (sacituzumab govitecan-hziy) for the first-line treatment of adults with unresectable locally advanced or metastatic triple-negative breast cancer (TNBC) whose tumours express PD-L1 (Combined Positive Score [CPS] ≥10) as determined by an FDA-authorised test.  According to the announcement, these approvals represent the first regimen of a PD-1 inhibitor plus Trop-2 directed antibody-drug conjugate (ADC) in advanced TNBC.

The US approvals came a day after it was announced that Keytruda® was approved in Europe, in combination with Astellas’ Padcev™ (enfortumab vedotin), as neoadjuvant treatment (before surgery) and then continued after radical cystectomy (surgery) as adjuvant treatment, for adults with resectable muscle-invasive bladder cancer (MIBC) who are ineligible for cisplatin-containing chemotherapy in the EU.

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 appears to be the front runner, having demonstrated pharmacokinetic bioequivalence with Keytruda® in its “Dahlia” study (reported in February 2026).  Formycon’s US commercialisation partner, Zydus, has 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 Samsung Bioepis, Amgen, mAbxience, Sandoz, Celltrion, 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 23 June 2026, Organon and Shanghai Henlius announced the Canadian launch of Bildyos® (denosumab injection, 60 mg/1 mL) and Tuzemty® (denosumab injection, 120 mg/1.7 mL), indicated for all approved reference indications of Amgen’s Prolia® and Xgeva®, respectively.

Bildyos® and Tuzemty® (HLX14) were approved in Canada in March 2026.  Organon was granted the exclusive commercialisation rights to Henlius’ denosumab biosimilars globally, “except for China; including Hong Kong, Macau and Taiwan”, under a June 2022 agreement.

Henlius/Organon have previously launched denosumab biosimilars in the US under the names Bildyos® and Bilprevda® (approved September 2025, launched October 2025).  Bildyos® and Bilprevda® were approved in the EU in September 2025.

Sandoz’s Wyost® (February 2024) and Jubbonti® (March 2024) were the first denosumab biosimilars approved in Canada, and were launched in August 2024.  This was followed by the Canadian approvals of Celltrion’s Stoboclo® and Osenvelt® (September 2025), Apotex’s Denoza™, biosimilar to Amgen’s Prolia®, (April 2026) and Biocon’s Bosaya™ and Vevzuo™ (April 2026).

On 22 June 2026, AbbVie and Apogee Therapeutics announced that they have entered into a definitive agreement for the acquisition by AbbVie of all outstanding shares of Apogee Therapeutics in an all-cash transaction valued at approximately USD$10.9 billion ($135.11 per share).

The transaction is expected to close in Q3/2026, subject to closing conditions including Apogee shareholder approval and receipt of regulatory approvals.

According to the companies, the acquisition of Apogee “holds potential for substantial shareholder value creation with mega-blockbuster peak sales potential across Apogee’s pipeline of assets”.

Apogee’s pipeline of assets includes zumilokibart (APG777) for the treatment of inflammatory diseases, including atopic dermatitis and asthma.  Zumilokibart is a subcutaneous antibody that is being positioned as a competitor to Eli Lilly’s Ebglyss® (lebrikizumab) and Regeneron/Sanofi’s Dupixent® (dupilumab).  In the Phase II clinical trial, zumilokibart demonstrated strong efficacy and a safety profile consistent with other medicines in its class.  Phase III trials are set to commence in 2026, with an anticipated commercial launch in 2029.

The acquisition of Apogee complements AbbVie’s current immunology portfolio, which includes Humira® (adalimumab), Skyrizi® (risankizumab) and Rinvoq® (upadacitinib) and generated $7.29 billion in the first quarter of 2026.

On 19 June 2026, Janssen filed a BPCIA complaint against Alvotech in the US District Court for the Eastern District of Virginia alleging that Alvotech’s golimumab biosimilars, AVT05 SC and IV, infringe 14 Janssen patents relating to Simponi® (SC), Simponi Aria® (IV) and the manufacture and delivery of biologic products like golimumab.

The proceedings follow 2 weeks after Alvotech announced on 4 June 2026 that it had resubmitted its AVT05 BLA to the FDA.  Janssen alleges that by submitting its BLA for AVT05 SC and AVT05 IV and “taking concrete steps to market those products, Alvotech has infringed, and threatens to infringe, Janssen’s patents”.

Alvotech’s BLA for AVT05 was first accepted for review by the FDA in January 2025.  Alvotech received a Complete Response Letter from the FDA in November 2025 and subsequently undertook a “remediation project”.  The golimumab BLA was then resubmitted following completion of an FDA “routine cGMP surveillance inspection” of Alvotech’s Reykjavik manufacturing facility in May 2026 and the provision by Alvotech of responses to observations raised as a result of that inspection.  AVT05 will be commercialised in the US by Teva under an August 2020 strategic partnership.

The litigation against Alvotech is the second BPCIA proceeding regarding golimumab commenced by Janssen, following a complaint filed against Bio-Thera Solutions and Accord BioPharma in March 2026.  That complaint alleges that Bio-Thera/Accord’s golimumab biosimilars (Immgolis™ and Immgolis Intri™ (BAT2506)), the first and only golimumab biosimilars to have been FDA-approved (May 2026), infringe 17 Janssen patents.

AVT05 was the first golimumab biosimilar to be approved worldwide in September 2025, with its approval in Japan as Gobivaz®.  Gobivaz® received a positive CHMP opinion from the EMA in September 2025, followed by approval in Europe and the UK in November 2025, where it is commercialised by Advanz Pharma.

On 19 June 2026, Chugai Pharmaceutical (a Roche subsidiary) announced that the Japanese Ministry of Health, Labour and Welfare has approved Rituxan® (rituximab) for adult-onset frequently relapsing or steroid-dependent nephrotic syndrome, and Avastin® (bevacizumab) for treatment of neurofibromatosis type 2.  Avastin® is now the first drug approved in the world for the treatment of neurofibromatosis type 2.

Rituxan® was approved in Japan in August 2014 for paediatric-onset refractory nephrotic syndrome (frequently relapsing or steroid-dependent), in September 2024 for steroid-resistant paediatric-onset refractory nephrotic syndrome, and in March 2025 for paediatric-onset non-refractory frequently relapsing or steroid-dependent nephrotic syndrome.

Chugai currently co-promotes Rituxan® in Japan with Zenyaku Kogyo, which is the marketing authorisation holder.  However, in April 2026, Chugai and Zenyaku announced that they have terminated their co-promotion in Japan for Rituxan®, effective from 3 September 2026, at which time Zenyaku will assume sole responsibility for sales of Rituxan® in Japan.

Rituximab was one of the first mAbs to become “biosimilar”.  Both Pfizer and Sandoz/Kyowa Kirin market rituximab biosimilars in Japan.  Bevacizumab biosimilars have also been marketed in Japan for some time, including by Celltrion (Vegzelma™, launched January 2023) and Daiichi Sankyo/Amgen (bevacizumab BS for intravenous drip infusions, launched December 2019).

On 19 June 2026, The Asia Business Daily reported that Alteogen Biologics’ MENA region partner, SPIMACO, has received product approval for ALT-L9 (aflibercept), biosimilar to Regeneron/Bayer’s Eylea® (2 mg) from the Saudi Food and Drug Authority (SFDA).

The SFDA is a major regulatory agency in the Middle East and many MENA countries refer to SFDA approval results during their own regulatory review processes.  Alteogen therefore expects that the Saudi Arabian approval will expedite approval of ALT-L9 in other key MENA countries, including the United Arab Emirates, where regulatory review is underway.

ALT-L9 is the first biosimilar developed by Alteogen.  Alteogen entered into an exclusive agreement with SPIMACO in 2024 for the commercialisation rights to ALT-L9 in 16 MENA countries.

ALT-L9 was approved in Europe as Eyluxvi® in September 2025, following a positive CHMP opinion in July 2025.  In May 2026, Alteogen announced that the Korean Ministry of Food and Drug Safety had approved ALT-L9 as Eyzanfy™, 20 months after Alteogen had submitted its Korean marketing authorisation application in September 2024.

There are currently other established partnerships in relation to the commercialisation of aflibercept biosimilars in the MENA region.  This includes Formycon and MS Pharma, which partnered in May 2024 in relation to the commercialisation of Formycon’s FYB203 (aflibercept) in MENA, and Bioventure and Amman Pharmaceutical Industries, which entered into a licence agreement in 2023 under which Amman Pharma was granted exclusive rights to register and commercialise the Alvotech-developed aflibercept biosimilar in the Levant region.

On 18 June 2026, Samsung Bioepis and Organon announced the expansion of their development and commercialisation agreement for Canada to include Samsung Bioepis’ Pyzchiva® (SB17), biosimilar to J&J’s Stelara® (ustekinumab).  Current plans are for Pyzchiva® to be launched in Canada during 2026.

Under the terms of the expanded agreement, Organon will obtain the exclusive Canadian commercialisation rights to Pyzchiva®, while Samsung Bioepis retains full development, manufacturing, and regulatory responsibilities.

The new agreement expands the biosimilar portfolio under Samsung Bioepis and Organon’s collaboration in Canada (first established in 2013) from five to six biosimilars.  In addition to Pyzchiva®, the biosimilars encompassed by the agreement are Hadlima® (adalimumab; launched 50mg/mL in March 2021; 100mg/mL approved August 2022), Brenzys® (etanercept; approved September 2016), Renflexis® (infliximab; launched March 2018), Aybintio® (bevacizumab; launched November 2022), and Ontruzant® (trastuzumab; launched November 2022).

Samsung Bioepis had previously entered into an exclusive agreement with Sandoz in September 2023 for the development and commercialisation of SB17 in the US, Canada, EEA, Switzerland and the UK.  Sandoz launched Pyzchiva® in Europe in July 2024 and in the US in February 2025.

Pyzchiva® was approved in Canada in August 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), Fresenius’ Otulfi® (approved January 2025, launched May 2025), Biocon’s Yesintek™ (approved October 2025, launched mid-October 2025) and Dong-A ST/Intas’ Imuldosa™ (approved January 2026, not yet launched).

On 18 June 2026, CSPC Pharmaceutical Group announced that China’s National Medical Products Administration (NMPA) has accepted its marketing authorisation application (MAA) for Secukinumab Injection, biosimilar to Novartis’ Cosentyx®.

Cosentyx® is approved in China for the treatment of plaque psoriasis in patients aged 6 years and older; and for psoriatic arthritis, ankylosing spondylitis, hidradenitis suppurativa and non-radiographic axial spondyloarthritis in adults.  According to the announcement, In phase 1 and 3 studies, CSPC’s biosimilar demonstrated high similarity to Cosentyx® in terms of efficacy, safety, pharmacokinetics, and immunogenicity.

This news follows Celltrion’s announcement earlier in June 2026 that it has filed an application for its secukinumab biosimilar (CT-P55) in Canada, seeking all approved reference indications.  Celltrion is planning additional regulatory filings for CT-P55 in the US, Europe and Korea.

Other secukinumab biosimilars are under development, including Bio-Thera’s BAT2306 (phase 1 trial completed in 2023, phase 3 clinical trial in plaque psoriasis completed in 2024, commercialisation agreement with Dr Reddy’s in November 2025), Taizhou Mabtech Pharmaceutical’s CMAB015 (phase 1 trial completed in 2023) and Livzon Pharmaceutical Group’s LZM012 (phase 3 clinical trial in plaque psoriasis commenced).