Other Updates

On 6 October 2026, Celltrion announced the US launch of Omlyclo®, biosimilar to Genentech/Novartis’ Xolair® (omalizumab).  Omlyclo® is the first omalizumab biosimilar on the US market and is available in three dosage forms: 75 mg, 150 mg and 300 mg.

Omlyclo® was launched in the US at a wholesale acquisition cost (WAC) approximately 15% lower than that for the reference product, Xolair®.  It is listed as a preferred drug in the private insurance prescription book of Optum, a major US Pharmacy Benefit Manager (PBM).  According to Celltrion, it is also in negotiations with other PBMs.

Omlyclo® was first approved in the US in March 2025, in 75 mg/0.5ml and 150mg/ml PFS forms, with full interchangeable status.  The 300 mg formulation was FDA approved in December 2025.

The European launch of Omlyclo® in 75 mg and 150 mg dosage forms commenced in September 2025 and was completed in November 2025.  The high dose (300 mg) dosage form was launched in Europe in August 2026.  Omlyclo® to date remains the only omalizumab biosimilar approved in the EU, with Celltrion receiving EU market authorisation for its 75 mg/0.5 mL and 150 mg/1 mL PFS formulations in May 2024, and approval for the 300 mg formulation in November 2025

Omalizumab biosimilars in development include Kashiv BioSciences/Alvotech’s ADL-018/AVT23, with an application for ADL-018 accepted for review by Health Canada in June 2026 and marketing applications for AVT23 accepted by the UK’s MHRA in March 2025 and the European Medicines Agency in October 2025.  Under an exclusive licensing agreement with Kashiv entered in October 2023, Alvotech holds the commercialisation rights to ADL-018/AVT23 in Canada, together with the European Economic Area, UK, Switzerland, Australia and New Zealand.  Kashiv has entered into agreements for commercialisation of ADL-018 with Cristália for LATAM (August 2025) and MS Pharma for MENA markets (August 2025).

Teva’s biosimilar omalizumab applications have been accepted for review in the US and EU (March 2026) and CuraTeQ announced Phase 3 study results for its biosimilar omalizumab, BP11, in April 2026.  Mabpharm claims to have had an omalizumab biosimilar (Aomaishu®) approved for marketing in China in May 2023.

On 5 October 2026, Alvotech announced that the FDA has approved its supplement to the Biologics License Application for AVT02 (marketed as Simlandi® in the US), biosimilar to AbbVie’s Humira® (adalimumab). This approval allows drug manufacturing in a second production suite in Alvotech’s Reykjavik facility and will effectively double the manufacturing capacity available to support Alvotech’s biosimilar adalimumab supply in the US.

According to Alvotech, the FDA’s approval “further confirms” resolution of FDA inspection related matters at the Reykjavik site.  A July 2025 inspection had found deficiencies at the site, with the FDA then rejecting Alvotech’s golimumab (AVT05), aflibercept (AVT06), and denosumab (AVT03) BLAs in November 2025, December 2025 and January 2026, respectively.  After conducting a “remediation project” to address the FDA’s comments, Alvotech resubmitted its BLAs to the FDA in June 2026.  In July 2026, the FDA closed its inspection of the Reykjavik site with a Voluntary Action Indicated (VAI) classification (meaning objectionable conditions or practices were found, but the FDA did not take or recommend any administrative or regulatory action).

Alvotech expects the FDA to take action on its pending applications associated with the Reykjavik facility according to their respective goal dates, including for AVT16, biosimilar to Entyvio® (vedolizumab), which is currently the subject of pending BPCIA litigation.

On 1 October 2026, Fresenius SE announced that it has completed its acquisition of Spanish-based mAbxience by acquiring the remaining 45% stake in the company, having taken a 55% majority stake in 2022.  The acquisition was completed for up to €750 million, including a contingent payment of €50 million upon site-approvals.

mAbxience’s biosimilar platform is now wholly owned within Fresenius Kabi’s biopharma business, creating a vertically integrated business covering the full value chain from development and manufacturing to commercialisation.

mAbxience’s biosimilars to Amgen’s Prolia® and Xgeva® (denosumab), were approved in the US in December 2025 (as Boncresa™ and Oziltus™) and in Europe in July 2025 (as Izamby® and Denbrayce®).  Last month, mAbxience entered into a licensing, development, manufacturing and commercialisation agreement with Sandoz for a biosimilar to Roche/Chugai’s Hemlibra® (emicizumab).

On 1 October 2026, Celltrion’s Avtozma® (tocilizumab), biosimilar to Genentech’s Actemra®, became the first tocilizumab biosimilar to be listed on Australia’s Schedule of Pharmaceutical Benefits (PBS).  The PBS listing of Avtozma® will result in a mandatory 25% statutory price reduction for Actemra®.

Avtozma® was the first, and remains the only, tocilizumab biosimilar to be approved in Australia (May 2025).  It was launched in Korea in June 2025. in the US (IV formulation) in October 2025, and in Europe in January 2026.  The biosimilar has also been granted marketing authorisation in a number of other regions, including Japan (September 2022) and New Zealand (December 2025).

Celltrion additionally had the following products listed on the PBS on 1 October 2026:

• Yuflyma® (adalimumab), biosimilar to AbbVie’s Humira®, in a 20 mg/0.2 mL injection, 2 x 0.2 mL syringes format. Yuflyma® was approved by the TGA in this format in September 2024; and
• Omlyclo® (omalizumab), biosimilar to Genentech’s/Novartis’ Xolair®, for hospital use in 75 mg/0.5 mL injection, 0.5 mL pen device and 150 mg/mL injection, 1 mL pen device formats. Omlyclo® was approved by the TGA in each of these formats in November 2024/August 2025.

On 1 October 2026, Samsung Bioepis and Teva Pharmaceuticals announced a global collaboration and licence agreement to expand their existing partnership for up to six additional biosimilars.  The products covered by the agreement include SB44, biosimilar to Novartis’ Ilaris® (canakinumab), and SB41, biosimilar to AstraZeneca’s Fasenra® (benralizumab), plus four other undisclosed early-stage biosimilars.

Under the agreement, Samsung Bioepis is responsible for development, regulatory approval and manufacture, while Teva is responsible for commercialisation of the biosimilars in global markets including the US, Canada and Europe, with an option to expand the partnership to other territories.

Teva and Samsung Bioepis first entered into a strategic partnership in January 2025 for the US-commercialisation of Samsung Bioepis’ Epysqli® (eculizumab-aagh), biosimilar to Alexion’s Soliris®.  In July 2026, that agreement was expanded to include the commercialisation of Samsung Bioepis’ Opuviz® (aflibercept), biosimilar to Regeneron/Bayer’s Eylea®, in Canada.

No canakinumab biosimilars are reported to have been approved in major markets.  However, in May 2025, Alvotech and Advanz expanded their partnership to include the development and commercialisation of a canakinumab biosimilar in Europe.  Generium’s Limiris™ (canakinumab) was approved in Russia in September 2025, while it was reported in June 2026 that Belarusian company BioImmunity LLC obtained registration in Belarus of its canakinumab biosimilar and was seeking approval for the drug in Russia.

Benralizumab biosimilars are still in early development.  Enzene has a benralizumab biosimilar within its development pipeline.

On 30 September 2026, Korea Biomedical Review reported that MSD has launched Keytruda SC™ (pembrolizumab and berahyaluronidase alfa) in Korea and will begin shipping product starting on 1 October 2026.

Keytruda SC™ received approval from Korea’s Ministry of Food and Drug Safety in May 2026 for 35 indications across 18 cancer types, including lung cancer, triple-negative breast cancer, gastric cancer and endometrial cancer.

MSD’s subcutaneous pembrolizumab has been approved in a number of countries, including in the US as Keytruda Qlex™ (September 2025); in the EU (November 2025), Canada (February 2026), and Australia (July 2026), as Keytruda SC™; and in Japan as Keyject™ (September 2026).

MSD is currently engaged in disputes with Halozyme in relation to Keytruda SC™, with Halozyme alleging that MSD is infringing various patents to Halozyme’s MDASE™ subcutaneous delivery technology, including:

• in April 2024, Halozyme sued MSD in the US, alleging that MSD’s subcutaneous Keytruda® (Keytruda Qlex®) infringes 15 patents.  MSD has successfully invalidated claims of a number of Halozyme’s US patents before the Patent Trial and Appeal Board;
• in December 2025, the Munich Regional Court granted a preliminary injunction (PI) to Halozyme, preventing MSD from distributing and offering for sale in Germany Keytruda SC™; and
• in July 2026, the District Court of The Hague published a judgment dismissing Halozyme’s application for a PI to prevent MSD from marketing Keytruda SC™ (pembrolizumab and berahyaluronidase alfa) in Denmark and Sweden pending the outcome of substantive proceedings.

While there are no reports of biosimilar subcutaneous pembrolizumab development to date, there are multiple pembrolizumab (IV) biosimilars approved or in development.  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.

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 30 September 2026, the US District Court for the District of Delaware granted Janssen a preliminary injunction preventing Accord Biopharma and Bio-Thera Solutions from launching Immgolis™ and Immgolis Intri™ (BAT2506), biosimilars to Janssen’s Simponi® and Simponi Aria® (golimumab), in the US.  The reasons for the Court’s decision are not yet publicly available.

Accord and Bio-Thera have appealed the decision, with a Notice of Appeal filed on 1 October 2026.

Janssen originally commenced BPCIA proceedings against Accord and Bio-Thera on 3 March 2026, alleging that Accord/Bio-Thera’s (Immgolis™ and Immgolis Intri™ (BAT2506)) infringe 17 Janssen patents, relating to anti-TNF antibodies, manufacturing methods applicable to biologic drugs (including cell culture processes) and methods of treating ankylosing spondylitis and psoriatic arthritis with golimumab.

Janssen’s allegations regarding 4 method of treatment patents (11,014,982, 11,041,020, 12,122,824, 12,291,566) were subsequently dismissed by consent.  Accord and Bio-Thera filed petitions for inter partes review (IPR) of those 4 Janssen method of treatment patents on 20 March 2026 (IPR2026-00256, IPR2026-00257, IPR2026-00258, IPR2026-00259).  The IPRs were instituted by the Patent Trial and Appeal Board on 9 September 2026.

Janssen has also commenced BPCIA proceedings against Alvotech (19 June 2026), alleging Alvotech’s AVT05 (golimumab) infringes 14 patents.  Teva, Alvotech’s US commercialisation partner, was granted leave to intervene in the proceeding and has filed an application seeking a declaratory judgment of non-infringement and invalidity in relation to the 14 asserted patents.

Janssen filed a motion for preliminary injunction against Alvotech on 29 July 2026, arguing Alvotech infringes US 10,421,986, relating to a high cell density harvesting process.  The preliminary injunction hearing is to be scheduled for a date on or after 30 October 2026.

Immgolis™ and Immgolis Intri™ are the first and only golimumab biosimilars to have been FDA-approved (May 2026).  Alvotech resubmitted its BLA for AVT05 to the FDA in June 2026 after receiving a complete response letter in November 2025.

On 29 September 2026, the Australian Therapeutic Goods Administration (TGA) approved two aflibercept biosimilars sponsored by Actor Pharmaceuticals: Aflivu® and Ahzantive™.  Both brands are approved for all indications of the reference product, Regeneron/Bayer’s Eylea®, in 40 mg/mL solution for intravitreal injection vial and pre-filled syringe.

Actor entered into an exclusive licence agreement with Klinge Biopharma, the exclusive holder of the global commercialisation rights for Formycon’s FYB203 (aflibercept), in October 2025.  FYB203 is approved as Ahzantive® in the US (June 2024) and as Ahzantive® and Baiama® in Europe (January 2025).  Apotex commercialises an aflibercept biosimilar in Canada, under licence from Sam Chun Dang, under the brand name Aflivu® (approved June 2023, launched July 2025).

In August 2025, Actor commenced proceedings against Regeneron and Bayer in the Federal Court of Australia, seeking to invalidate Regeneron’s patent AU 2012205599 relating to methods of treatment using aflibercept.  Regeneron/Bayer cross-claimed for infringement.  However, those proceedings were discontinued by consent on 18 March 2026.

Actor’s aflibercept biosimilars join Celltrion’s Eydenzelt® (approved March 2025), Sandoz’s Afqlir® and Enzeevu® (approved May 2025) and Samsung Bioepis’ Opuviz® (approved September 2025), on the Australian Register of Therapeutic Goods.  Sandoz’s Afqlir® is currently the only biosimilar aflibercept listed on Australia’s Schedule of Pharmaceutical Benefits (PBS) (February 2026), although Celltrion’s Eydenzelt® was recommended for PBS listing in August 2026.

In November 2025, Regeneron/Bayer and Sandoz settled Australian aflibercept patent infringement/revocation proceedings on confidential terms.  The settlement followed the Australian Federal Court’s refusal to grant Regeneron/Bayer a preliminary injunction preventing the launch of Sandoz’s biosimilar aflibercept.

On 28 September 2026, STADA announced that it has entered into an exclusive partnership with Chia Tai Tianqing Pharmaceutical Group (CTTQ), a subsidiary of Sino Biopharmaceutical Limited, for up to four biosimilars. This includes CTTQ’s TQB3570, biosimilar to MSD’s Keytruda® (pembrolizumab), with an option for STADA to add up to three further immunology and oncology biosimilars.

Under the agreement, China-headquartered CTTQ is responsible for development, manufacture and supply, and STADA is responsible for marketing authorisations and exclusive commercialisation in the EU, Switzerland, UK and Commonwealth of Independent States, with options for the US and Gulf Cooperation Council member states.  The specific financial terms of the partnership have not been disclosed.

Competition is heating up in relation to the first pembrolizumab biosimilar to be approved in major markets.  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 this year.

Formycon has been taking a streamlined clinical development approach in relation to its pembrolizumab biosimilar, FYB206, announcing 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.

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 28 September 2026, Teva announced that it has strengthened its position in the biosimilars market with the FDA approval of its internally developed Degevma™ (denosumab-adet), biosimilar to Amgen’s Xgeva®.  Degevma™ is indicated for all approved reference indications and will be available as a 120mg/1.7mL solution for injection in a vial.

Teva’s biosimilar to Amgen’s Prolia® (denosumab) was approved in March 2026 as Ponlimsi™.  Both Degevma™ and Ponlimsi™ are anticipated to be launched in the US “in the coming months”.  The biosimilars were approved in the EU in November 2025.

The US has a highly competitive denosumab biosimilar market with numerous denosumab biosimilars already launched, including Sandoz’s Jubbonti® and Wyost® (approved March 2024, launched June 2025), Celltrion’s Stoboclo® and Osenvelt® (approved March 2025, launched July 2025), Fresenius Kabi’s Conexxence® and Bomyntra® (approved March 2025, launched July 2025), Shanghai Henlius/Organon’s Bildyos® and Bilprevda® (approved September 2025, launched October 2025), Biocon’s Bosaya™ and Aukelso™ (approved September 2025, launched October 2025), Gedeon Richter/Hikma’s Enoby™ and Xtrenbo™ (approved September 2025, launched January 2026), and Accord BioPharma’s Osvyrti® and Jubereq® (approved November 2025, launched July 2026).