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 4 June 2026, Alvotech announced that it has resubmitted to the FDA its Biologics License Applications for AVT05 (golimumab), biosimilar to Janssen’s Simponi® and Simponi Aria®, and AVT06 (aflibercept), biosimilar to Regeneron/Bayer’s Eylea®, 2mg.  Alvotech expects the FDA to conduct a 6-month review of the resubmitted BLAs, in line with applicable regulatory timelines.  Both AVT05 and AVT06 will be commercialised in the US by Teva.

The BLAs were resubmitted following completion of an FDA “routine cGMP surveillance inspection” of Alvotech’s Reykjavik manufacturing facility and the provision by Alvotech of responses to observations raised as a result of that inspection.  Alvotech received Complete Response Letters from the FDA for its golimumab, aflibercept, and denosumab (AVT03) biosimilar BLAs in November 2025, December 2025 and January 2026, respectively, and subsequently undertook a “remediation project”.

Alvotech’s BLA for AVT05 was first accepted for review by the FDA in January 2025.  In September 2025, AVT05 was the first golimumab biosimilar to be approved worldwide, 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.  Accord BioPharma’s Immgolis™ and Immgolis Intri™ were the first golimumab biosimilars approved in the US in May 2026, although their launch date is uncertain given ongoing BPCIA litigation commenced by Janssen against Accord/Bio-Thera in March 2026.

AVT06 (aflibercept, 2mg) has a Q4/2026 US launch date (subject to FDA approval) under a settlement agreement between Alvotech and Regeneron/Bayer.  AVT06 has already been launched in Germany (under the name Afiveg®) and in the UK, Canada and Japan (under the name Mynzepli®).  The only biosimilar aflibercept currently on the market in the US is Amgen’s Pavblu™, which launched 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 the biosimilar.  There are a number of approved aflibercept biosimilars, some of which have scheduled H2 2026 launch dates as a result of litigation settlements, including Biocon’s Yesafili® (approved May 2024, due to launch H2/2026), Formycon/Klinge’s Ahzantive® (approved June 2024, due to launch Q4/2026), Sandoz’s Enzeevu® (approved August 2024, due to launch Q4/2026), and Celltrion’s Eydenzelt® (approved October 2025, due to launch Q4/2026).

Dr Reddy’s, Alvotech’s partner in the US for AVT03, biosimilar to Amgen’s Prolia® and Xgeva® (denosumab), is responsible for resubmitting the BLA for that biosimilar.  AVT03 is currently the subject of BPCIA litigation commenced by Amgen in November 2025 alleging infringement of 31 US patents.

On 18 May 2026, Accord BioPharma announced that the FDA has approved Immgolis™ and Immgolis Intri™ (golimumab) as interchangeable biosimilars to Janssen’s Simponi® and Simponi® Aria, respectively.  These are the first golimumab biosimilars to be approved in the US.

The BLA for Bio-Thera/Accord’s golimumab biosimilar was accepted by the FDA for review in July 2025, which followed FDA acceptance of Alvotech/Teva’s BLA for AVT05 (golimumab) in January 2025.  However, Alvotech/Teva’s approval was delayed by a Complete Response Letter issued in November 2025, following which Alvotech undertook a “remediation project”.  Alvotech plans to resubmit its golimumab BLA to the FDA in Q2/2026.

Immgolis™ and Immgolis Intri™ were developed by Bio-Thera Solutions as BAT2506.  In February 2025, Bio-Thera and Intas Pharmaceuticals entered into an exclusive US commercialisation and licence agreement for BAT2506, under which Intas’ subsidiary Accord BioPharma is responsible for commercialising the product in the US, while Bio-Thera retains responsibility for development, manufacturing and supply.

The US launch date for Immgolis™ and Immgolis Intri™ is uncertain given ongoing US litigation relating to BAT2506.  In March 2026, Janssen commenced BPCIA patent infringement proceedings against Bio-Thera Solutions/Accord BioPharma alleging infringement of 17 patents.  A preliminary injunction application by Janssen is due to be heard in August or the beginning of September 2026.

Bio-Thera received a positive CHMP opinion in December 2025 for BAT2506, which was EU approved in February 2026 under the name Gotenfia®.  Gotenfia® is commercialised in the EU and UK by STADA.

On 11 May 2026, Alvotech announced plans to resubmit Biologics License Applications for aflibercept (AVT06), denosumab (AVT03) and golimumab (AVT05) biosimilars in the US, following completion of an FDA “routine cGMP surveillance inspection” of the Alvotech Iceland manufacturing facility.

According to Alvotech, although the FDA issued Form 483 observations at the conclusion of its inspection, the observations “can be addressed quickly and do not raise any substantial issues with the site or its operations”.  Alvotech expects to resubmit the BLAs in Q2/2026, and to secure approvals by the end of 2026.

Alvotech received Complete Response Letters from the FDA for its golimumab, aflibercept, and denosumab biosimilars BLAs in November 2025, December 2025 and January 2026, respectively, and subsequently undertook a “remediation project”.

Alvotech’s AVT05 (golimumab), biosimilar to Janssen’s Simponi®, was the first golimumab biosimilar to be approved worldwide, with its September 2025 approval in Japan.  In the US, AVT05 will be commercialised by Teva, with the BLA for AVT05 initially accepted for review by the FDA in January 2025.

AVT06, biosimilar to Regeneron/Bayer’s Eylea® (aflibercept, 2mg) has a Q4/2026 US launch date (subject to FDA approval) under a settlement agreement with Regeneron/Bayer.  AVT06 has already been launched in Germany (under the name Afiveg®) and in the UK, Canada and Japan (under the name Mynzepli®) and will be commercialised in the US by Teva.

Alvotech’s AVT03 (denosumab), biosimilar to Amgen’s Prolia® and Xgeva®, is embroiled in BPCIA litigation commenced by Amgen in November 2025.  Amgen’s complaint against Alvotech and its US commercialisation partner, Dr Reddy’s, alleges infringement of 31 US patents covering denosumab, pharmaceutical compositions of denosumab, methods of manufacturing therapeutic proteins like denosumab, and denosumab products.

On 20 April 2026, PR Newswire reported that Health Canada has approved JAMP Pharma’s Upgolyv™, biosimilar to Janssen’s Simponi® (golimumab), for the treatment of chronic inflammatory autoimmune diseases.  Upgolyv™ is the first golimumab biosimilar to be approved in Canada.

Clinical studies relied on by JAMP Pharma in its application for approval of Upgolyv™, AVT05-GL-P01 (NCT05632211) and AVT05-GL-C01 (NCT05842213), were sponsored by Alvotech, and were conducted with the Alvotech-developed golimumab biosimilar, AVT05.  It is therefore apparent that Upgolyv™ is being commercialised by JAMP Pharma in Canada via an association with Alvotech.  In March 2026, Alvotech confirmed during its Q4/2025 Earnings call that an application for approval of AVT05 had been filed in Canada, with a decision expected in H1 2026, although no commercialisation partner was mentioned at that time.

Alvotech and JAMP Pharma have previously partnered on the Canadian launch of Jamteki® (biosimilar ustekinumab) and announced their exclusive partnership for the commercialisation of five biosimilars in Canada in January 2020, expanded to seven biosimilars in October 2022.

Alvotech’s Gobivaz® (AVT05) was the first golimumab biosimilar approved worldwide in September 2025 in Japan.  The launch of Gobivaz® in Japan (commercialised by Fuji Pharma) is planned for May 2026.  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.  In the US, where AVT05 will be commercialised by Teva, the FDA issued a Complete Response Letter (CRL) for the biosimilar in November 2025.

Bio-Thera’s Gotenfia®/BAT2506 (golimumab ), marketed by STADA in the EU and UK, received a positive CHMP opinion in December 2025 and EU approval in February 2026.  Bio-Thera’s BLA for BAT2506 was accepted for review by the FDA in July 2025.  However, there is ongoing US litigation relating to BAT2506, with Janssen having filed proceedings against Bio-Thera Solutions/Accord BioPharma, alleging infringement of 17 patents.  A preliminary injunction application by Janssen is due to be heard in August or the beginning of September 2026.

On 23 March 2026, Bio-Thera Solutions announced that it has entered an exclusive agreement with Intas Pharmaceuticals for the Indian commercialisation of BAT2506 (golimumab), biosimilar to J&J’s Simponi®.  According to Bio-Thera, this represents its first biosimilar partnership for supply in India.

The agreement expands upon the companies’ existing exclusive partnerships for the commercialisation and licence of BAT2506 in the US (February 2025) and Canada (October 2025). Bio-Thera has entered commercialisation agreements for BAT2506 in other regions, including SteinCares for Latin America (March 2024), STADA for Europe, the UK and selected other countries (May 2024) and Dr Reddy’s for South East Asia (March 2025).

Bio-Thera’s BLA for BAT2506 was accepted for review by the FDA in July 2025.  In February 2025, Bio-Thera/STADA’s European Marketing Authorisation Application (MAA) for BAT2506 was accepted by the European Medicines Agency (EMA) and in December 2025, it received a positive CHMP opinion.

There is ongoing US litigation relating to Bio-Thera’s biosimilar golimumab.  On 3 March 2026, Janssen filed proceedings against Bio-Thera Solutions/Accord BioPharma in the US District Court for the District of Delaware, alleging infringement of 17 patents related to Bio-Thera’s biosimilar golimumab.

On 20 March 2026, Accord BioPharma, Intas Pharmaceuticals and Bio-Thera Solutions together filed four petitions for Inter Partes Review of Janssen’s US patent numbers 12,291,566 (IPR2026-00259), 12,122,824 (IPR2026-00258), 11,041,020 (IPR2026-00257) and 11,014, 982 (IPR2026-00256) in respect of methods of treatment using Simponi®/Simponi Aria® (golimumab).

The challenged patents are 4 of 17 patents asserted against Bio-Thera and Accord in BPCIA litigation commenced by Janssen in the US District Court for the District of Delaware on 3 March 2026.  In the US litigation, Janssen’s Complaint (published in redacted form on 11 March 2026) alleges that, by submitting an abbreviated Biologics Licence Application (aBLA) for BAT2506 to the FDA (which was accepted for review in July 2025), and “taking concrete steps to commercially market” the product, Bio-Thera and Accord have infringed and threatened to infringe Janssen’s patents.  Janssen is seeking a preliminary injunction (PI) in relation to 1-3 of the asserted patents and has proposed a hearing date for the PI of August/September 2026.

Bio-Thera entered into an exclusive US commercialisation and licence agreement regarding BAT2506 (golimumab) with Intas Pharmaceuticals, announced on 10 February 2025.  Under the agreement, Intas Pharmaceuticals’ subsidiary Accord BioPharma is responsible for commercialising the product in the US, while Bio-Thera retains responsibility for development, manufacturing and supply of BAT2506.  Bio-Thera received an upfront payment of US$21 million and will receive further development and commercial milestone payments of up to US$143.5 million.

BAT2506 was approved in Europe, under the name Gotenfia®, in February 2026.  Gotenfia® is being commercialised in Europe by STADA under a May 2024 agreement.  It was the second golimumab biosimilar to be approved in Europe, following the approval of Alvotech/Advanz’s Gobivaz® (AVT05) in November 2025.

Alvotech received a Complete Response Letter (CRL) from the FDA in relation to its US regulatory application for AVT05 (golimumab).  According to Alvotech, it is on track to resubmit its application in the first half of 2026.  AVT05 is being commercialised in the US by Teva pursuant to a strategic partnership entered into with Alvotech in August 2020.

During its Q4/2025 Earnings Call on 19 March 2026, Alvotech provided updates on its launch plans and regulatory applications for various biosimilars, including golimumab, aflibercept, vedolizumab and pembrolizumab.

Alvotech confirmed that Gobivaz® (AVT05) was launched in the EU in December 2025 as the first available biosimilar to J&J’s Simponi® (golimumab), following its November 2025 EU marketing authorisation.  Gobivaz® is being commercialised by Advanz Pharma in the UK and Europe under a May 2023 licence and supply agreement with Alvotech.  In Japan, Alvotech’s commercialisation partner, Fuji Pharma, is planning to launch Gobivaz® (approved in September 2025) in May 2026.  An application for approval of AVT05 has also been filed in Canada, with a decision expected in H1 2026.  To date, the application for AVT05 is the only known golimumab biosimilar application filed in Canada.

Alvotech indicated that it is aiming to file the first regulatory submission for its high dose aflibercept biosimilar, AVT29, sometime in 2026.  AVT29, biosimilar to Regeneron/Bayer’s Eylea™ 8mg/Eylea HD®, will be commercialised by Advanz Pharma in the EU and by Teva in the US.  Under settlement agreements with Regeneron/Bayer, Alvotech has a Q4/2026 US launch date for AVT06 (biosimilar to Regeneron/Bayer’s Eylea® (aflibercept), 2mg), subject to FDA approval, and various 2026 launch dates, with its partners STADA and Advanz Pharma having already launched AVT06 in Germany (under the name Afiveg®) and in the UK, Canada and Japan (under the name Mynzepli®), respectively.

Following the recent announcement of positive results from its PK study for AVT80, biosimilar to Takeda’s Entyvio® (vedolizumab), Alvotech said that it is planning to file regulatory submissions for a vedolizumab biosimilar later in 2026.  Alvotech expects to be among the first to launch an Entyvio® biosimilar and has both IV (AVT16) and SC (AVT80) formulations in development.

As previously reported, Alvotech has a biosimilar to MSD’s Keytruda® (pembrolizumab) in its pipeline, on which it is partnering with Dr Reddy’s.  During the Q4 2025 Earnings Call, Alvotech said that it is expecting it will be in a position to file a marketing authorisation application for the pembrolizumab biosimilar in 2028.

Alvotech also provided an update on the Complete Response Letters it received from the FDA in relation to its denosumab, golimumab and aflibercept biosimilars, announcing that it has undertaken a remediation project and is on track to resubmit its applications to the FDA in the first half of 2026.

On 3 March 2026, Janssen Biotech Inc and Janssen Sciences Ireland UC filed proceedings against Bio-Thera Solutions and Accord BioPharma in the US District Court for the District of Delaware, alleging infringement of 17 patents related to golimumab.  The Court has granted Janssen’s motion to file the complaint under seal and requires a redacted version to be filed by 11 March 2026. Summons were issued to Accord BioPharma on 4 March 2026, with an answer to the Court due on 25 March 2026.

On 16 July 2025, On 16 July 2025, Bio-Thera announced that the FDA had accepted its BLA for BAT2506, biosimilar to Janssen’s Simponi® (golimumab).  BAT2506 is being developed and manufactured by Bio-Thera and will be commercialised in the US by Intas Pharmaceuticals’ subsidiary, Accord Biopharma, under a February 2025 agreement.

Bio-Thera has entered into the following commercialisation agreements for BAT2506, including with SteinCares for Latin America (March 2024), STADA in Europe, the UK and selected other countries (May 2024), and Dr Reddy’s for South East Asia (March 2025).

In February 2025, Bio-Thera/STADA’s European Marketing Authorisation Application (MAA) for BAT2506 was accepted by the European Medicines Agency (EMA) and in December 2025, it received a positive CHMP opinion.

On 13 February 2026, STADA and Bio-Thera Solutions announced that the European Commission has granted marketing authorisation for Gotenfia®, biosimilar to Janssen’s Simponi® (golimumab).  According to the announcement, plans are underway to launch Gotenfia® in Europe “in the coming weeks and months”.

Gotenfia® received a positive recommendation from the EMA’s CHMP in December 2025 for the treatment of rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, axial spondyloarthritis and ulcerative colitis.  It is the second golimumab biosimilar to be approved in Europe, following the approval of Alvotech/Advanz’s Gobivaz® in November 2025.

Gotenfia®/BAT2506 was developed by Bio-Thera and is being commercialised by STADA in Europe under a May 2024 agreement.