Generic selectors
Exact matches only
Search in title
Search in content
Post Type Selectors
Filter by Categories
BioBlast®
Biosimilar Deals 2025
Biosimilars Deals 2023
Biosimilars Deals 2024
Chris Vindurampulle
Diversity
Helen Macpherson
Intranet
Kimberley Evans
Masterclasses
Other Podcasts
Other Updates
Our Awards
Patent Case Summaries
Patent Litigation
Patents
Paul Johns
PipCast®
PTE
Trade Marks
Webinars

Home / News / Other Updates

EXPLORE OUR

Other Updates

Explore our interactive biosimilar news updates, collating tailored reports by brand, INN, originator/biosimilar applicant, litigation, region, or date. Alternatively, review our weekly BioBlast™ updates below.

2025

July 21, 2025

With a number of biosimilars to MSD’s Keytruda® (pembrolizumab) currently in clinical trials, we provide the following update on those trials and their status, based on previous reports and the information available to date in the clinicaltrials.gov registry:

(a) Samsung Bioepis (SB27): Ph 3 study to compare efficacy, safety, PK and immunogenicity between SB27 and Keytruda® in patients metastatic nsNSCLC initiated in April 2024. The study is currently recruiting with estimated primary completion in September 2025.

(b) Amgen (ABP 234): Ph 3 study in nsNSCLC initiated May 2024 to compare PK between ABP 234 and Keytruda® in patients with early-stage nsNSCLC as adjuvant treatment following resection and platinum-based chemotherapy. The study is currently recruiting, with estimated primary completion in March 2026Ph 3 study commenced in September 2024 to compare the efficacy, PK, safety and immunogenicity between ABP 234 and Keytruda® in patients with advanced or metastatic nsNSCLC.  The study is currently recruiting, with estimated primary completion in February 2028.

(c) Formycon (FYB206): Integrated Ph1/3 study commenced in June 2024 to demonstrate PK similarity of FYB206 with Keytruda® in patients with Stage IIB/IIC or Stage III melanoma. On 10 July 2025, Formycon announced that it had completed patient enrolment.  Formycon expects results to be available in Q1 2026.  Formycon had originally intended to conduct a parallel Phase 3 trial to compare the safety and efficacy of FYB206 with Keytruda® in NSCLC.  However, in February 2025, Formycon announced the premature termination of the Phase 3 trial on the basis that the trial was not necessary to obtain US approval of FYB206.

(d) mAbxience (MB12): Ph 3 study to compare the PK, efficacy, safety and immunogenicity of MB12 versus Keytruda® in combination with pemetrexed-platinum chemotherapy as first-line treatment in patients with metastatic nsNSCLC. The study commenced in December 2024 and is currently recruiting, with estimated primary completion in June 2026.

(e) Sandoz (GME751): Ph 1 study commenced in May 2024 to compare PK of GME751 and Keytruda® in patients with stage II and III melanoma requiring adjuvant treatment with pembrolizumab. The study is currently recruiting with estimated primary completion in July 2026.  In April 2025, Sandoz announced it has “minimised” its Ph 3 trial in untreated metastatic nsNSCLC due to streamlining of FDA study requirements.

(f) Celltrion (CT-P51): Ph 3 trial plan approved by FDA in August 2024 with study initiated in January 2025 to compare efficacy and safety of CT-P51 and Keytruda® in combination with platinum pemetrexed chemotherapy in patients with previously untreated metastatic nsNSCLC. The study is currently recruiting with estimated primary completion in February 2027.

(g) Shanghai Henlius (HLX17): Integrated Ph 1/3 study initiated in April 2025 to evaluate the efficacy, safety, PK profile and immunogenicity of HLX17 vs Keytruda® in the first-line treatment of advanced nsNSCLC. The study is not yet recruiting, with estimated primary completion in April 2027.

(h) Bio-Thera (BAT3306): Ph 1/3 study commenced in July 2024 to evaluate the PK, efficacy and safety of BAT3306 plus chemotherapy versus Keytruda® plus chemotherapy in patients with stage IV nsNSCLC. The study is currently recruiting with estimated primary completion in July 2027.

(i) BioNTech (BNT327): Phase 2/3, Master Protocol for a Global Trial of BNT327 in combination with chemotherapy and other investigational agents in first-line NSCLC, initiated in January 2025. The study is currently recruiting, with estimated primary completion in December 2029.

July 18, 2025

On 18 July 2025, the Delhi High Court issued a preliminary injunction restraining Zydus Lifesciences from launching its nivolumab biosimilar (ZRCr-4276) in India.  The injunction was granted in proceedings brought by BMS alleging Zydus’ Indian launch of its nivolumab biosimilar will infringe Indian patent no. 340060 (IN ’060).

The Court found that IN ‘060, which expires on 2 May 2026, covers BMS’ Opdivo® (nivolumab), sold as Opdyta® in India.  The Court also held that the patent’s validity was not sufficiently in doubt.  IN ‘060 had survived four pre-grant oppositions, filed by Indian Pharmaceutical Alliance (IPA), Pankaj Kumar Singh, Restech Pharmaceuticals and Dr. Reddy’s.  In addition, the validity of corresponding foreign patents had been upheld.  While IN ‘060 was currently facing a post-grant opposition filed by Zydus, that opposition had not yet been finalised.

As well as preventing launch before the patent’s expiry, the preliminary injunction prohibits the post-expiry sale of ZRCr-4276 manufactured before that expiry date.  Under Indian law, infringing goods manufactured during the term of a patent remain infringing after the patent expires.  Zydus has therefore been ordered to file an affidavit disclosing the quantity of biosimilar nivolumab it has already manufactured.

Zydus received regulatory approval for its nivolumab biosimilar from India’s CDSCO in July 2024.  At least Amgen, Sandoz and Xbrane/Intas also have nivolumab biosimilars under development.

Zydus is no stranger to patent infringement proceedings in India, having faced patent infringement litigation brought by Roche in relation to its pertuzumab biosimilar.

July 18, 2025

In an article dated 18 July 2025, HiT News reported on a hearing in a patent infringement lawsuit filed by Regeneron and Bayer against Sam Chun Dang (SCD) and Optus Pharmaceutical in the Seoul Central District Court.  The lawsuit was filed by Regeneron/Bayer in January 2024 alleging that SCD’s licence agreement with an unnamed overseas company to supply its Eylea® (aflibercept, 2mg) biosimilar (SCD411) constituted infringement of Regeneron’s Korean Patent No. 659477.  Regeneron/Bayer are seeking damages based on the alleged infringement.

According to the article, at the hearing on 17 July 2025, the Court refused Regeneron/Bayer’s request for an order that SCD submit various documents and information, including the details of the licence agreement and other internal documents relating to that agreement.  SCD had objected to producing the documents on the basis that they were confidential and all contracts it entered in relation to biosimilar aflibercept were to take effect after expiry of the Korean patent.

The Court has reportedly narrowed the issues in dispute in the lawsuit to whether SCD’s entry into licence agreements before the expiry of the Korean patent constitutes patent infringement.  A further hearing has been scheduled for 11 September 2025.

In March 2024, it was reported that Sam Chun Dang had entered an exclusive distribution agreement with an unnamed distributor to supply its aflibercept biosimilar in the UK, Belgium, the Netherlands, Norway, Portugal, Sweden, Greece, Ireland and Finland.  SCD’s biosimilar was also the subject of an exclusive distribution agreement reported in November 2023 with an unnamed distributor, for supply to Austria, Germany, Italy, Spain and Switzerland.  SCD reportedly licensed SCD411 to Apotex for the Canadian market in August 2023.

July 17, 2025

On 17 July 2025, Samsung Bioepis announced that it has entered into a licence, development and commercialisation agreement with eyecare pharmaceutical company, Harrow, in relation to Samsung Bioepis’ US ophthalmology portfolio.  The agreement follows Biogen’s October 2024 decision to terminate its November 2019 agreement with Samsung Bioepis, within the US and Canada, for commercialisation of Samsung Bioepis’ ophthalmology biosimilars.

Under the new agreement, Harrow will assume full commercial responsibility in the US for Samsung Bioepis’ Byooviz® (ranibizumab-nuna), biosimilar to Genentech’s Lucentis®, and Opuviz® (aflibercept-yszy), biosimilar to Regeneron’s Eylea®, upon full transition of Biogen’s commercialisation rights back to Samsung Bioepis by the end of 2025.

Opuviz® was the first FDA approved interchangeable aflibercept biosimilar (with Biocon’s Yesafili™) in May 2024.  The US launch date for the product remains uncertain due to ongoing patent litigation brought by Regeneron against Samsung Bioepis (amongst others) regarding aflibercept.  A preliminary injunction was granted, and remains in place, preventing Opuviz®’s US launch (14 June 2024, upheld on appeal on 29 January 2025).

Byooviz® was FDA approved in September 2021, launched in the US on 2 June 2022 and approved as interchangeable to Lucentis® across all approved indications in October 2023.

July 16, 2025

On 16 July 2025, Celltrion announced the results of its global phase 3 trial comparing the efficacy and safety of its tocilizumab biosimilar, Avtozma® (CT-P47), to reference drug, Roche’s Actemra®.  The results demonstrated comparable efficacy, pharmacokinetics, safety and immunogenicity between patient groups that maintained the reference product and those that switched to Avtozma®.

Celltrion launched Avtozma® in Korea in June 2025, following its approval in December 2024 for the same indications as Actemra®.  Just days earlier, Australia’s Therapeutic Good’s Administration (TGA) approved Avtozma® as the first tocilizumab biosimilar in the country.

In February 2025, Avtozma® became the third tocilizumab biosimilar approved in the EU, following Fresenius Kabi’s Tyenne®, in both IV and SC forms, in November 2023, and Biogen’s IV Tofidence™, in June 2024Avtozma® was also the third tocilizumab biosimilar approved in the US in January 2025, trailing Fresenius Kabi’s Tyenne® (tocilizumab-aazg) (SC formulation, March 2024) and Biogen/Bio-Thera’s Tofidence®/BAT1806 (tocilizumab-bavi) (IV formulation, September 2023).

July 16, 2025

On 16 July 2025, Bio-Thera Solutions announced that the FDA has accepted for review its Biological Licence Application (BLA) for BAT2506, biosimilar to J&J’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.

The BAT2506 BLA is the second BLA for a golimumab biosimilar to be accepted by the FDA, following acceptance of Alvotech/Teva’s BLA for AVT05 in January 2025, approval of which is expected in Q4 2025.

Accord’s BLA for BAT2506 requests approval for all currently approved indications of Simponi®, including the following treatments for adults: moderately to severely active rheumatoid arthritis (RA) (with methotrexate), active psoriatic arthritis (alone or with methotrexate), active ankylosing spondylitis and moderately to severely active ulcerative colitis.

Bio-Thera has entered commercialisation agreements for BAT2506 in jurisdictions outside the US, 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).  In November 2024, Alvotech/Advanz Pharma’s European marketing authorisation application for AVT05 was the first golimumab biosimilar MAA to be accepted anywhere in the world.

July 15, 2025

On 15 July 2025, Biocon Biologics announced that the FDA has approved Kirsty™ (insulin aspart-xjhz) as the first and only interchangeable biosimilar to Novo Nordisk’s NovoLog®.

Kirsty™ (100 units/mL) will be available as a single-patient-use prefilled pen for subcutaneous use and a multiple dose vial for subcutaneous and intravenous use.  It is indicated to improve glycaemic control in adults and paediatric patients with diabetes mellitus.  Kirsty™ has been available in Europe and Canada since 2022.

In February 2025, Sanofi-Aventis’ Merilog™/Merilog™ SoloStar were approved as the first US biosimilars to NovoLog®.  However, those products have not been granted interchangeability status.  There were also two long-acting insulin biosimilar products (insulin glargine) approved in 2021, Biocon/Mylan’s Semglee® and Eli Lilly’s Rezvoglar® (reference product: Sanofi’s Lantus®).

July 14, 2025

On 14 July 2025, Samsung Bioepis published a whitepaper entitled “Solving the Biosimilar Void in Europe”, which proposes various recommendations for European biosimilar policy reform.

The whitepaper states that the current biosimilar policy environment in Europe needs “improvements to better reflect the value recognition of biosimilars and ultimately support a more sustainable market”.  In particular, it identifies challenges that biosimilars face, with “restrictive and misaligned tailored Health Technology Assessment (HTA) and pricing and reimbursement (P&R) processes”; “tendering and cost-containment policies that lead to continuous price erosion” throughout the lifecycle of biosimilars; and polices that hinder sufficient uptake of biosimilars.

Against this background, Samsung Bioepis’ policy recommendations include the following:

  • Tailoring and streamlining HTA for biosimilars (eg. taking into account additional benefits of biosimilars, HTA waivers, indication extrapolation and mechanisms for acceleration);
  • Avoiding arbitrary price controls for biosimilars at launch (eg. unjustified mandatory discounts) and allowing price discounts to be achieved by market dynamics;
  • Ensuring national, regional and local tenders support diversification of supply and fair competition through multi-winner tenders with contract volume shares; transparent and periodic tender opening and a broad set of value criteria considerations; and
  • Implementing incentives to healthcare professionals to encourage prescribing and dispensing of biosimilars, based on shared decision making between physicians and patients

The whitepaper considers that “the most important step” is for “policymakers to shift from perceiving biosimilars solely as cost saving tools” and to recognise their “vital role in strengthening market efficiency, patient access and system resilience”.

July 11, 2025

On 11 July 2025, Ono Pharma announced that Korea’s Ministry of Food and Drug Safety has approved an indication extension for Opdivo® (nivolumab) in combination with Yervoy® (ipilimumab) for first-line IV treatment of patients with unresectable or metastatic hepatocellular carcinoma.

The combination therapy has previously been approved for HCC in other jurisdictions including Japan (June 2025), the US (April 2025), and the EU (March 2025).

At least Amgen, Sandoz and Xbrane/Intas have nivolumab biosimilars under development.  In April 2025, Sandoz and Shanghai Henlius Biotech announced a global collaboration agreement for a biosimilar to BMS’ Yervoy® (ipilimumab).

July 10, 2025

On 10 July 2025, Formycon announced that it has completed patient enrolment for its clinical study, “Dahlia”, which is comparing the pharmacokinetics, safety and tolerability of FYB206 (pembrolizumab) with MSD’s Keytruda® in malignant melanoma.  The study was commenced in June 2024 and has now enrolled a total of 96 participants.

Formycon had originally intended to conduct a parallel Phase 3 trial (“Lotus”) to compare the safety and efficacy of FYB206 with Keytruda® in non-small cell lung cancer (NSCLC).  However, in February 2025, Formycon announced the premature termination of the Phase 3 trial following communications with the US FDA and concluding that the trial was not necessary to obtain US approval of FYB206.

Formycon expects results of the study to be available in Q1 2026, with the earliest market entry of FYB206 being in 2029 for the US and after 2030 for the EU.

There are a number of other pembrolizumab biosimilars in clinical trials, including Celltrion’s CT-P51 (Ph 3 trial plan approved by FDA in August 2024), Bio-Thera’s BAT3306 (Ph 1/3 in nsNSCLC commenced in July 2024), Amgen’s ABP 234 (Ph 3 in nsNSCLC initiated May 2024), Samsung Bioepis’ SB27 (Ph 3 in metastatic nsNSCLC commenced April 2024) and Sandoz’s GME751 (Ph 1 commenced in May 2024).

In September 2024, Shanghai Henlius Biotech received approval in China for a clinical trial of its pembrolizumab biosimilar, HLX17 and, in June 2025, Alvotech and Dr Reddy’s announced that they entered into a global collaboration and licence agreement to co-develop, manufacture and commercialise a pembrolizumab biosimilar.

BioBlast® extract From July 10, 2025 to July 21, 2025

BioBlast® Editor and Contributing Author

Naomi Pearce & Emily Bristow

Naomi Pearce & Emily Bristow

Editor: Naomi Pearce, Executive Lawyer, Patent Attorney & Trade Mark Attorney
Contributing Author: Emily Bristow, Law Graduate

Get our Pearce IP Blogs & BioBlast® sent directly to your inbox

Subscribe to our Pearce IP Blogs and BioBlast® to receive our updates via email.