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Biosimilars Deals 2021

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.

Regeneron Fails to Injunct Amgen’s US Aflibercept Biosimilar for Second Time; Amgen to Launch At Risk

Oct 22, 2024

On 22 October 2024, the United States Court of Appeals for the Federal Circuit ruled that Regeneron was not entitled to an injunction preventing Amgen from launching its aflibercept biosimilar pending appeal. That appeal concerns a September 2024 decision of the US District Court for the Northern District of West Virginia denying Regeneron’s motion for a preliminary injunction against Amgen.

However, the Appeals Court has agreed to expedite the appeal proceeding, with the hearing set for January 2025.

Following the decision of the Appeals Court, media reports reveal that Amgen intends to launch its US aflibercept biosimilar, Pavblu™, “as quickly as possible”. Pavblu™, biosimilar to Regeneron’s Eylea® was approved by the FDA in August 2024 for nAMD, macular oedema following RVO, diabetic macular oedema and diabetic retinopathy.

The proceedings brought by Regeneron against Amgen are part of consolidated, multi-district BPCIA litigation brought by Regeneron regarding aflibercept biosimilars against each of Samsung Bioepis (2 actions; Opuviz™/SB15 approved May 2024), Biocon (Yesafili™ approved May 2024), Formycon (Ahzantive®/FYB203 approved June 2024), Celltrion (2 actions; aBLA for CT-P42 submitted to FDA in June 2023) and Sandoz (Enzeevu™ approved August 2024).

The US District Court’s refusal to grant a preliminary injunction against Amgen differs from decisions of the same Court to grant preliminary injunctions against Samsung Bioepis (14 June 2024), Formycon (21 June 2024) and Celltrion (June-July 2024), and a permanent injunction against Biocon (11 June 2024), based on findings of infringement of Regeneron’s US patent 11,084,865 (ophthalmic formulations of a VEGF antagonist).

Samsung Bioepis, Formycon and Celltrion lodged appeals from the preliminary injunction orders (on 14 June 2024, 25 June 2024, and 10 July 2024, respectively). Biocon filed a Notice of Appeal from the permanent injunction order on 21 June 2024. Those appeals are all pending.

Novo Nordisk Nominates Semaglutide for Inclusion in FDA’s DDC List

Oct 22, 2024

On 22 October 2024, the US Food and Drug Administration (FDA) posted notices detailing Novo Nordisk’s request to include semaglutide in the FDA’s Demonstrable Difficulties for Compounding (DDC) list. The request aims to prevent compounding pharmacies from producing copied versions of Ozempic® (marketed for type 2 diabetes) and Wegovy® (for weight management), both of which comprise semaglutide.

Novo Nordisk argues that semaglutide is challenging to produce safely due to its complex formulation involving yeast-based recombinant DNA technology. Furthermore, compounded versions lack clinical testing, exhibit different impurity profiles, and have raised safety concerns. This is consistent with alerts issued by the FDA to US healthcare providers in July 2024 in relation to risks associated with compounded semaglutide, and the position taken by the Australian Therapeutic Goods Administration (TGA) which has banned compounded copies of Ozempic® since 1 October 2024 due to serious safety concerns.

Competitor Eli Lilly is similarly pushing back against compounded versions of its weight-loss drug Mounjaro® (tirzepatide), filing lawsuits against retailers Pivotal Peptides, MangoRx and Genesis Lifestyle Medicine of Nevada for selling unauthorised compounded formulations. Notably, compounded tirzepatide is also banned in Australia as of 1 October 2024.

Alvotech/Teva’s Biosimilar Ustekinumab – Second Presentation FDA Approved

Oct 22, 2024

On 22 October 2024, Alvotech and Teva announced US FDA approval of an additional presentation of Selarsdi™ (ustekinumab), biosimilar to Janssen’s Stelara®. The additional presentation covers Selarsdi™ 130 mg/26 ml in a single-dose vial for intravenous infusion and expands the label to include treatment of adults with Crohn’s disease and ulcerative colitis.

This announcement follows the FDA’s previous approval in April 2024 for Selarsdi™ 45 mg/0.5 mL and 90 mg/mL in a single-dose prefilled syringe for subcutaneous injection, for both adult and paediatric use.

Selarsdi™ was developed by Alvotech and will be commercialised by Teva in the United States, pursuant to an August 2020 strategic partnership between the companies for the exclusive commercialisation of five of Alvotech’s biosimilar product candidates, including Selarsdi™. The partnership was expanded in July 2023 to include additional products.

Selarsdi™ can be launched in the US from 21 February 2025, following Alvotech’s and Teva’s ustekinumab settlement with Johnson & Johnson in June 2023 and the parties have confirmed that US launch for all indications is expected in Q1/2025.

Pearce IP BioBlast® for the week ending 18 October 2024

Oct 21, 2024

Aflibercept

18 October 2024 | Regeneron Announces 3-Year Results for High Dose Eylea® (Aflibercept)

On 18 October 2024, Regeneron announced positive three year results for Eylea HD® (aflibercept, 8 mg injection) from an extension study of the Phase 3 PHOTON trial in patients… Read more here.

Bimekizumab

14 October 2024 | US | FDA Approves UCB’s 320mg Single-Injection Device Presentations of Bimzelx® (Bimekizumab)

On 14 October 2024, UCB announced that the US FDA has approved a 2 mL pre-filled syringe and pre-filled autoinjector, each containing 320 mg of Bimzelx® (bimekizumab-bkzx)… Read more here.

Catumaxomab, Concizumab

17 October 2024 | EU | CHMP Delivers Good News for Novo Nordisk, Lindis, Sanofi and BeiGene

At its October 2024 meeting, the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) recommended granting marketing authorisation for… Read more here.

Daratumumab

15 October 2024 | J&J Reports Q3 2024 Results as Sales of Darzalex® Reach USD $3B

On 15 August 2024, Johnson & Johnson (J&J) reported its results for Q3 2024, which saw sales growth of 5.2% to $22.5B. J&J’s significant regulatory announcements this… Read more here.

Lecanemab

16 October 2024 | AU | ‘Blow’ to Australia’s Alzheimer’s Patients – TGA Rejects Eisai’s Leqembi® (Lecanemab) Due To Safety & Efficacy Concerns

On 16 October 2024, Australia’s Therapeutic Goods Administration (TGA) reported its decision not to register Leqembi® (lecanemab) for the treatment of patients with… Read more here.

Marstacimab

11 October 2024 | US | Approval Alert: US Approval of Pfizer’s Hympavzi™ (Marstacimab) for Haemophilia

On 11 October 2024, Pfizer announced that the US FDA has approved its Hympavzi™ (marstacimab-hncq) for the treatment of adults and adolescents with haemophilia A or B… Read more here.

Nivolumab

9 October 2024 | TW | Ono’s Opdivo® Combination Therapy Approved in Taiwan for Urothelial Carcinoma
On 9 October 2024, Ono Pharma Taiwan received additional approval of Opdivo® (nivolumab) intravenous infusion in combination with cisplatin and gemcitabine, from the… Read more here.

Nivolumab, Pembrolizumab

18 October 2024 | AU | PBAC Guidance Means Broad, Multi-Cancer Funding Agreements for PD-(L)1 Inhibitors Unlikely in AU

On 18 October 2024, Australia’s Pharmaceutical Benefits Advisory Committee (PBAC), published the outcomes of its September 2024 intracycle meeting. This included… Read more here.

Pembrolizumab

16 October 2024 | Formycon’s Pembrolizumab Biosimilar Demonstrates Keytruda® Similarity

On 16 October 2024, Formycon announced that results of a comparative analytical evaluation of its FYB206, published in Drugs in R&D, showed FYB206 to be structurally… Read more here.

8 October 2024 | UK | Keytruda®/Padcev® Combination Therapy for Bladder Cancer Approved in UK

On 8 October 2024, MSD’s Keytruda® (pembrolizumab) and Astellas/Pfizer’s Padcev® (enfortumab vedotin) were approved by the Medicines and Healthcare products Regulatory… Read more here.

Pertuzumab

16 October 2024 | IN | Delhi High Court Reinstates Injunction Against Zydus’ Pertuzumab Biosimilar

On 16 October 2024, the Economic Times reported that the Delhi High Court has reinstated an injunction preventing Zydus from manufacturing, selling or marketing… Read more here.

Semaglutide, Insulin degludec, Insulin aspart

16 October 2024 | Gan & Lee Pharmaceuticals Enters the GLP-1 Agonist Weight Loss Market with Ozempic® Competitor GZR18

On 16 October 2024, Chinese insulin maker Gan & Lee Pharmaceuticals reported its development of an injectable GLP-1 agonist, GZR18, which it claims has outperformed… Read more here.

Tocilizumab

17 October 2024 | CA | Fresenius Kabi Launches First Tocilizumab Biosimilar in Canada

On 17 October 2024, Fresenius Kabi announced its Canadian launch of Tyenne®, biosimilar to Roche’s Actemra® (tocilizumab), in both IV and subcutaneous formulations… Read more here.

Trastuzumab deruxtecan

14 October 2024 | CN | AstraZeneca/Daiichi’s Enhertu® Receives Conditional Approval in China

On 14 October 2024, AstraZeneca, in partnership with Daiichi Sankyo, announced that Enhertu® (trastuzumab deruxtecan) has received conditional approval in China… Read more here.

Ustekinumab

17 October 2024 | EU | CHMP Adopts Positive Opinions for Accord Ustekinumab Biosimilars

At its October meeting, the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) adopted positive opinions for Accord… Read more here.

Zolbetuximab

18 October 2024 | US | Approval Alert: FDA Approves Astellas Pharma’s Zolbetuximab

On 18 October 2024, Astellas Pharma announced that the FDA has approved Vyloy^TM (zolbetuximab-clzb) in combination with fluoropyrimidine- and platinum-containing… Read more here.

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Pearce IP is a boutique firm offering intellectual property specialist lawyers, patent attorneys and trade mark attorneys to the life sciences industries (in particular, pharmaceutical, biopharmaceutical, biotech, ag-tech and food tech). Pearce IP is the 2021 ‘Intellectual Property Team of the Year’ (Lawyers Weekly Australian Law Awards) and was shortlisted for the same award in 2022. Pearce IP is ranked in IAM Patent 1000 and Managing IP (MIP) IP Stars, in Australasian Lawyer 5 Star Awards as a ‘5 Star’ firm, and the Legal 500 APAC Guide for Intellectual Property.

Our leaders have been recognised in virtually every notable IP listing for their legal, patent and trade mark excellence including: IAM Patent 1000, IAM Strategy 300, MIP IP Stars, Doyles Guide, WIPR Leaders, 5 Star IP Lawyers, Best Lawyers, and Australasian Lawyer 5 Star Awards, and have been honoured with many awards including Australian Law Awards – IP Partner of the Year, Women in Law Awards – Partner of the Year, Women in Business Law Awards - Patent Lawyer of the Year (Asia Pacific), Most Influential Lawyers (Changemaker), among other awards.

Naomi Pearce

CEO, Executive Lawyer (AU, NZ), Patent & Trade Mark Attorney (AU, NZ)

Naomi is the founder of Pearce IP, and is one of Australia’s leading IP practitioners. Naomi is a market leading, strategic, commercially astute, patent lawyer, patent attorney and trade mark attorney, with over 25 years’ experience, and a background in molecular biology/biochemistry. Ranked in virtually every notable legal directory, highly regarded by peers and clients, with a background in molecular biology, Naomi is renown for her successful and elegant IP/legal strategies.

Among other awards, Naomi is ranked in Chambers, IAM Patent 1000, IAM Strategy 300, is a MIP “Patent Star”, and is recognised as a WIPR Leader for patents and trade marks. Naomi is the 2023 Lawyers Weekly “IP Partner of the Year”, the 2022 Lexology client choice award recipient for Life Sciences, the 2022 Asia Pacific Women in Business Law “Patent Lawyer of the Year” and the 2021 Lawyers Weekly Women in Law SME “Partner of the Year”. Naomi is the founder of Pearce IP, which commenced in 2017 and won 2021 “IP Team of the Year” at the Australian Law Awards.

Chantal Savage

Special Counsel, Lawyer

Chantal is an intellectual property disputes lawyer with experience advising across the spectrum of IP rights, including patents, trade marks, copyright, plant breeder’s rights and trade secrets/confidential information. Recognised as a Rising Star in IP by the Legal 500 Asia Pacific (2021-2024), Chantal has previously worked for international and top tier law firms in Australia and the United Kingdom and now at Pearce IP.

With a science degree specialising in molecular biology and biochemistry, Chantal’s practice focuses particularly on complex, high-value, multi-jurisdictional patent infringement and revocation proceedings for clients in the life sciences sectors.

Nathan Kan

Graduate (Law)

Nathan is a Graduate (Law) focused on providing legal services and advice to life sciences clients, with a focus on litigation support regarding intellectual property (patents, trade marks, designs, copyright, domain names, plant breeders rights and confidential information) and commercial disputes.

Nathan is passionate about the intersection of law and science. Whilst serving as Sponsorship Director and subsequently as Vice President of the Science and Technology Law Association (SATLA) at the University of Melbourne, he led various engagement events, workshops and publications covering a range of STEM fields, including life sciences, artificial intelligence and digital transformation.

Update on Xbrane Out-Licensing Nivolumab & Certolizumab Biosimilars

Oct 21, 2024

In August 2024, Xbrane commenced its out-licensing process for Xdivane™, biosimilar to BMS’ Opdivo® (nivolumab), and XB003 (previously known as Xcimzane™, BIIB801), biosimilar to UCB’s Cimzia® (certolizumab pegol).

On 21 October 2024, Xbrane announced it reached agreement negotiation stage with Xdivane™ and received the first non-binding proposals on XB003. The previous expectation of concluding an agreement by the end of October 2024 has not been met. This has been extended to the end of November 2024 when a final agreement and an expected upfront payment are needed to fulfil the company’s working capital requirements.

Xbrane reports that its Xdivane™ out-licensing process will enable a launch upon Loss of Exclusivity for BMS’ Opdivo® in the USA in December 2028. Opdivo® achieved sales of approximately USD $8 billion globally during 2023. Xbrane reports its scale-up of the drug substance production process is completed to commercial scale, analytical similarity to the reference product demonstrated and scientific advice on a streamlined clinical development plan has now been received from both EMA and FDA.

Xbrane also reports it has received the first non-binding proposals on XB003. Xbrane says it has successfully scaled up the production process to clinical scale, analytical similarity to the reference product has been demonstrated and scientific advice with EMA and FDA on the clinical development plan is expected in Q1 2025. Again, the previous expectation of a licence agreement being concluded by the end of October 2024 has not been met.

Novo Nordisk Positive Results from Semaglutide Cardiovascular Outcomes Trial

Oct 21, 2024

On 21 October 2024, Novo Nordisk announced positive results from the SOUL cardiovascular outcomes trial, which evaluated the impact of Rybelsus® (oral semaglutide) on major adverse cardiovascular events (MACE) in individuals with type 2 diabetes and established cardiovascular disease (CVD) or chronic kidney disease (CKD).

The trial enrolled 9,650 participants and showed a 14% reduction in MACE among those receiving oral semaglutide compared to a placebo, both alongside standard care. The primary endpoint included cardiovascular death, non-fatal heart attacks, and non-fatal strokes, with all components contributing to the significant benefit observed. Nearly half of the participants also received sodium-glucose co-transporter 2 (SGLT2) inhibitors at some point during the trial as a part of standard care.

The SOUL trial has shown oral semaglutide to be well-tolerated and safe. According to a company media release, Novo Nordisk plans to seek regulatory approval for expanding the label of Rybelsus® in the US and EU by early 2025 as a result of the positive trial results.

Approval Alert: Samsung Bioepis Ustekinumab Biosimilar Approved in Australia

Oct 21, 2024

On 21 October 2024, the Australian TGA approved three presentations of Samsung Bioepis’ Epyztek®, biosimilar to Janssen’s Stelara® (ustekinumab): 90 mg/1 mL solution for injection pre-filled syringe, 45 mg/0.5 mL solution for injection pre-filled syringe and 5 mg/1 mL solution for intravenous infusion injection vial.

The Epyztek® registrations closely follow approvals for two new presentations of Janssen’s second ustekinumab brand, Setrelvo® on 18 October 2024: 90 mg/1 mL solution for injection pre-filled pen (One-Press patient-controlled injector) and 45 mg/0.5 mL solution for injection pre-filled pen (One-Press patient-controlled injector). Setrelvo® was first approved in Australia in July 2024.

Epyztek® is the fourth ustekinumab biosimilar to be approved in Australia, following Celltrion’s SteQeyma®/CT-P43 (September 2024) and Amgen’s Wezlana® (January 2024) and Ajemnye® (May 2024). Australia’s PBAC recommended Wezlana® for PBS listing at its March 2024 meeting.

Samsung Bioepis and Janssen are currently embroiled in two patent infringement and invalidity proceedings in the Federal Court of Australia in respect of patents regarding the use of ustekinumab for the treatment of ulcerative colitis (UC). The first proceeding is expected to be discontinued soon following the surrender of the two innovations patents in suit and the resolution of an outstanding costs issue. The second proceeding has been set down for a 9-day final hearing commencing 2 June 2025.

In the UK, Samsung Bioepis successfully revoked Janssen’s Stelara® UC patent in the High Court of Justice of England and Wales in July 2024. In that case, Mr Justice Meade held that European Patent No EP 3883606 is invalid for obviousness in light of a slide presentation entitled “Safety and efficacy of Ustekinumab Induction Therapy in Patients with Moderate to Severe UC: Results from the Phase 3 UNIFI Study” delivered at the October 2018 American College of Gastroenterology conference. On 26 September 2024, Janssen was refused leave to appeal.

Regeneron Announces 3-Year Results for High Dose Eylea® (Aflibercept)

Oct 18, 2024

On 18 October 2024, Regeneron announced positive three year results for Eylea HD® (aflibercept, 8 mg injection) from an extension study of the Phase 3 PHOTON trial in patients with diabetic macular oedema (DME). The results were presented at the American Academy of Ophthalmology (AAO) Annual Meeting.

The data reportedly demonstrates that the vast majority of Eylea HD® patients who entered the extension study sustained the visual gains and anatomic improvements achieved by the end of the second year and achieved longer treatment intervals. Patients who switched to Eylea HD® reportedly experienced slower fluid re-accumulation following their first dose. According to Regeneron, the longer dosing intervals and slower fluid re-accumulation supports the longer duration of action of Eylea HD®.

Eylea® 8mg was jointly developed by Bayer and Regeneron. Regeneron holds the exclusive rights to both low and high dose Eylea® in the US, while Bayer holds those outside the US, where the companies equally share the profits from sales of the products.

High dose Eylea® for intravitreal injection has previously been approved for nAMD and DME in Australia (June 2024), the EU (January 2024), Japan (January 2024), and the UK (January 2024). Eylea HD® was approved for nAMD, DME and diabetic retinopathy in the US (August 2023).

More recently, high dose Eylea® pre-filled syringe (OcuClick) was approved in Australia (October 2024) and Europe (September 2024).

PBAC Guidance Means Broad, Multi-Cancer Funding Agreements for PD-(L)1 Inhibitors Unlikely in AU

Oct 18, 2024

On 18 October 2024, Australia’s Pharmaceutical Benefits Advisory Committee (PBAC) published the outcomes of its September 2024 intracycle meeting. This included consideration of proposals for broad Pharmaceutical Benefits Scheme (PBS) listings for PD-(L)1 inhibitors, including MSD’s pembrolizumab and BMS’ nivolumab, to allow expanded access to all current and future indications registered by the Therapeutic Goods Administration (TGA) without review of the clinical- and cost-effectiveness of each indication. Consideration of these proposals had been deferred from the PBAC’s December 2023 meeting.

The PBAC determined that any broad subsidy proposal would need to address a list of parameters, including: “the potential risk of causing harm either directly (forgoing effective current standard treatments, adverse events) or intangibly (false hope, not resolving patient needs, inadequate provision of palliative care)”; the high level of uncertainty in cost-effectiveness when a PD-(L)1 inhibitor is not assessed for a specific listing based on clinical trial data for that use; the potential impact on other medicines (including PD-(L)1 inhibitors) that may already be in the market; and “biosimilar policies that might be in place, noting that multiple biosimilars for pembrolizumab and nivolumab are in the late phase of clinical development, with patents due to expire in some jurisdictions within the next five years”. PBAC noted that, to date, it had not received an acceptable proposal for an expanded listing to facilitate broad access to PD-(L)1 inhibitors.

However, the PBAC said it is “supportive of implementing simplified listings for PD-(L)1 inhibitors within a specific tumour type if this would facilitate appropriate and timely access for patients”. It is encouraging sponsors to make submissions for simplified PBS listings within tumour types “via the standard process”.

PD-(L)1 inhibitors currently listed on the PBS include MSD’s Keytruda® (pembrolizumab), BMS’ Opdivo® (nivolumab), AstraZeneca’s Imfinzi® (durvalumab), Merck Healthcare’s Bavencio® (avelumab), Medison Pharma Australia’s Libtayo® (cemiplimab) and GSK’s Jemperli® (dostarlimab). BeiGene’s Tevimbra® (tislelizumab) and AA-Med’s toripalimab are under evaluation by the TGA.

Approval Alert: FDA Approves Astellas Pharma’s Zolbetuximab

Oct 18, 2024

On 18 October 2024, Astellas Pharma announced that the FDA has approved Vyloy™ (zolbetuximab-clzb) in combination with fluoropyrimidine- and platinum-containing chemotherapy for the first-line treatment of adult patients with locally advanced unresectable or metastatic human epidermal growth factor receptor 2 (HER2)-negative gastric or gastroesophageal junction (GEJ) adenocarcinoma whose tumours are claudin (CLDN) 18.2 positive. Vyloy™ is the first CLDN18.2-targeted therapy approved in the U.S.

The US approval follows September 2024 approvals for the same Vyloy™ combination in Europe and Korea. Vyloy™ has previously been approved in the UK (August 2024), Japan (March 2024) and China (August 2023).

CHMP Delivers Good News for Novo Nordisk, Lindis, Sanofi and BeiGene

Oct 17, 2024

At its October 2024 meeting, the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) recommended granting marketing authorisation for Novo Nordisk’s Alhemo® (concizumab) for routine prophylaxis of bleeding in patients of 12 years of age or more with haemophilia A (with FVIII inhibitors) or haemophilia B (with FIX inhibitors), and Lindis Biotech’s Korjuny® (catumaxomab) for malignant ascites.

The committee also recommended extensions of indications for Sanofi’s Kevzara® (sarilumab) for the treatment of polymyalgia rheumatica (PMR) in adult patients who have had an inadequate response to corticosteroids or who experience a relapse during corticosteroid taper, and BeiGene’s Tevimbra® (tislelizumab) for certain patients with previously untreated oesophageal squamous cell carcinoma (OSCC) and certain patients with gastric or gastroesophageal junction (G/GEJ) adenocarcinoma.

Two ustekinumab biosimilars also received positive opinions at CHMP’s October 2024 meeting, as reported here.

Fresenius Kabi Launches First Tocilizumab Biosimilar in Canada

Oct 17, 2024

On 17 October 2024, Fresenius Kabi announced its Canadian launch of Tyenne®, biosimilar to Roche’s Actemra® (tocilizumab), in both IV and subcutaneous formulations. Tyenne® is indicated for the treatment of several inflammatory and immune diseases, including rheumatoid arthritis, giant cell arteritis, polyarticular juvenile idiopathic arthritis, and systemic juvenile idiopathic arthritis. It is the first and only tocilizumab biosimilar to be launched to date in Canada.

Fresenius Kabi launched Tyenne® in Europe as the first to market biosimilar in November 2023 in both IV and subcutaneous formulations. Tyenne® was launched in the US in an IV formulation in April 2024 and in a subcutaneous formulation in July 2024.

CHMP Adopts Positive Opinions for Accord Ustekinumab Biosimilars

Oct 17, 2024

At its October meeting, the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) adopted positive opinions for Accord HealthCare’s, Imuldosa® (DMB-3115) and Absimky® (DMB-3115), biosimilars to Janssen’s Stelara® (ustekinumab). Both biosimilars are indicated for plaque psoriasis, paediatric plaque psoriasis, psoriatic arthritis (PsA) and Crohn’s disease, with Absimky® additionally being indicated for ulcerative colitis.

In July 2021, Dong-A ST and Meiji Seika Pharma entered into an exclusive global licence agreement with Intas Pharmaceuticals, under which Intas received worldwide commercialisation rights for DMB-3115, excluding Korea, Japan and certain other Asian countries. Intas is commercialising DMB-3115 via its subsidiaries, Accord Healthcare in the EU, UK and Canada, and Accord Biopharma in the US.

Earlier this month, Imuldosa® was approved by the FDA as the fifth approved ustekinumab biosimilar in the US. Accord Biopharma reached a settlement with Janssen in October 2023, allowing DMB-3115 to launch in the US no later than 15 May 2025.

Previously approved ustekinumab biosimilars in Europe include Formycon/Fresenius’ Otulfi®/FYB202 (September 2024), Samsung Bioepis’ Eksunbi™ (September 2024), Celltrion’s SteQeyma®/CT-P47 (August 2024), Amgen’s Wezenla™ (June 2024), Sandoz/Samsung Bioepis’ Pyzchiva®/SB17 (April 2024, launched July 2024) and Alvotech/Stada’s Uzpruvo® (January 2024, launched July 2024). Bio-Thera’s MAA for BAT2206 (ustekinumab) was accepted by the EMA in July 2024.

‘Blow’ to Australia’s Alzheimer’s Patients – TGA Rejects Eisai’s Leqembi® (Lecanemab) Due To Safety & Efficacy Concerns

Oct 16, 2024

On 16 October 2024, Australia’s Therapeutic Goods Administration (TGA) reported its decision not to register Leqembi® (lecanemab) for the treatment of patients with mild Alzheimer’s dementia (early Alzheimer’s disease) and mild cognitive impairment (MCI) due to Alzheimer’s disease. The decision is based on the TGA’s opinion that demonstrated efficacy did not outweigh the safety risks associated with use of lecanemab. Dementia Australia has issued a media statement calling the decision a ‘blow’ for Australians living with Alzheimer’s disease.

Eisai Australia has advised the TGA that it intends to request reconsideration of the decision.

Leqembi® has previously been approved for MCI and mild dementia due to Alzheimer’s disease in the UK, US, Japan, China, South Korea, Hong Kong and Israel, and the UAE, and applications are under review in the European Union, Brazil, Canada, India, Russia, Taiwan, Singapore, Saudi Arabia and Switzerland.

In a draft guidance issued on 22 August 2024, the UK’s National Institute for Health and Care Excellence (NICE) found that the benefits of lecanemab were too small to warrant making the drug available on the NHS.

Formycon’s Pembrolizumab Biosimilar Demonstrates Keytruda® Similarity

Oct 16, 2024

On 16 October 2024, Formycon announced that results of a comparative analytical evaluation of its FYB206, published in Drugs in R&D, showed FYB206 to be structurally and functionally “highly similar” to MSD’s Keytruda® (pembrolizumab).

FYB206 is currently being evaluated in a phase 1 trial (“Dahlia”) to compare the pharmacokinetics, safety and tolerability of FYB206 with Keytruda® in malignant melanoma (commenced June 2024) and a phase 3 trial (“Lotus”) to compare the efficacy and safety of FYB206 with Keytruda® in combination with chemotherapy in patients with non-small cell lung cancer (NSCLC) (commenced 30 July 2024).

A number of pembrolizumab biosimilars have entered clinical trials this year, 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 25 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 and 3 commenced in April/May 2024). In September 2024, Shanghai Henlius Biotech received approval in China for a clinical trial of its pembrolizumab biosimilar, HLX17.

Delhi High Court Reinstates Injunction Against Zydus’ Pertuzumab Biosimilar

Oct 16, 2024

On 16 October 2024, the Economic Times reported that the Delhi High Court has reinstated an injunction preventing Zydus from manufacturing, selling or marketing Sigrima™, biosimilar to Roche’s Perjeta® (pertuzumab).

The 16 October 2024 decision of the Delhi High Court follows an appeal by Roche of an earlier order of the Court on 9 October 2024, which reversed an injunction order originally granted in July 2024.

The injunction was ordered in proceedings commenced by Roche earlier this year, in which Roche alleges that Zydus’ Sigrima™ infringes Indian patent numbers IN 268632 and IN 464646. Zydus received conditional approval for its pertuzumab biosimilar from the Central Drug Standard Control Organisation (CDSCO) on 4 April 2024, obtained permission to market the drug on 27 June 2024 and subsequently launched Sigrima™ on the Indian market.

On 28 June 2024, Zydus and Dr Reddy’s announced that they had entered a licensing agreement to co-market Zydus’ pertuzumab biosimilar in India as Sigrima™ (Zydus) and Womab® (Dr Reddy’s).

Gan & Lee Pharmaceuticals Enters the GLP-1 Agonist Weight Loss Market with Ozempic® Competitor GZR 18

Oct 16, 2024

On 16 October 2024, Chinese insulin maker Gan & Lee Pharmaceuticals reported its development of an injectable GLP-1 agonist, GZR18, which it claims has outperformed Novo Nordisk’s Ozempic® (semaglutide) in reducing glycated haemoglobin (HbA1c) and body weight in a phase 2 trial for patients with type 2 diabetes. In the 24-week trial involving 264 patients, biweekly doses of GZR18 reportedly led to a greater HbA1c reduction (up to 2.32%) compared to semaglutide (1.60%) and a maximum weight loss of nearly 12 pounds, versus just over seven pounds for semaglutide.

Gan & Lee Pharmaceuticals also announced positive results for two insulin analogues, GZR4 and GZR101, in type 2 diabetes trials, both reportedly outperforming Novo Nordisk’s Tresiba® (insulin degludec) and Ryzodeg® (insulin degludec/insulin aspart), respectively. In patients with poor glycaemic control, once-weekly GZR4 lowered HbA1c by 1.5%, slightly better than degludec’s 1.48%. In another trial, GZR101 lowered HbA1c by 1.56%, which was greater than Ryzodeg’s 1.31%.

J&J Reports Q3 2024 Results as Sales of Darzalex® Reach USD $3B

Oct 15, 2024

On 15 October 2024, Johnson & Johnson (J&J) reported its results for Q3 2024, which saw sales growth of 5.2% to $22.5B. J&J’s significant regulatory announcements this quarter include applications for expanded US and EU indications of Darzalex® (daratumumab) and Darzalex Faspro® (daratumumab and hyaluronidase-fihj) based quadruplet regimens for multiple myeloma (October 2024) and FDA approval for Rybrevant® (amivantamab-vmjw) in combination with standard of care for the treatment non-small cell lung cancer (September 2024).

On the same day, Genmab announced that net sales of Darzalex® (daratumumab) in the third quarter of 2024, as reported by J&J, totalled USD 3,016 million. US sales accounted for more than half of this total, reaching USD 1,684 million. Genmab receives royalties on the worldwide net sales of Darzalex®, both the intravenous and SC products, under its exclusive worldwide license to Janssen to develop, manufacture and commercialise daratumumab.

Pearce IP BioBlast® for the fortnight ending 11 October 2024

Oct 14, 2024

Aflibercept

8 October 2024 | AU | Bayer’s High Dose Eylea® (Aflibercept) PFS Approved in Australia

On 8 October 2024, Australia’s Therapeutic Goods Administration (TGA) approved Bayer’s Eylea® (aflibercept) 8mg pre-filled syringe (PFS), “OcuClick”, for nAMD and diabetic macular oedema (DME)… Read more here.

Cetuximab

10 October 2024 | NZ | Pharmac Broadens Funding for Eli Lilly/Merck KgGA’s Erbitux® (Cetuximab)

New Zealand’s drug-funding body, Pharmac, has announced that Eli Lilly/Merck KgGa’s Erbitux® (cetuximab) will now be funded for left-sided, RAS and BRAF wild-type, metastatic colorectal cancer… Read more here.

Daratumumab

10 October 2024 | US | EU | New Indication Alert: J&J Applies for Expanded US and EU Indications of Darzalex® Quadruplet Regimen for Multiple Myeloma

On 10 October 2024, Johnson & Johnson (J&J) announced that it submitted a Type II variation application to the EMA seeking an indication extension for Darzalex® (daratumumab) subcutaneous formulation in combination with… Read more here.

Denosumab

10 October 2024 | EU | EMA Accepts Alvotech/STADA’s MAA for Biosimilar Denosumab

On 10 October 2024, STADA announced that the European Medicines Agency (EMA) has accepted its marketing authorisation application (MAA) for AVT03, biosimilar to Amgen’s Prolia® and Xgeva® (denosumab)… Read more here.

8 October 2024 | US | EU | Teva’s Biosimilar Denosumab Applications Accepted in US and EU

On 8 October 2024, Teva Pharmaceuticals announced that the US FDA and European Medicines Agency (EMA) accepted Biologics Licence and Marketing Authorisation Applications, respectively, for its TVB-009P… Read more here.

4 October 2024 | US | Amgen Sues Fresenius Kabi in Fourth US BPCIA Action for Infringement of Denosumab Patents

On 4 October 2024, Amgen filed a BPCIA complaint against Fresenius Kabi in the US District Court for the Northern District of Illinois (Eastern Division) asserting infringement of 33 US patents relating to denosumab and methods of its manufacture… Read more here.

Felzartamab

9 October 2024 | US | Biogen Receives FDA Breakthrough Therapy Designation for Felzartamab for Treatment of AMR

On 9 October 2024, Biogen announced that its felzartamab received FDA Breakthrough Therapy Designation (BTD) for the treatment of late antibody-mediated rejection (AMR) without T-cell mediated rejection in kidney transplant patients… Read more here.

LBL-024

9 October 2024 | CN | Nanjing Leads Biolabs Achieves Breakthrough Therapy Designation for LBL-024 in China

On 9 October 2024, Nanjing Leads Biolabs announced that China’s Center for Drug Evaluation of National Medical Products Administration granted Breakthrough Therapy Designation to LBL-024, an anti-PD-L1/4-1BB bispecific antibody… Read more here.

Lecanemab

2 October 2024 | SA | Eisai Submits Application for Leqembi® in Saudi Arabia

On 2 October 2024, Eisai reported that it has submitted an application for approval of Leqembi® (lecanemab) in Saudi Arabia for Alzheimer’s disease… Read more here.

Nivolumab

3 October 2024 | US | New Indication Alert: FDA Approves BMS’ Opdivo® for Perioperative Treatment of Resectable NSCLC with Chemotherapy and Surgery

On 3 October 2024, BMS announced that the FDA has approved Opdivo® (nivolumab) for the treatment of adult patients with resectable non-small cell lung cancer (NSCLC) and no known epidermal growth factor receptor (EGFR) mutations… Read more here.

Pembrolizumab

3 October 2024 | US | Update on MSD Challenges to Johns Hopkins’ Pembrolizumab MOT Patents

On 3 October 2024, the US Patent Trial and Appeal Board (PTAB) instituted inter partes review (IPR) of Johns Hopkins University’s US patent no. 11,643,462 in IPR2024-00648… Read more here.

Pertuzumab

11 October 2024 | IN | Delhi High Court Refuses Interim Injunction Against Zydus’ Pertuzumab Biosimilar

On 9 July 2024, Roche received a temporary injunction order against Zydus from a previous bench of the Delhi High Court, restraining Zydus from marketing or selling their product Sigrima™, biosimilar to Roche’s Perjeta® (pertuzumab), till the next date of hearing… Read more here.

Semaglutide

8 October 2024 | US | Novo Nordisk Settles US Patent Dispute Regarding Semaglutide Patent with Mylan/Natco, Dr Reddy’s, Apotex and Sun Pharma

From 4-8 October 2024, Novo Nordisk and each of Mylan Pharmaceuticals (a subsidiary of Viatris), Dr Reddy’s, Apotex and Sun Pharma filed joint motions notifying the US Patent Trial and Appeal Board (PTAB) that they had settled… Read more here.

30 September 2024 | AU | TGA Issues Warning Following Detection of Counterfeit Semaglutide Products

On 30 September 2024, the Australian Therapeutic Goods Administration (TGA), in collaboration with the Australian Border Force (ABF), issued a notice advising of the detection of counterfeit Ozempic®-labelled pens being imported into Australia… Read more here.

Tocilizumab; Adalimumab

10 October 2024 | US | Samsung Bioepis Publishes Seventh Biosimilar Market Report: Tocilizumab Biosimilars Enter the US Market; Adalimumab Biosimilar US Market Share at 22%

On 10 October 2024, Samsung Bioepis released its quarterly US Biosimilar Market Report. The report has been published every quarter since April 2023 and details average sales price information for US launched biosimilars and market share and price trends.… Read more here.

Trastuzumab

4 October 2024 | JP | Daiichi Sankyo Submits Application for Expanded Indication of Enhertu® in Japan

On 4 October 2024, Daiichi Sankyo announced that it has submitted a supplemental new drug application for Enhertu® (trastuzumab deruxtecan) to Japan’s Ministry of Health, Labour and Welfare… Read more here.

1 October 2024 | US | FDA Grants Priority Review of Enhertu® for Patients with HER2-Low or HER2 Ultra-Low Unresectable or Metastatic Breast Cancer

On 1 October 2024, AstraZeneca and Daiichi Sankyo’s supplemental Biologics Licence Application for Enhertu® (fam-trastuzumab deruxtecan-nxki) was granted priority review by the US FDA… Read more here.

Ustekinumab

11 October 2024 | US | Approval Alert: FDA Approves Fourth US Ustekinumab Biosimilar

On 11 October 2024, Meiji Seika Pharma Co., Ltd. announced that the US Food and Drug Administration (FDA) has approved its Imuldosa™ (DMB-3115, ustekinumab-srlf), biosimilar to Janssen’s Stelara® (ustekinumab)… Read more here.

9 October 2024 | EU | Bio-Thera Solutions and Gedeon Richter Seal Ustekinumab Biosimilar Commercialisation Deal

On 9 October 2024, Bio-Thera Solutions and Gedeon Richter announced that they have entered into an exclusive commercialisation and license agreement for BAT2206, biosimilar to Janssen’s Stelara® (ustekinumab) … Read more here.

Biopharma Deals 2024

3 October 2024 | Teva/mAbxience Global Licensing Deal for Anti PD-1 Oncology Biosimilar Candidate

On 3 October 2024, Teva Pharmaceuticals and mAbxience (majority owned by Fresenius Kabi) each announced that they have entered into a new global licensing agreement for the development of an unnamed anti PD-1 oncology biosimilar candidate… Read more here.

Company Announcements

1 October 2024 | US | J&J Announce $2b Investment in State-of-the-Art US Biologics Manufacturing Facility

On 1 October 2024, Johnson & Johnson (J&J) announced a $2b investment in a new, advanced technology biologics manufacturing facility in North Carolina… Read more here.

About Pearce IP

Naomi Pearce

CEO, Executive Lawyer (AU, NZ), Patent & Trade Mark Attorney (AU, NZ)

Chantal Savage

Special Counsel, Lawyer

Nathan Kan

Graduate (Law)

FDA Approves UCB’s 320mg Single-Injection Device Presentations of Bimzelx® (Bimekizumab)

Oct 14, 2024

On 14 October 2024, UCB announced that the US FDA has approved a 2 mL pre-filled syringe and pre-filled autoinjector, each containing 320 mg of Bimzelx® (bimekizumab-bkzx), adding to the already approved 1 ml (160 mg) device presentation.

On 23 September 2024, UCB received FDA approval for three new indications of Bimzelx®, including active psoriatic arthritis, active non-radiographic axial spondyloarthritis with objective signs of inflammation and active ankylosing spondylitis. This followed US approval of Bimzelx® in October 2023 for moderate-to-severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy.

In April 2024, Australia’s PBAC recommended Bimzelx® for listing on the PBS for severe psoriatic arthritis. Bimzelx® is also potentially in line for PBS-listing for psoriatic arthritis and ankylosing spondylitis, having previously been listed for chronic plaque psoriasis.

AstraZeneca/Daiichi’s Enhertu® Receives Conditional Approval in China

Oct 14, 2024

On 14 October 2024, AstraZeneca, in partnership with Daiichi Sankyo, announced that Enhertu® (trastuzumab deruxtecan) has received conditional approval in China for use as monotherapy in patients with unresectable, locally advanced or metastatic non-small cell lung cancer whose tumours have activating HER2 mutations and who have already undergone systemic therapy. Final approval of this indication depends on the success of the drug in a confirmatory clinical trial.

In August this year, Enhertu® was conditionally approved in China as a monotherapy treatment for patients with locally advanced or metastatic HER2-positive gastric or gastroesophageal junction adenocarcinoma who have received two or more prior treatment regimens. Enhertu® has previously been approved for HER2-low breast cancer in Japan (March 2023), China (July 2023) and the US (August 2022).

Approval Alert: US Approval of Pfizer’s Hympavzi™ (Marstacimab) for Haemophilia

Oct 11, 2024

On 11 October 2024, Pfizer announced that the US FDA has approved its Hympavzi™ (marstacimab-hncq) for the treatment of adults and adolescents with haemophilia A or B without inhibitors. The approval is based on results from the Phase 3 BASIS trial (NCT03938792) demonstrating substantial bleed reduction compared to routine prophylaxis and on-demand treatment in eligible patients with haemophilia A or B without inhibitors.

Hympavzi™ is the first and only anti-tissue factor pathway inhibitor (anti-TFPI) approved in the US for treating haemophilia A and B, and the first that can be delivered using a pre-filled auto-injector pen.

This news follows the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) adopting a positive opinion for Hympavzi™ for bleeding episodes in patients aged 12 years and older with sever haemophilia A or B in September 2024.

Delhi High Court Refuses Interim Injunction Against Zydus’ Pertuzumab Biosimilar

Oct 11, 2024

The Delhi High Court has now dismissed an application filed by Roche seeking injunction against Zydus’ breast cancer drug Sigrima™.

Roche alleged that Zydus had infringed two of its patents for its HER2 positive breast cancer drug Perjeta®. In dismissing Roche’s application, the Court held that Roche had not established that Zydus’ product was likely to, or was actually infringing Roche’s patents.

Approval Alert: FDA Approves Fifth US Ustekinumab Biosimilar

Oct 11, 2024

The FDA approval follows Accord BioPharma’s announcement in January 2024 that the FDA had accepted its Biologics Licence Application (BLA) for DMB-3115. DMB-3115 was jointly developed by Dong-A St and Meiji Seika Pharma, which granted Intas Pharmaceuticals (Accord BioPharma’s parent company) exclusive licensing rights worldwide excluding certain Asian countries, in an agreement announced in 2021. Under the agreement, Accord BioPharma is responsible for US commercialisation.

In October 2023, Accord BioPharma reached a settlement with Janssen that allows Accord to launch DMB-3115 in the US no later than 15 May 2025.

Previously approved ustekinumab biosimilars in the US are Samsung Bioepis’ Pyzchiva®(SB17, July 2024), Alvotech/Teva’s Selarsdi™ (April 2024), Amgen’s Wezlana® (October 2023) and Formycon/Fresenius Kabi’s Otulfi® (FYB202, September 2024).