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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.

Dupilumab Study Shows Promising Results for Asthma Patients

Feb 8, 2024

A Sanofi and Regeneron study published on 11 December 2023 found that dupilumab (compared to placebo) significantly improved lung function in children with uncontrolled asthma. The study was randomised with subjects aged between 6-12 years, and the results showed that by week 12, a higher proportion of patients achieved a clinically meaningful response.

On 25 January 2024, Regeneron and Sanofi announced that the FDA approved Dupixent® (dupilumab) to treat paediatric patients, aged 1 to 11 years and weighing at least 15 kg, with eosinophilic esophagitis (EoE).

Samsung Biologics and LegoChem Biosciences Partner to Develop and Manufacture ADCs

Feb 7, 2024

On 7 February 2024, global contract development and manufacturing company Samsung Biologics announced that it has partnered with LegoChem Biosciences for antibody-drug conjugate (ADC) development and manufacturing. Under the agreement, Samsung Biologics will provide antibody development and drug substance manufacturing services as part of LegoChem Bioscience’s ADC program designed to treat solid tumours. LegoChem is aiming to submit an Investigational New Drug (IND) application to the FDA in the first half of 2025.

Samsung Biologics also reports that it is on track to complete a dedicated ADC facility in South Korea in 2024. Two weeks ago, Samsung Biologics revealed in its Q4 2024 Earnings its record high operating profit of over ₩1T for 2023.

Celltrion to Supply Yuflyma® (adalimumab) and Remsima SC® (infliximab) to Norway

Feb 7, 2024

On 7 February 2024, the Korea IT Times reported that Celltrion announced that it has won the Norwegian government’s tender to supply Remsima SC® (infliximab biosimilar) and Yuflyma® (adalimumab biosimilar) until 2026.

Celltrion aims to expand further into the Nordic area with plans to enter into Denmark with Remsima SC® sometime in 2024.

FDA accepts BMS’ sBLA for Neoadjuvant Opdivo® (nivolumab)

Feb 7, 2024

On 7 February 2024, Bristol Myers Squibb (BMS) announced the FDA’s acceptance of its supplemental Biologics License Application (sBLA) for neoadjuvant Opdivo® (nivolumab) with chemotherapy followed by surgery + adjuvant Opdivo® in the treatment of resectable stage IIA to IIIB non-small cell lung cancer (NSCLC). The FDA has assigned a PDUFA goal date of 8 October 2024.

On 5 December 2023, BMS announced that the FDA has accepted for priority review its sBLA for Opdivo® in combination with cisplatin-based chemotherapy for the treatment of unresectable or metastatic urothelial carcinoma.

Pearce IP BioBlast w/e 02 Feb 2024

Feb 5, 2024

2 FEB 2024 | EU | US | Regeneron’s linvoseltamab MAA Filing Accepted by EMA; BLA Submitted to FDA for Multiple Myeloma

Regeneron announced that its marketing authorisation application (MAA) for linvoseltamab to treat adult patients with relapsed/refractory (R/R) multiple myeloma (MM), was accepted for review by the European Medicines Agency (EMA). The MAA is supported by data from a Phase I/II trial (LINKER-MM1) investigating linvoseltamab in R/R MM. Regeneron also submitted a Biologics License Application (BLA) to the FDA in December 2023.

2 FEB 2024 | Shanghai Henlius Biotech Announces Successful Completion of PK Phase I Denosumab Study

Shanghai Henlius Biotech announced its phase 1 clinical study for its denosumab biosimilar of HLX14, which met the primary endpoint.

Shanghai Henlius Biotech announced commencement of the study in November 2020. Organon announced a deal in June 2022 for exclusive global commercialisation rights to Shanghai Henlius Biotech’s denosumab and pertuzumab.

1 FEB 2024 | Merck Announces Q4 2024 and Full Year Financial Results

Merck published its Q4 and full year financial results, reporting Q4 2023 worldwide sales were US$14.6B, a 6% increase from Q4 2022. It also reported a 19% increase in sales of Keytruda® (pembrolizumab) worth US$25B across 2023. Merck explained the Keytruda® sales increase was due to increased global uptake in earlier-stage and metastatic indications.

Merck highlighted that Keytruda® received multiple FDA approvals, including in combination with Padcev®. It also reiterated that the FDA granted Priority Review of Merck and Daiichi Sankyo’s Biologics License Application for patritumab deruxtecan to treat certain patients with previously treated locally advanced or metastatic EGFR-mutated non-small cell lung cancer.

1 FEB 2024 | KR | Samsung Bioepis and Samil Pharmaceutical to Co-Market SB15 Biosimilar to Regeneron’s Eylea® (aflibercept)

Korea Biomedical Review reported that Samsung Bioepis and Samil Pharmaceutical will co-market SB15, Samsung’s biosimilar of Regeneron’s Eylea® (aflibercept) in Korea. The agreement intends to utilise Samsung’s R&D capabilities with Samil Pharmaceuticals’ sales and marketing expertise.

On 21 June 2022, Samsung Bioepis and Samil also entered a commercialisation agreement for Amelivu®, a biosimilar to Genentech’s Lucentis® (ranibizumab).

1 FEB 2024 | Novo Nordisk Announce 2023 Financial Results in Annual Report

Novo Nordisk announced in its 2023 Annual Report that it has increased sales by 31% to DKK 232.3B in 2023, and increased its operating profit by 37% in Danish Kroner. Key developments outlined in the Report include:

a 51% net profit increase and 49% increase in share price;
a total of DKK75B investment in expanding global production sites in 2023;
40.5M people accessed Novo Nordisk’s diabetes care products;
a summary of the SELECT trial which showed cardiovascular benefits of semaglutide, including a 20% reduction in major adverse cardiovascular events compared to a placebo; and
an update on Novo Nordisk’s pending proposed once-weekly insulin product (Insulin icodec) which has been filed in US, EU and PRC.

31 JAN 2024 | Outlook Therapeutics Doses First Subject in Clinical Trial Evaluating ophthalmic bevacizumab in Wet AMD Patients

Outlook Therapeutics announced that it has dosed the first subject in its clinical trial (NORSE EIGHT) which aims to evaluate the effect of ophthalmic formulation of bevacizumab (ONS-5010), in patients suffering from neovascular age-related macular degeneration (wet AMD).

On 23 January 2024, Outlook Therapeutics announced that it received approval from FDA under a Special Protocol Assessment for its ONS-5010 clinical trial protocol.

31 JAN 2024 | DE | First Biosimilar Launch: Sandoz Launches Polpharma Developed Tyruko® (natalizumab) in Germany

Sandoz announced that it launched biosimilar natalizumab (Tyruko®) in Germany on 31 January 2024 for the treatment of adults with highly active relapsing remitting multiple sclerosis (RRMS). Tyruko® was developed by Polpharma Biologics and is the first biosimilar to Biogen’s Tysabri® (natalizumab) to be launched in Europe.

The EC approved Sandoz’s Tyruko® in September 2023, and it was approved by the FDA in August 2023.

30 JAN 2024 | US | J&J Submits sBLA to FDA for Darzalex Faspro® (daratumumab and hyaluronidase-fihj) Combination

Johnson & Johnson announced it submitted a supplemental Biologics License Application (sBLA) to the FDA seeking approval for DARZALEX FASPRO® (daratumumab and hyaluronidase-fihj) in combination with bortezomib, lenalidomide and dexamethasone for induction and consolidation treatment, and with lenalidomide for maintenance treatment of adult patients who are newly diagnosed with multiple myeloma (NDMM) and are eligible for autologous stem cell transplant.

In December 2021, Xbrane Biopharma announced it was developing a biosimilar to Darzalex® (daratumumab).

29 JAN 2024 | US | FDA Grants Priority Review of AZ/Daiichi Sankyo’s Enhertu®

AstraZeneca and Daiichi Sankyo announced that the FDA has accepted its supplemental Biologics License Application (sBLA) for Enhertu® (trastuzumab deruxtecan) and has granted Priority Review to treat patients with unresectable or metastatic HER2-positive (immunohistochemistry [IHC] 3+) solid tumours who have received prior treatment or who have no satisfactory alternative treatment options.

On 18 October 2023, the European Commission approved Enhertu® to treat a new indication: monotherapy for the treatment of adult patients with advanced non-small cell lung cancer (NSCLC) whose tumours have an activating HER2 (ERBB2) mutation and who require systemic therapy following platinum-based chemotherapy with or without immunotherapy.

29 JAN 2024 | Alvotech Reports Positive Top-line Results from Study on AVT03, Biosimilar to Amgen Inc’s Prolia® and Xgeva® (denosumab)

Alvotech announced positive top-line results for AVT03, its biosimilar to Amgen Inc’s Prolia® and Xgeva® (denosumab). The study (AVT03-GL-P01) was a randomised, double-blind, parallel-group study evaluating the pharmacokinetics, safety, and tolerability of AVT03 compared to Prolia® in healthy adult male subjects 28to 55 years old. The results of the study have not yet been published.

On 7 September 2022, Lupin and partner DKSH announced an exclusive licensing and supply agreement to market Alvotech’s AVT03 and four other Alvotech biosimilar products (golimumab, aflibercept and two undisclosed biosimilars for immunology and oncology) in the Philippines.

28 JAN 2024 | US | Celltrion Submits BLA for CT-P47, Biosimilar to Genentech’s Actemra® (tocilizumab)

Celltrion announced that it has submitted a Biologics License Application (BLA) for CT-P47, biosimilar to Genentech’s Actemra® (tocilizumab), to the FDA. Celltrion is seeking approval for CT-P47 in both intravenous and subcutaneous formulations. Biogen received FDA approval for Tofidence®, its biosimilar Actemra® on 30 September 2023. On 1 August 2022 the FDA accepted Fresenius Kabi’s BLA for its tocilizumab biosimilar.

On 14 December 2023, Celltrion revealed that its phase III clinical trial of CT-P47 demonstrated equivalence with Actemra® in patients with rheumatoid arthritis.

25 JAN 2024 | Study Demonstrates Double Switching From Janssen’s Remicade® (infliximab) to Biosimilars Not Associated with Flares

A study published in Inflammatory Bowel Diseases on 25 January 2024 concluded that 130 US patients with inflammatory bowel disease who switched from Janssen’s Remicade® (infliximab) to two different biosimilars were not associated with flares compared to patients who received Remicade® or underwent a single biosimilar switch.

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.

Sian Hope

Lawyer

Sian is a life sciences focussed intellectual property lawyer with a particular focus on the pharmaceutical, biotechnology and healthcare industries. Her practice is primarily in patent litigation, but includes non-contentious patent matters, trade mark matters, health regulatory legal matters and consumer law.

Rani Therapeutics Releases Encouraging PhI Data for RT-111, Oral Form of Celltrion’s CT-P43 (ustekinumab) Biosimilar 

Feb 5, 2024

On 5 February 2024, Rani Therapeutics published positive topline results from its phase I clinical trial regarding RT-111, a RaniPill® capsule containing Celltrion’s ustekinumab biosimilar, CT-P43 (biosimilar to Janssen’s Stelara®). The study shows that RT-111 was well-tolerated and delivered ustekinumab with high bioavailability.

In June 2023, Rani Therapeutics announced that it expanded its partnership with Celltrion to develop an orally administered adalimumab biosimilar (RT-105), following their earlier collaboration on ustekinumab (CT-P43).

Novartis to Buy MorphoSys AG for €2.7B 

Feb 5, 2024

On 5 February 2024, Novartis announced that it has agreed to acquire MorphoSys AG, a biopharmaceutical company focused on oncology medicines, for around €2.7B. Upon completion of the acquisition, notably, Novartis would add to its portfolio the ‘next generation medicines’ of pelabresib which downregulates blood cancer and tulmimetostat used to treat endometrial cancer.

GSK DREAMM-7 Phase III Trials Demonstrate Superior Results with Blenrep Combination

Feb 5, 2024

On 5 February 2024, Glaxo Smith Kline (GSK) announced results from an interim analysis of its DREAMM-7 phase III trial. The trial compared two treatment combinations, namely:

Blenrep® Combination: Blenrep® (belantamab mafodotin) + BorDex® (bortezomib plus dexamethasone); and
Daratumumab combination: daratumumab + BorDex® (bortezomib plus dexamethasone)

The Blenrep® Combination showed: a) 59% further reduction in risk of disease progression or death, b) 23.2 more months of median progression-free survival, and c) 43% reduction in risk of death.

FDA Grants Fast Track Designation to Ultimovacs ASA’s UV1

Feb 5, 2024

On 5 February 2024, Ultimovacs announced that the FDA has granted a fast-track designation to its therapeutic cancer vaccine UV1 in combination with nivolumab and ipilimumab. This was supported by the results of a phase II clinical trial for the treatment of patients with unresectable malignant pleural mesothelioma. 

Novo Nordisk Parent Acquires Catalent for $16.5B

Feb 5, 2024

On 5 February 2024, Novo Nordisk’s parent company Novo Holdings announced that it will acquire global contract development and manufacture company Catalent for USD $16.5B. 

Novo Holdings will secure 50 global sites in the acquisition and intends to sell three fill-finish sites and related assets (located in Italy, USA and Belgium) to Novo Nordisk. The acquisition is expected to close towards the end of calendar year 2024.  

This news follows the release on 31 January 2024 by Novo Nordisk of its 2023 Annual Report, where it presented an increase in sales by 31% to DKK 232.3B in 2023, representing an increase in its operating profit by 37%.

Novo Nordisk Settles with Two Clinics Selling Ozempic and Wegovy Knock-Offs

Feb 5, 2024

Novo Nordisk settled two lawsuits over counterfeit versions of Ozempic® (semaglutide) and Wegovy® (semaglutide). The two companies involved, Cosmetic Laser Professionals Med Spa and Nuvida RxWeight Loss are permanently banned from claiming that their products are approved by the FDA and from using any Novo Nordisk logos or trademarks.

Rituximab Study Shows Promise for Managing AIBD

Feb 4, 2024

A study published in Medicina, on 4 February 2024, concluded that Rituximab represents an “efficacious and well-tolerated therapeutic option” for the management of Autoimmune Bullous Diseases (AIBD) and warrants consideration in cases of refractory AIBD. 

Regeneron’s linvoseltamab MAA Filing Accepted by EMA; BLA Submitted to FDA for Multiple Myeloma

Feb 2, 2024

Shanghai Henlius Biotech Announces Successful Completion of PK Phase I Denosumab Study

Feb 1, 2024

Shanghai Henlius Biotech announced its phase 1 clinical study for its denosumab biosimilar of HLX14, which met the primary endpoint.

Shanghai Henlius Biotech announced commencement of the study in November 2020. Organon announceda deal in June 2022 for exclusive global commercialisation rights to Shanghai Henlius Biotech’s denosumab and pertuzumab.

Merck Announces Q4 2024 and Full Year Financial Results

Feb 1, 2024

Merck highlighted that Keytruda® received multiple FDA approvals, including Keytruda® plus Padcev®. It also reiterated that the FDA granted Priority Review of Merck and Daiichi Sankyo’s Biologics License Application for patritumab deruxtecan to treat certain patients with previously treated locally advanced or metastatic EGFR-mutated non-small cell lung cancer.

Samsung Bioepis and Samil Pharmaceutical to Co-Market SB15 Biosimilar to Regeneron’s Eylea® (aflibercept)

Feb 1, 2024

On 21 June 2022, Samsung Bioepis and Samil also entered a commercialisation agreement for Amelivu®, a biosimilar to Genentech’s Lucentis® (ranibizumab).

District Court Publishes Detailed Reasons for Decision in Regeneron’s litigation against Mylan and Biocon regarding aflibercept biosimilar

Jan 31, 2024

On 31 January 2024, the US District Court for the Northern District of West Virginia published a redacted version of Judge Thomas Kleeh’s Memorandum Opinion and Order, setting out the detailed reasons for his previous finding that Mylan and Biocon infringed eight claims of Regeneron’s US patent 11,084,865, in respect of formulations of aflibercept such as Eylea®. The Judge found asserted claims of two method of treatment patents (11,253,572 and 10,880,601) to be invalid.

The infringement finding was made in relation to the aflibercept biosimilar Yesafili®. Mylan filed a Biologics Licence Application (BLA) for Yesafili® in October 2021 seeking FDA approval to market it. Mylan’s rights in the Yesafili® BLA were later transferred to Biocon, who intended to sell the product in the US.

On 27 December 2023, Judge Kleeh issued a short-form judgment setting out his conclusions. At that time, the detailed reasons remained under seal. Mylan and Biocon and Regeneron filed “protective” notices of appeal from the short form judgment on 26 January 2024, although the parties allege that the 27 December judgment was not a final, appealable one.

Biocon has received marketing approval for Yesafili® from the UK Medicines and Healthcare products Regulatory Agency (November 2023) and from the European Commission (September 2023).

Novo Nordisk Announce 2023 Financial Results in Annual Report

Jan 31, 2024

a 51% net profit increase and 49% increase in share price;
a total of DKK75B investment in expanding global production sites in 2023;
40.5M people accessed Novo Nordisk’s diabetes care products;
a summary of the SELECT trial which showed cardiovascular benefits of semaglutide, including a 20% reduction in major adverse cardiovascular events compared to a placebo; and
an update on Novo Nordisk’s once-weekly insulin product (Insulin icodec).

Outlook Therapeutics Doses First Subject in Clinical Trial Evaluating ophthalmic bevacizumab in Wet AMD Patients

Jan 31, 2024

On 23 January 2024, Outlook Therapeutics announced that it received approval from FDA under a Special Protocol Assessment for its ONS-5010 clinical trial protocol.

First Biosimilar Launch: Sandoz Launches Polpharma Developed Tyruko® (natalizumab) in Germany

Jan 31, 2024

The EC approved Sandoz’s Tyruko® in September 2023, and it was approved by the FDA in August 2023.

Biogen Redirects Resources from Aduhelm® (aducanumab) to Advance Leqembi® (lecanemab)

Jan 31, 2024

Biogen announced it will reprioritise resources allocated to Aduhelm® (aducanumab) to advance Leqembi® (lecanemab) to “develop new treatment modalities”. Biogen will discontinue development and commercialisation of Aduhelm® 100 mg/mL IV injection and will terminate the current clinical study.

On 22 April 2022, Biogen withdrew its EU MAA for aducanumab following feedback from the CHMP.

Astellas Submits sNDA for Padcev® (enfortumab vedotin) with Merck’s Keytruda® in Japan

Jan 31, 2024

Astellas announced it submitted a Supplemental New Drug Application (sNDA) to the Japanese Ministry of Health, Labour and Welfare for Padcev® (enfortumab vedotin (genetical recombination)) with Merck’s Keytruda® (pembrolizumab (genetical recombination)) as a combination therapy for the first-line treatment of adult patients with previously untreated locally advanced or metastatic urothelial cancer (la/mUC).

On 15 December 2023, Keytruda® in combination with Pfizer/Astellas’ Padcev® (enfortumab vedotin-ejfv) was approved by the FDA to treat locally advanced or metastatic urothelial carcinoma. On 26 January 2024, the EMA approved a Type II variation for the same indication.

Study Finds No Difference in Disease Activity when Comparing GP2015/SB4 (etanercept biosimilars) and GP2017 (adalimumab biosimilar) to their Originator Drugs

Jan 31, 2024

A study by the Italian University of Bologna published in Springer Link’s Clinical Drug Investigation, found that Sandoz’s GP2015 (etanercept biosimilar), Samsung Bioepis’ SB4 (etanercept biosimilar) and Sandoz’s GP2017 (adalimumab biosimilar) have equivalent effectiveness over a long period of time, compared to originator medicines etanercept and adalimumab respectively. The study recruited a total of 1598 patients with rheumatoid arthritis and monitored them for over 48 months during treatment.