Home / News / BioBlast® / Biosimilar Deals 2021

EXPLORE OUR

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.

Blockbuster Copies and Expansions Ahead in AU – Saxenda®, Opdivo®, Ozempic® & More

Nov 4, 2024

Australia’s Therapeutic Goods Administration (TGA) has updated its online list of prescription medicines for evaluation for the months of August, September and October.

Among the new applications to be reviewed is Freyr’s new application for liraglutide (Lobezyl ®). This follows TGA acceptance of Cipla’s liraglutide for review in October 2023 and Sun Pharma’s in January 2024. Novo Nordisk’s Saxenda® (liraglutide) was approved in Australia in 2015 for weight management.

Meanwhile, an application for a new indication for Novo Nordisk’s Ozempic® (semaglutide), for reducing risk of kidney failure, was accepted for review in September 2024.

Applications for new indications for BMS’ Opdivo® (nivolumab) and Yervoy® (ipilimumab) have also been accepted for review (in October and September 2024, respectively), for the treatment of advanced hepatocellular carcinoma or hepatocellular carcinoma that cannot be removed surgically.

AstraZeneca has two applications for expanded indications under review: Imfinzi® (durvalumab) for the treatment of patients with limited-stage small cell lung cancer; and Enhertu® (trastuzumab deruxtecan) for the treatment of adult patients with metastatic NSCLC or NSCLC that cannot be removed surgically.

Other applications for new indications of biopharmaceuticals currently under evaluation by the TGA include:

Janssen’s Tremfya® (guselkumab) for the treatment of adult patients with moderately to severely active ulcerative colitis or Crohn’s disease;
Eli Lilly’s Omvoh® (mirikizumab) for the treatment of ulcerative colitis in adults who have not benefited from conventional treatments; and
Roche’s Columvi® (glofitamab) for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma.

Alvotech/Advanz Announce EMA Acceptance for Biosimilar to J&J’s Simponi® (Golimumab) Confirming World First

Nov 4, 2024

On 4 November 2024, Alvotech and Advanz Pharma announced that the European Medicines Agency (EMA) has accepted their marketing authorisation application (MAA) for AVT05, biosimilar to Janssen’s Simponi® (golimumab), for treatment of several chronic inflammatory diseases. This is thought to be the first golimumab biosimilar MAA to be filed and accepted anywhere in the world. Alvotech/Advanz expect the approvals process to be completed in Q4 2025.

In April 2024, Alvotech was the first company to publicly announce positive topline results from a patient study evaluating a biosimilar candidate to Simponi® or Simponi Aria®. In November 2023, Alvotech announced that its pharmacokinetic study for AVT05 met its primary endpoint.

Alvotech and Advanz Pharma entered into a master license and supply agreement in May 2023 to commercialise and supply AVT05 in Europe. The agreement also included AVT16 (biosimilar to Takeda’s Entyvio® (vedolizumab) and three early stage, undisclosed biosimilar candidates.

Telehealth Provider Plans to Offer Generic Liraglutide in the US From 2025

Nov 4, 2024

NYSE-listed telehealth provider, Hims & Hers Health Inc, announced in its third quarter 2024 earnings conference call that it plans to bring generic liraglutide to its platform in 2025. The company says it has already confirmed a core supplier and expects to complete test and batch validation over the next few months.

Generic liraglutide products are already approved in the US, EU, UK and India, and are under consideration in Australia.

Originator Novo Nordisk supplies liraglutide as Victoza® and Saxenda®.

Celltrion’s Ustekinumab Biosimilar Launched in EU

Nov 4, 2024

On 4 November 2024, the Korea Hearld reported that Celltrion has launched SteQeyma®, biosimilar to Janssen’s Stelara® (ustekinumab), in Germany and the Netherlands. At the same time, the Korea Herald reported that Celltrion has already secured a bid from the Dutch pharmaceutical procurement group, iZAAZ, which will cover approximately 27% of the ustekinumab market in the Netherlands, with SteQeyma® expected to be supplied for about two years starting this month. Celltrion plans to launch SteQeyma® in Finland in mid-November and in Ireland in late November 2024.

Celltrion is the third company to launch an ustekinumab biosimilar in Europe. On 22 July 2024, STADA and Alvotech announced the launch of biosimilar ustekinumab Uzpruvo® across the majority of European countries. Then, on 25 July 2024, Sandoz announced the European launch of Pyzchiva®. We can expect more ustekinumab biosimilar launches in Europe in the coming months, with many companies having already received EMA regulatory approval. Previously approved ustekinumab biosimilars in Europe include Formycon/Fresenius’ Otulfi®/FYB202 (September 2024), Samsung Bioepis’ Eksunbi™ (September 2024) and Amgen’s Wezenla™ (June 2024). Bio-Thera’s MAA for BAT2206 (ustekinumab) was also accepted by the EMA in July 2024.

Novo Nordisk Set to Expand Use of Semaglutide to Liver Health

Nov 1, 2024

On 1 November 2024, Novo Nordisk announced positive results from part 1 of a pivotal phase 3 study evaluating the effects of once-weekly semaglutide 2.4 mg in adults with metabolic dysfunction-associated steatohepatitis (MASH) and moderate to advanced liver fibrosis.

The trial (ESSENCE) is reported to have shown significant improvement in liver fibrosis and resolution of steatohepatitis without worsening liver conditions in the semaglutide group compared to placebo. After 72 weeks, 37% of semaglutide-treated participants saw improvement in liver fibrosis with no worsening of steatohepatitis, while 62.9% achieved resolution of steatohepatitis with no worsening of fibrosis, demonstrating the efficacy and tolerability of semaglutide.

The ESSENCE trial is a two-part, 240-week study designed to assess the long-term impact of semaglutide on liver health and clinical outcomes in MASH patients. Novo Nordisk plans to seek regulatory approvals based on the trial results in the US and EU by mid-2025. Final results from part 2 of the trial are expected in 2029.

This news follows Novo Nordisk’s announcement in October 2024 of positive results from its semaglutide 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).

NZ’s Pharmac Proposes Increased Reimbursement Regime for Amgen’s Denosumab

Oct 31, 2024

On 31 October 2024, New Zealand’s drug funding body, Pharmac, announced that it is seeking feedback on a proposal to broaden the reimbursement for Amgen’s denosumab products Xgeva® and Prolia®.

Both Xgeva® (70mg/ml solution for injection, for various bone-related cancer indications) and Prolia® (60mg/ml, for severe osteoporosis) are approved in New Zealand, but only Prolia® is currently funded by Pharmac. The Pharmac proposal would result in a new strength and presentation of Xgeva® (120 mg solution for injection) being listed for hypercalcaemia associated with cancer from 1 February 2025 and widened access to Prolia®, for more people with osteoporosis, from 1 March 2025 (in both cases subject to eligibility criteria).

Pharmac reports that the expansion could benefit 1,900 people initially, growing to 12,500 within five years.

Public consultation on the proposal is open until 14 November 2024.

Eisai Completes Fast-Tracked BLA for Leqembi® (Lecanemab-irmb) Maintenance Dose Autoinjector

Oct 31, 2024

Following the FDA granting Fast Track designation, Eisai reports that it has completed its rolling submission of a Biologics License Application (BLA) to the FDA for Leqembi® (lecanemab-irmb) subcutaneous autoinjector for weekly maintenance dosing for the treatment of early Alzheimer’s Disease (AD).

The autoinjector will serve as a more convenient method of administration for patients at home or in medical facilities. The subcutaneous autoinjector weekly maintenance regimen will allow patients who have completed the biweekly intravenous initiation phase of treatment to receive weekly doses that maintain effective drug concentrations to sustain the clearance of highly toxic protofibrils that can continue to cause neuronal injury even after the plaque has been cleared from the brain.

This news follows approval of Leqembi® in the UK for the treatment of mild cognitive impairment (MCI) and mild dementia due to Alzheimer’s disease in August 2024. Leqembi® has previously been approved for MCI and mild dementia due to Alzheimer’s disease in the 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 October 2024, Australia’s TGA decided against registering Leqembi® for these indications due to safety and efficacy concerns.

MSD’s Keytruda® Sales for Q3/24 Reach US $7.4B

Oct 31, 2024

On 31 October 2024, Merck, known as MSD outside the US and Canada, published its Q3 2024 financial results, including 17% growth (21% excluding foreign exchange impact) in Keytruda® (pembrolizumab) sales, to US $7.4 billion. This growth is attributed to increased global uptake in earlier-stage indications of Keytruda®, including triple-negative breast cancer, renal cell carcinoma and non-small cell lunch cancer (NSCLC), together with continued global demand for metastatic indications.

The increased global uptake of Keytruda® is reported to have helped drive MSD’s total global sales for Q3 2024 to US$16.7 billion, an increase of 4% year on year.

Recent regulatory milestones for Keytruda® include: the FDA approval in September 2024 of Keytruda® plus pemetrexed and platinum chemotherapy as first-line treatment for unresectable advanced or metastatic malignant pleural mesothelioma; approvals in Europe for Keytruda® plus Padcev® as first-line treatment of unresectable or metastatic urothelial carcinoma (September 2024) and two gynaecological cancers (October 2024, marking the 30^th EU approval); and approvals in Japan for certain patients with NSCLC and for radically unresectable urothelial carcinoma (September 2024).

NICE Recommends Outlook Therapeutics’ Ophthalmic Bevacizumab for Wet AMD

Oct 31, 2024

Outlook Therapeutics’ ophthalmic formulation of bevacizumab, Lytenava™ (ONS-5010, bevacizumab gamma), has been recommended by the National Institute for Health and Care Excellence (NICE) as a NHS treatment option for wet age-related macular degeneration (AMD).

Lytenava™ was approved in the UK for wet AMD in July 2024 following its submission to the MHRA under the International Recognition Procedure (IRP). The UK approval followed marketing authorisation granted to Lytenava™ in the EU in May 2024.

Outlook Therapeutics is currently undertaking a clinical trial to assess the effectiveness of Lytenava™ for use in wet AMD for the purpose of resubmission of its Biologics Licence Application to the US FDA. This follows receipt of a Complete Response Letter from the FDA and submission of a Special Protocol Assessment (SPA) request in 2023.

Celltrion & Daewoong Pharmaceutical to Jointly Sell Denosumab Biosimilar in Korea

Oct 31, 2024

On 31 October 2024, Daewoong Pharmaceutical announced that it has entered a joint sales agreement with Celltrion under which the two companies will jointly promote Celltrion’s CT-P41, biosimilar to Amgen’s Prolia® (denosumab), in Korea. CT-P41 is scheduled to be launched in the first half of 2025 in Korean hospitals and clinics.

This follows Celltrion’s presentation of 78 week results of its Phase 3 study of CT-P41 in April 2024, and the publication of those results in August 2024.

Celltrion filed an aBLA for CT-P41 in the US in December 2023 and, in May 2024, was sued by Amgen in the US District Court of New Jersey for alleged infringement of 29 patents regarding denosumab. That litigation is ongoing.

FDA Accepts Organon/Shanghai Henlius’ BLA for Biosimilar Denosumab

Oct 30, 2024

Organon and Shanghai Henlius Biotech announced on 30 October 2024 that the FDA accepted their BLA for HLX14, biosimilar to Amgen’s Prolia® and Xgeva® (denosumab). This comes 5 months after the European Medicines Agency (EMA) validated Henlius’ and Organon’s applications for denosumab in May 2024.

Sandoz’s Wyost® and Jubbonti® were the first denosumab biosimilars approved in the US in March 2024. US BPCI litigation commenced by Amgen against Sandoz in May 2023 in relation to denosumab was resolved in April 2024, enabling Sandoz to launch Jubbonti® and Wyost® from 31 May 2025, or earlier in certain (undisclosed) circumstances. No other denosumab biosimilars are currently approved in the US, although Fresenius Kabi’s BLA for its denosumab biosimilar was accepted by the FDA in May 2024 and Teva’s BLA for TVB-009P (denosumab) was accepted by the FDA in October 2024.

In June 2022, Shanghai Henlius entered into a licence agreement with Organon regarding HLX14 (and pertuzumab) under which Organon has exclusive global commercialisation rights for all countries except China, Hong Kong, Macau and Taiwan.

Celltrion’s Positive Results in Study Comparing Infliximab SC Monotherapy and Immunosuppressant Combination Therapy

Oct 30, 2024

On 30 October 2024, Celltrion announced results of a global phase 3, 2-year follow-up study comparing infliximab SC (CT-P13, Zymfentra™) as monotherapy and in combination with immunosuppressants. Celltrion reports that the study found Zymfentra™ as monotherapy was just as effective and safe as when combined with immunosuppressants for patients with Crohn’s disease or ulcerative colitis, suggesting “monotherapy can be a sufficiently safe and effective treatment option”. The results were presented at the 2024 American College of Gastroenterology conference (25-30 October 2024).

This news follows Celltrion’s 19 August 2024 announcement that the FDA has approved a phase 3 clinical trial of Zymfentra™ for rheumatoid arthritis.

Zymfentra™ was the first subcutaneous formulation of infliximab approved by the FDA for ulcerative colitis and Crohn’s disease in October 2023. It was launched in the US in March 2024.

In Europe, Zymfentra™ is known as Remsima SC® and has been approved since 2013.

Novo Nordisk’s Wegovy® and Ozempic® US Supply Crisis Over

Oct 30, 2024

On 30 October 2024, the US Food and Drug Administration (FDA) provided an update on its drug shortage database, reporting that all doses of Novo Nordisk’s popular weight loss injection Wegovy® and diabetes drug Ozempic® (both of which comprise semaglutide) are now available in the US. This demonstrates Novo Nordisk’s ability to increase supply amid growing demand.

Novo Nordisk stated to US media that all doses are now shipped regularly to wholesalers, thanks to expanded manufacturing capacity and close communication with the FDA. Novo Nordisk emphasised a gradual supply increase to ensure patient care and track prescribing trends.

Sandoz’s Q3/9M Results: Strong Biosimilars Growth of 37%/32%

Oct 30, 2024

On 30 October 2024, Sandoz announced its Q3 and 9-month 2024 financial results, reporting third quarter net sales of USD 2.6 billion, up 12% in constant currencies, year-on-year. Net sales for the first 9 months of the year were USD 7.6 billion, an increase of 9% in constant currencies compared to the same period in 2023.

Sandoz experienced strong biosimilars growth of 37% (to USD 741 million) and 32% (to USD 2.1 billion) in constant currencies (YoY) for the quarter and the year to date respectively. This is attributed to the European launches of Pyzchiva® (ustekinumab) in July 2024 and Tyruko® (natalizumab) in January 2024, the Canadian launch of Wyost®/Jubbonti® (denosumab) in August 2024, the acquisition of Cimerli® (ranibizumab) from Coherus announced in January 2024, the uptake of Hyrimoz® (adalimumab) in the US and the continued strong demand for Sandoz’s very first biosimilar Omnitrope® (somatropin).

Key biosimilar milestones for Q3/2024 are reported to include the FDA approvals of Enzeevu^TM (aflibercept) in August 2024 and Pyzchiva® (ustekinumab) in July 2024, and the launch of the first European biosimilar to Janssen’s Stelara®, Pyzchiva® (ustekinumab), in July 2024. Sandoz intends to launch Pyzchiva® in the US in February 2025 in the first wave of biosimilars, while the US-launch of Enzeevu™ is dependent upon factors including the outcome of ongoing BPCIA litigation.

Amgen Launches Aflibercept in the US, Prepares to Launch Ustekinumab & Eculizumab

Oct 30, 2024

Following the Court of Appeals for the Federal Circuit’s denial of Regeneron’s application for injunction against Amgen earlier in October 2024, Amgen confirmed during its earnings call on 30 October 2024 that it has launched Pavblu®/aflibercept (biosimilar to Regeneron/Bayer’s Eylea®) in the US and is preparing to launch Wezlana®/ustekinumab (biosimilar to Amgen’s Stelara®) and Bekemv®/eculizumab (biosimilar to Alexion’s Soliris®) in the first and second quarters of 2025 respectively.

Amgen’s Executive Vice President of Global Commercial Operations Murdo Gordon said:

“Our biosimilar products increased 9% year-over-year in the third quarter. We have fully deployed our team in support of the recent U.S. launch of PAVBLU, a biosimilar to EYLEA. Our teams moved quickly to engage retina specialists, and we’re encouraged by the enthusiastic feedback from customers. Our teams are also ready for the upcoming U.S. launches of WEZLANA, a biosimilar to STELARA and BEKEMV, a biosimilar to Solaris, expected in the first and second quarters of 2025, respectively. Overall, our biosimilars portfolio continues to deliver attractive returns driven by our efficient business model.”

Biocon Biosimilar Business Grows 19% in Q3/2024 Driven by US Oncology and Insulin Franchises

Oct 30, 2024

On 30 October 2024, Biocon Limited announced its financial results for Q3 2024, reporting that while its total consolidated revenue was flat (year on year), it experienced “robust performance” in its biosimilars business with growth of 19% (year on year). Biocon attributes the biosimilar growth to an increase in market share in the US, expansion in Europe and 15 new launches in emerging markets.

Biocon reports that its oncology franchise, including Ogivri® (biosimilar trastuzumab, US launch in December 2019) and Fulphila® (biosimilar pegfilgrastim, US approval in June 2018), has experienced an increase in market share over the quarter (YoY), with the market share for Ogivri® increasing from 11% to 18% and that for Fulphila® increasing from 15% to 21%. Biocon’s insulin products have also grown in market share with unbranded bGlargine and Semglee® (insulin glargine-yfgn) surpassing 15%.

Biosimilar highlights for the third quarter include the EMA’s validation of Biocon’s application for biosimilar denosumab and Biocon’s settlement and licence agreement in August 2024 for Yesintek™ (Bmab 1200), biosimilar to Janssen’s Stelara® (ustekinumab), permitting Biocon to launch in Europe, the UK, Canada and Japan following regulatory approval. Biocon had previously entered a settlement agreement with Janssen in relation to ustekinumab in May 2024, allowing US launch in February 2025. The FDA accepted Biocon’s BLA for Bmab 1200 for review under the 351(k) pathway in May 2024.

In emerging markets, Biocon specifically refers to launches of biosimilar bevacizumab and pegfilgrastim in Saudi Arabia and regulatory approvals for biosimilars of bevacizumab, etanercept, adalimumab, insulin aspart and rh-insulin in several countries in the Latin American, African and Middle East regions.

Biocon’s licensing and supply agreement with Tabuk Pharmaceutical for commercialisation of its GLP-1 products for diabetes and chronic weight management in certain Middle East countries and its exclusive distribution and supply agreement with a leading pharmaceutical company in Brazil (October 2024) for commercialisation of liraglutide (generic of Novo Nordisk’s Victoza®/Saxenda®) are also said to be Q3 2024 highlights.

Litigation Update: Court Dismisses Janssen’s Ustekinumab Patent Infringement Counterclaim against Samsung Bioepis

Oct 29, 2024

On 29 October 2024, the Canadian Federal Court dismissed Janssen’s motion to add an infringement counterclaim against Samsung Bioepis in existing patent proceedings. Samsung Bioepis commenced proceedings against Janssen seeking to impeach (invalidate) Janssen’s CA Patent 3,113,837 for Stelara® (ustekinumab) in November 2023.

Samsung commenced the impeachment proceedings as an interested person, on the basis that it had filed a submission for a notice of compliance (NOC) for Pyzchiva®, biosimilar to Stelara® (ustekinumab). Samsung received an NOC for Pyzchiva® in August 2024. At that time, Health Canada published a product monograph for Pyzchiva®, which listed Sandoz as a distributor of Pyzchiva®.

The Federal Court dismissed Janssen’s motion to add an infringement counterclaim because it was not satisfied that the proposed pleading was adequately particularised, and considered that it did not disclose a reasonable cause of action. The Court stated that, “considering the allegations of direct and induced infringement, both individually and collectively, it is apparent that Janssen does not know what Samsung and Sandoz are presently doing with Pyzchiva beyond obtaining regulatory approval, but is hoping to use the discovery process to find out. This is not a proper pleading”.

Ahead of Samsung Bioepis and Sandoz in Canada with ustekinumab biosimilars are: JAMP who launched the Alvotech developed first biosimilar Jameteki™ on 1 March 2024, Amgen who launched Wezlana™ on 4 March 2024 and Celltrion who reported on 31 July 2024 its Canadian approval for Steqeyma (CT-P43). Biocon has also submitted a Canadian regulatory application, following a signed patent settlement and licence agreement with Janssen which enables Biocon to commercialise its ustekinumab biosimilar “Bmab 1200” in Europe, the United Kingdom, Canada and Japan.

NICE recommends Pfizer’s Elrexfio® (Elranatamab) for NHS Cancer Drugs Fund

Oct 29, 2024

On 29 October 2024, UK’s National Institute for Health and Care Excellence (NICE) recommended Pfizer’s Elrexfio® (elranatamab) for use in the NHS’ Cancer Drugs Fund. The Cancer Drugs Fund provides funding for certain cancer medicines before they have been approved by NICE for use in the NHS. Elranatamab is a sub-cutaneous injection therapy for the treatment of multiple myeloma.

In the media release, the director of medicines evaluation at NICE states that use of Elrexfio® through the Cancer Drugs Fund “will give people access to this promising new fourth-line treatment while longer-term data on its use is collected to establish whether it is clinically and cost effective”.

Elrexfio® is approved for relapsed or refractory multiple myeloma in the US (August 2023) and EU (December 2023).

Eli Lilly’s Kisunla™ (Donanemab) Demonstrates Brain Swelling Reduction in Alzheimer’s Patients

Oct 29, 2024

On 29 October 2024, Eli Lilly announced positive results from the TRAILBLAZER-ALZ 6 Phase 3b study, which demonstrated that patients with early symptomatic Alzheimer’s disease (AD) who received a slightly modified titration of Kisunla™ (donanemab) showed a reduction in amyloid-related imaging abnormalities with oedema/effusion (ARIA-E) at the 24-week primary endpoint. Eli Lilly reports that the modified titration of Kisunla™ lowered ARIA-E to 14% compared to 24% in patients receiving the standard dosing regimen. Eli Lilly is intending to submit this data to global regulators for a potential label update for Kisunla™.

One week earlier, Eli Lilly announced that Kisunla™ was approved in the UK as a treatment for mild cognitive impairment and mild dementia due to Alzheimer’s disease in adult patients who are apolipoprotein E ε4 heterozygotes or non-carriers. Kisunla™ was first approved in the US (July 2024) and subsequently in Japan (September 2024) for the same indication.

New Indication Alert: AstraZeneca’s Fasenra® (Benralizumab) EU-Approved for EGPA

Oct 28, 2024

On 28 October 2024, AstraZeneca announced that the European Commission has approved its Fasenra® (benralizumab) as an add-on treatment for adult patients with relapsing or refractory eosinophilic granulomatosis with polyangiitis (EGPA). The indication received a positive recommendation from the EMA’s CHMP in September 2024, based on positive results from the MANDARA Phase III trial.

This follows FDA approval of Fasenra® for the same indication in September 2024.

Positive Ph 3 Results for J&J’s Tremfya® (Guselkumab) in Crohn’s Disease and Plaque Psoriasis

Oct 28, 2024

On 28 October 2024, Johnson & Johnson (J&J) announced that its Phase 3 GRAVITI study of Tremfya® (guselkumab) in moderately to severely active Crohn’s disease showed “robust” results in subcutaneous induction and maintenance therapy, demonstrating “significant” clinical remission and endoscopic response at 48 weeks. Based on these results, J&J considers that guselkumab could become the first IL-23 treatment to offer both SC and IV induction options for Crohn’s disease.

In a separate Phase 3b study (SPECTREM), sponsored by J&J, Tremfya® was shown to result in clear or almost clear skin in the majority of patients with low body surface area moderate plaque psoriasis with special site involvement who had failed topical treatment. These results were presented on 25 October at the 2024 Fall Clinical Dermatology Conference.

Tremfya® is approved in Europe, the USA and other countries for moderate to severe plaque psoriasis and active psoriatic arthritis. Tremfya® received FDA approval in September 2024 for moderately to severely active ulcerative colitis. J&J submitted applications for approval of Tremfya® for Crohn’s disease to the FDA in June 2024 and in Europe in May 2024.

Pearce IP BioBlast® for the week ending 25 October 2024

Oct 28, 2024

Aflibercept

23 October 2024 | Biocon Switching Study for Aflibercept Confirms Safety & Efficacy

On 23 October 2024, Biocon announced follow-up results from a Phase 3 study of MYL-1701P, biosimilar to Regeneron’s Eylea® (aflibercept). According to Biocon, the study… Read more here.

22 October 2024 | US | Regeneron Fails to Injunct Amgen’s US Aflibercept Biosimilar for Second Time; Amgen to Launch At Risk

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… Read more here.

Daratumumab

23 October 2024 | EU | New Indication Alert: J&J’s Darzalex® (Daratumumab) Quadruplet Regimen for Multiple Myeloma Approved in the EU

On 23 October 2024, Johnson & Johnson (J&J) announced that the European Commission has approved an indication extension for Darzalex® (daratumumab) subcutaneous… Read more here.

Donanemab

23 October 2024 | UK | Approval Alert: Eli Lilly’s Kisunla™ (Donanemab-azbt) UK Approved but Not Reimbursed

On 23 October 2024, Eli Lilly announced that its Kisunla™ (donanemab-azbt) received approval from the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) as… Read more here.

Dupilumab

25 October 2024 | Sanofi’s Q3/24 Global Dupixent® Sales Reach €3.5 billion

On 25 October 2024, Sanofi announced its Q3 2024 results, including strong growth for Dupixent® (dupilumab) across indications and geographies. Sanofi reports that sales… Read more here.

Nivolumab, Certolizumab

21 October 2024 | Update on Xbrane Out-Licensing Nivolumab & Certolizumab Biosimilars

In August 2024, Xbrane commenced its out-licensing process for Xdivane™, biosimilar to BMS’ Opdivo® (nivolumab), and XB003 (previously known as Xcimzane™, BIIB801)… Read more here.

Pembrolizumab

24 October 2024 | EU | Two New Gynaecological Cancer Indications for MSD’s Keytruda® in Europe

On 24 October 2024, MSD announced that Keytruda® (pembrolizumab) has received marketing approvals from the European Commission for two new gynaecological cancer… Read more here.

Semaglutide

22 October 2024 | US | Novo Nordisk Nominates Semaglutide for Inclusion in FDA’s DDC List

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… Read more here.

21 October 2024 | Novo Nordisk Positive Results from Semaglutide Cardiovascular Outcomes Trial

On 21 October 2024, Novo Nordisk announced positive results from the SOUL cardiovascular outcomes trial, which evaluated the impact of Rybelsus® (oral semaglutide)… Read more here.

Ustekinumab

22 October 2024 | US | Alvotech/Teva’s Biosimilar Ustekinumab – Second Presentation FDA Approved

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… Read more here.

21 October 2024 | AU | Approval Alert: Samsung Bioepis Ustekinumab Biosimilar Approved in Australia

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… Read more here.

Company Announcements

23 October 2024 | Samsung Biologics’ Q3/24 Results: Accumulated Revenue at Record High

Samsung Biologics has announced its Q3/2024 financial results, reporting that its accumulated revenue has surpassed KRW 3T for the first time and raising its annual revenue… Read more here.

Biopharma Deals 2024

22 October 2024 | Samsung Biologics’ Record-Breaking Contract Manufacturing Deal Worth USD 1.24B

On 22 October 2024, Samsung Biologics announced that it has entered a contract manufacturing deal worth USD 1.24 billion, with an un-named Asia-based pharmaceutical… Read more here.

About Pearce IP

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.

Imogen Bain

Paralegal

Imogen is a paralegal supporting Pearce IP’s legal and trade mark teams. Imogen prepares patent litigation updates, conducts legal research, and provides paralegal and administrative assistance.

Imogen comes from a background working in hospitality, where she has learnt how to be an effective communicator and work efficiently. Imogen has an interest in the design space, having completed her Certificate III in Design Fundamentals. Her knowledge of the design industry has improved her understanding of the IP realm and has strengthened her passion for IP law. Imogen is a highly disciplined and organised individual who works to assist her colleagues with dedication and optimism.

Positive Results for Eli Lilly’s Ebglyss™ (Lebrikizumab-lbkz)

Oct 25, 2024

On 25 October 2024, Eli Lilly announced results from the Phase 3b ADapt study demonstrating that Ebglyss™ (lebrikizumab-lbkz) improved skin (including hand and face) and itch among patients with moderate-to-severe atopic dermatitis (eczema) who were previously treated with dupilumab.

In September 2024, Eli Lilly published three-year data for Ebglyss™ reportedly showing that more than 80% of adults and adolescents with moderate-to-severe atopic dermatitis who responded to Ebglyss™ at week 16 and continued treatment for up to three years experienced sustained skin clearance with monthly maintenance dosing.

This news follows Eli Lilly’s announcement on 13 September 2024 that Ebglyss® received FDA approval for adults and children 12 years and older with moderate-to-severe atopic dermatitis (eczema) that is not well controlled despite treatment with topical prescription therapies.

Sanofi’s Q3/24 Global Dupixent® Sales Reach €3.5 billion

Oct 25, 2024

On 25 October 2024, Sanofi announced its Q3 2024 results, including strong growth for Dupixent® (dupilumab) across indications and geographies. Sanofi reports that sales of Dupixent® for the quarter have increased globally by 24% to €3.5 billion and are expected to total about €13bn for the full year.

Sanofi’s biopharma highlights for Q3 are reported to include its September 2024 new indication approvals for Dupixent® (COPD in the US and China and CRSwNP adolescents in the US) and for Sarclisa® (isatuximab) (newly diagnosed multiple myeloma (NDMM) in the US).