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Home / News / BioBlast®

 

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.

2024

October 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).

October 24, 2024

On 24 October 2024, MSD announced that Keytruda® (pembrolizumab) has received marketing approvals from the European Commission for two new gynaecological cancer indications.  This means Keytruda® is now approved for 30 indications in Europe, including 5 for gynaecological cancer.

The first new indication is for Keytruda®, in combination with carboplatin and paclitaxel, for first line treatment of primary advanced or recurrent endometrial carcinoma in adults who are candidates for systemic therapy.  This indication was approved by the FDA in June 2024.

The second is Keytruda®, in combination with chemoradiotherapy, for treatment of FIGO (International Federation of Gynaecology and Obstetrics) 2014 Stage III-IVA locally advanced cervical cancer in adults who have not received prior definitive therapy.  This indication was approved by the FDA in January 2024 and in Korea in April 2024.

The new indications received positive CHMP approvals in September 2024.

October 23, 2024

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 demonstrated switching patients with diabetic macular oedema (DME) from Eylea® to MYL-1701P produced comparable results in terms of efficacy, safety and immunogenicity.  The results were presented at the annual meeting of the American Academy of Ophthalmology.

Biocon’s aflibercept biosimilar Yesafili was approved in the US in May 2024.  There are currently four other FDA-approved aflibercept biosimilars: Amgen’s Pavblu (August 2024), Sandoz’s Enzeevu™ (August 2024), Formycon/Klinge’s Ahzantive®/FYB203 (June 2024) and Samsung Bioepis’ Opuviz™/SB15 (May 2024)

Regeneron has sued Biocon, Amgen, Samsung Bioepis, Formycon, Celltrion and Sandoz in US BPCIA litigation regarding aflibercept biosimilars.  A permanent injunction was granted against Biocon on 11 June 2024.  Biocon filed a Notice of Appeal on 21 June 2024.

Biocon’s Yesafili® is currently the only aflibercept biosimilar approved in the EU (September 2023, with UK approval following in November 2023).  Formycon’s MAA application for FYB203 (aflibercept) was accepted by EMA in December 2023 and Alvotech/Advanz Pharma’s MAA for AVT06 (aflibercept) was accepted by EMA in August 2024.  In July 2024, Altos Biologics announced that it submitted an MAA to the EMA for its aflibercept biosimilar ALT-L9, with marketing approval expected in 2025.  At its September 2024 meeting, the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) adopted positive opinions for Sandoz’s Afqlir™ and Samsung Bioepis/Biogen’s Opuviz™.

October 23, 2024

On 23 October 2024, Johnson & Johnson (J&J) announced that the European Commission has approved an indication extension for Darzalex® (daratumumab) subcutaneous formulation in combination with bortezomib, lenalidomide and dexamethasone for adult patients with newly diagnosed multiple myeloma (NDMM) who are eligible for an autologous stem cell transplant (ASCT).

This news follows J&J’s Type II variation application to the European Medicines Agency (EMA), and its submission of a supplemental Biologics License Application to the US FDA for the same indication.

In July 2024, the combination regimen was approved by the FDA for induction and consolidation in patients with newly diagnosed multiple myeloma who are eligible for autologous stem cell transplant.  In March 2024, J&J submitted an application to the European Medicines Agency for Darzalex® (daratumumab) for an indication extension for the treatment of transplant-eligible patients newly diagnosed with multiple myeloma.

October 23, 2024

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 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.  According to Eli Lilly, donanemab is the only amyloid plaque-targeting therapy with evidence to support stopping therapy when amyloid plaques are removed.

Despite this approval, the UK’s National Institute for Health and Care Excellence (NICE) determined that it will not provide coverage of Kisunla™ on the NHS, stating that “the costs of providing donanemab…balanced against the relatively small benefit it provides to patients, means it cannot currently be considered good value for the taxpayer”.

Kisunla™ was first approved in the US (July 2024) and subsequently in Japan (September 2024) for the same indication.  With the UK approval, donanemab becomes the second drug approved by the MHRA as a disease modifying treatment for some people with early-stage Alzheimer’s disease, following the approval of Eisai/Biogen’s Leqembi® (lecanemab) in August 2024.

October 23, 2024

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 growth guidance to +15-20%.  Samsung’s consolidated revenue reached KRW 1.2T for the quarter, an increase of 15% from Q3/2023.

Samsung Biologics’ quarterly highlights include entering into its largest contract manufacturing organisation (CMO) deal to date with an unnamed US based pharmaceutical company valued at KRW 1.7T (USD $1.06b) and securing 17 out of the global top 20 big pharma companies as clients.

Its subsidiary, Samsung Bioepis, reports increased revenue and operating profit of 26% and 38%, respectively, YOY.  Its quarterly highlights include the launch of ustekinumab biosimilar SB17 in Europe (as Pyzchiva® in July 2024) and Korea (as Epyztek™, approved in April 2024), approval of eculizumab biosimilar SB12 in the US (as Epysqli in July 2024) and a positive CHMP opinion for aflibercept biosimilar SB15 in Europe (as Opuviz in September 2024).

October 22, 2024

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 company.  The contract extends until December 2037, with production to occur at Samsung Biologics’ biomanufacturing site in Songdo, South Korea.

Samsung reports that this deal brings the value of its contracts for 2024 to over USD 3.3 billion.  Prior to this contract, Samsung’s largest contract manufacturing deal was worth USD 1.06 billion and was signed in July 2024 with an un-named US-based pharmaceutical company.

October 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.

October 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.

October 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.

BioBlast® extract From October 22, 2024 to October 25, 2024

BioBlast® Editor and Contributing Author

Naomi Pearce, Chantal Savage, Rosie Stramandinoli & Nathan Kan

Naomi Pearce, Chantal Savage, Rosie Stramandinoli & Nathan Kan

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