Other Updates

On 31 January 2025, Celltrion announced that the US FDA has approved its Aptozma™/CT-P47, biosimilar to Roche’s Actemra® (tocilizumab), in both subcutaneous and intravenous formulations for several indications, including rheumatoid arthritis (RA), giant cell arteritis (GCA), systemic juvenile idiopathic arthritis (sJIA), polyarticular juvenile idiopathic arthritis (pJIA) and coronavirus disease 2019 (COVID-19).

The approval follows those for Biogen/Bio-Thera’s Tofidence®/BAT1806 (tocilizumab-bavi) and Fresenius Kabi’s Tyenne® (tocilizumab-aazg), both in September 2023.  Tyenne® was launched in the US in an IV formulation in April 2024 and in a subcutaneous formulation in July 2024.

Celltrion’s Aptozma™ was the first tocilizumab biosimilar to be approved in Korea in December 2024.  The biosimilar, marketed as Avtozma® in the EU, received a positive recommendation by the EMA’s CHMP in December 2024.

On 31 January 2025, Sanofi announced that China’s National Medical Products Administration (NMPA) has approved Sanofi’s Sarclisa® (isatuximab) in combination with bortezomib, lenalidomide, and dexamethasone (VRd), for the treatment of adult patients with newly diagnosed multiple myeloma (NDMM) ineligible for autologous stem cell transplant (ASCT), based on data from the IMROZ phase 3 study.

Days earlier, on 28 January 2025, Pharmiweb reported that the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has also approved Sarclisa® for the same combination therapy and indication.

This follows approval of the isatuximab combo by the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) one week earlier.  The combination therapy was also approved in the US in September 2024.

In November 2024, Sanofi succeeded in an appeal in the UK against the NICE’s June 2024 Final Draft Guidance recommending against Sarclisa® as a regimen alongside pomalidomide and dexamethasone for relapsed relapsed/refractory multiple myeloma (RRMM).

On 31 January 2025, Australia’s Pharmaceutical Benefits Advisory Committee (PBAC) published the outcomes considered at its December 2024 intracycle meeting.

Abbvie’s Humira® (adalimumab) received a number of recommendations, including:

• new PBS listings for enthesitis/spondylitis related JIA and chronic plaque psoriasis for paediatric patients; and
• amended PBS listings for moderate to severe ulcerative colitis and severe Crohn’s disease to allow dose escalation and more flexible dosing.

This follows PBS-listing of Sandoz’s high concentration adalimumab biosimilar, Hyrimoz®, in January 2025.

BMS’ PBS submission for Opdivo® (nivolumab) for the perioperative treatment of patients with resectable non-small cell lung cancer (NSCLC) was not recommended.  BMS has requested a post-PBAC meeting to look for a pathway to achieve PBS-listing for this indication.

Opdivo® is currently under review by Australia’s Therapeutic Goods Administration (TGA) for the treatment of advanced hepatocellular carcinoma or hepatocellular carcinoma that cannot be removed surgically.

On 30 January 2025, Judge Hacon of the Patents Court (England and Wales) ruled that Genentech/Novartis’ UK patent for a formulation of omalizumab (EP (UK) 3 805 248) is valid and infringed by Celltrion.

The decision was delivered in a proceeding commenced by Celltrion at the end of July 2023, seeking to revoke the patent on grounds including lack of novelty, lack of inventive step and insufficiency.  In September 2023, Genentech/Novartis filed a counterclaim for infringement.  Celltrion admitted that it infringed the patent if it was held to be valid.

Celltrion’s omalizumab biosimilar, Omlyclo® (CT-P39), was approved in the UK in July 2024.  It has also received approval in Europe (May 2024),  South Korea (June 2024), Australia (November 2024) and Canada (December 2024).  Celltrion submitted an aBLA in the US for Omlyclo® in March 2024.

The UK Court judgment follows a decision of the Dusseldorf Local Division of the UPC in September 2024, which rejected Novartis/Genentech’s application for a preliminary injunction against Celltrion for “imminent infringement” of the EP ‘248 patent.  This was based on a lack of any “concrete indications” of any “imminent infringement” of the patent by Celltrion.  Although Celltrion had obtained European marketing authorisation for Omlyclo®, the Court found there was insufficient evidence of any specific timeline for price negotiations or that reimbursement applications had been made.  There was also no evidence of any samples actually being provided to potential customers.  In these circumstances, Novartis/Genentech’s application for provisional measures was refused.

Disputes between Novartis/Genentech and Celltrion regarding omalizumab are also ongoing in the Netherlands (with accelerated proceedings on the merits before the District Court of The Hague) and in the European Patent Office (EPO), where Celltrion (and another party) filed an opposition against EP 3 805 248 in October 2023.  In a preliminary opinion issued on 2 September 2024, the Opposition Division of the EPO indicated its view that EP ‘248 is valid.  The oral proceedings in the opposition are due to take place in April 2025.

On 30 January 2025, New Zealand’s Medicines and Medical Devices Safety Authority (Medsafe) provisionally approved AbbVie’s Epkinly® (epcoritamab) in 4mg/0.8mL concentrate and 48mg/0.8mL solution for injection, indicated for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) after two or more lines of systemic therapy.  The approval is subject to AbbVie providing further clinical data by 21 December 2026, unless otherwise agreed with Medsafe.

This news follows provisional approval of the same formulation and indications by Australia’s Therapeutic Goods Administration (TGA) in early January 2025.

At its January 2025 meeting, the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) recommended granting marketing authorisation for four new medicines and expanded indications for eight.

The new medicines include AstraZeneca/Daiichi Sankyo’s Datroway® (datopotamab deruxtecan) for patients with unresectable or metastatic hormone receptor (HR)-positive, HER2- negative breast cancer who have received endocrine therapy and at least an additional line of chemotherapy in the advanced setting.  Datroway® was approved in the US for the same indication in mid-January 2025 and in Japan in December 2024.  However, in December 2024, AZ/Daiichi voluntarily withdrew their European marketing authorisation application for the NSCLC indication of Datroway® based on CHMP feedback.  Daiichi Sankyo and AstraZeneca are jointly developing and commercialising the product pursuant to an agreement entered in July 2020, with Daiichi being the sponsor in Europe.

Pfizer’s Tivdak® (tisotumab vedotin) also received a positive opinion at the January CHMP meeting for treatment of adult patients with recurrent or metastatic cervical cancer with disease progression on or after systemic therapy.

The eight CHMP-recommended indication expansions included those for AZ’s Imfinzi® (durvalumab), for treatment as monotherapy of adults with limited-stage small cell lung cancer (LS-SCLC) whose disease has not progressed following platinum-based chemoradiation therapy; BMS’ Opdivo® (nivolumab) in combination with Yervoy® (ipilimumab) for first line treatment of adult patients with unresectable or advanced hepatocellular carcinoma; and Roche’s Ronapreve® (casirivimab/imdevimab) for COVID-19 in children.

Three biosimilars received positive opinions from CHMP at the January meeting as reported here.

On 30 January 2025, Amgen’s Pavblu® and Skojoy®, biosimilars to Regeneron/Bayer’s Eylea® (aflibercept), received positive recommendations for marketing approval from the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP).  The two biosimilars are indicated for nAMD and visual impairment due to: macular oedema secondary to retinal vein occlusion (branch RVO or central RVO), diabetic macular oedema (DME) and myopic choroidal neovascularisation (myopic CNV).

Amgen’s Pavblu® was the first aflibercept biosimilar to be launched in the US in October 2024, following the Court of Appeals for the Federal Circuit’s denial of Regeneron’s application for an injunction against Amgen.

There are four aflibercept biosimilars already approved (but not yet launched) in the EU: Biocon’s Yesafili® (September 2023), Sandoz’s Afqlir® (November 2024), Samsung Bioepis/Biogen’s Opuviz™ (SB15) (November 2024) and Formycon/Klinge’s FYB203/Baiama®/Ahzantive® (January 2025).  Celltrion’s Eydenzelt®/CT-P42 (aflibercept) received a positive opinion at the CHMP’s December 2024 meeting, while Alvotech/Advanz Pharma and Altos Biologics have submitted MAA’s to the EMA for aflibercept biosimilars.

At its January 2025 meeting, the CHMP also provided good news for CuraTeQ, adopting a positive opinion for its Dyrupeg®, biosimilar to Amgen’s Neulasta® (pegfilgrastim) for the treatment of neutropenia.  This comes over 6 years after the approval of the first European pegfilgrastim biosimilar, Accord Healthcare’s Pelgraz®, in September 2018.

On 29 January 2025, the Australian Therapeutic Goods Administration (TGA) approved Pfizer’s Hympavzi™ (marstacimab) in 150mg/mL solution for injection, prefilled pen, indicated for routine prophylaxis of bleeding episodes in patients 12 years of age and older with: severe haemophilia A without factor VIII inhibitors, or severe haemophilia B without factor IX inhibitors.

Hympavzi™ was approved in the EU and US for the same indication in November 2024 and October 2024, respectively.

On 29 January 2025, the US Court of Appeals for the Federal Circuit refused to overturn preliminary injunctions preventing Samsung Bioepis and Formycon from launching their biosimilars to Regeneron’s Eylea® (aflibercept) in the US without a licence from Regeneron.

In both cases, the Appeals Court affirmed the earlier decisions of the US District Court for the Northern District of West Virginia (dated 14 June 2024 for Samsung Bioepis, and 21 June 2024 for Formycon), finding that Samsung Bioepis and Formycon each infringed, and had failed to raise a substantial question of invalidity of, Regeneron’s US Patent No. 11,084,865 regarding ophthalmic formulations of aflibercept.  It is not known whether the decisions will be appealed to the US Supreme Court.

The BPCIA proceedings were initially commenced by Regeneron against Samsung Bioepis in November and December 2023, and against Formycon in November 2023.  Samsung Bioepis’ aflibercept biosimilar Opuviz™/SB15 received US approval in May 2024, while Formycon’s Ahzantive®/FYB203 was approved June 2024.

The US District Court for the Northern District of West Virginia has also granted a preliminary injunction against Celltrion (June-July 2024), and a permanent injunction against Biocon (11 June 2024), based on findings of infringement of the same patent (US ‘865).  Celltrion lodged an appeal from its preliminary injunction order on 10 July 2024.  Biocon filed a Notice of Appeal from the permanent injunction order on 21 June 2024.  Those appeals are pending.

In October 2024, the Court of Appeals denied Regeneron’s application for an injunction against Amgen.  Amgen launched its aflibercept biosimilar, Pavblu®, in the US later the same month.

Samsung Bioepis, Formycon and Celltrion are challenging Regeneron’s ‘865 patent before the USPTO, each having filed a petition for inter partes review (in November 2024, December 2024 and January 2025, respectively).

On 27 and 28 January 2025, AstraZeneca and Daiichi Sankyo announced that the US FDA has approved Enhertu® (trastuzumab deruxtecan) for the treatment of adult patients with unresectable or metastatic hormone receptor (HR)-positive, HER2-low or HER2-ultralow breast cancer.

The FDA granted priority review to the companies’ supplemental Biologics Licence Application for Enhertu® in October 2024.

Enhertu® will be considered for reimbursement by Australia’s Pharmaceutical Benefits Advisory Committee (PBAC) at its May 2025 meeting.  In December 2024, New Zealand’s Pharmac announced additional funding for Enhertu® for people with HER2-positive metastatic breast cancer.  In November 2024, China added Enhertu® to its state-run health insurance scheme.