On 26 and 27 January 2025, Eisai and Biogen announced that the US FDA has approved Leqembi® (lecanemab-irmb) IV maintenance dosing for the treatment of Alzheimer’s disease in patients with mild cognitive impairment (MCI) or mild dementia stage of disease.  The sBLA for monthly Leqembi® IV maintenance dosing had been accepted by the FDA in June 2024.

This news comes two weeks after the US FDA accepted Eisai/Biogen’s Biologics Licence Application for Leqembi® subcutaneous autoinjector for weekly maintenance dosing for the same indication.

Leqembi® is approved for MCI and Early Alzheimer’s disease in the UK, US, Japan, China, South Korea, Mexico, Hong Kong and Israel, and the UAE.  In November 2024, the product received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency.  Earlier announcements made by Eisai note that applications are under review in Brazil, Canada, India, Russia, Taiwan, Singapore, Saudi Arabia and Switzerland.  In October 2024, Australia’s Therapeutic Goods Administration (TGA) declined to approve Leqembi® due to safety and efficacy concerns.

On 27 January 2025, Alvotech and Teva Pharmaceuticals announced that the US FDA has accepted for review their Biologics Licence Applications for AVT05, biosimilar to Johnson & Johnson’s Simponi® and Simponi Aria® (golimumab), which are indicated for a variety of chronic inflammatory diseases.  This is the first BLA filing acceptance for biosimilar golimumab in the US.

Alvotech/Advanz Pharma’s marketing authorisation application (MAA) for AVT05 was accepted by the European Medicines Agency in November 2024.  This was the first golimumab biosimilar MAA to be filed and accepted anywhere in the world.

Alvotech expects the approvals process in both the EU and the US to be completed in Q4 2025.

AVT05 is being commercialised in the US by Teva pursuant to a strategic partnership entered into with Alvotech in August 2020.  In May 2023, Alvotech and Advanz Pharma entered into a master licence and supply agreement to commercialise and supply AVT05 in Europe.

On 24 January 2025, CSL announced that the Australian Therapeutic Goods Administration (TGA) has approved Andembry® (garadacimab) for routine prevention of recurrent hereditary angioedema (HAE) attacks in patients 12 years and older with C1 esterase inhibitor deficiency or dysfunction.  The regulatory approval for registration in Australia is the first in the world for Andembry®.

Andembry® was recommended by the Pharmaceutical Benefits Advisory Committee (PBAC) for funding on Australia’s Pharmaceutical Benefits Scheme (PBS) at its November 2024 meeting.

It received a positive opinion in December 2024 from the European Medicine Agency’s CHMP and is currently under review by the US FDA, with CSL’s Biologics Licence Application (BLA) for Andembry® (previously referred to as CSL312) accepted in December 2023.

On 24 January 2025, Amgen announced that it has settled its patent infringement litigation against Celltrion in the US District Court for the State of New Jersey, relating to Celltrion’s biosimilar denosumab.

Amgen had commenced proceedings against Celltrion in May 2024, alleging infringement of 29 patents relating to denosumab.  The allegations followed Celltrion’s abbreviated Biologics Licence Application (aBLA) submitted in December 2023 for CT-P41, its biosimilar to Amgen’s Xgeva® and Prolia® (denosumab).

Pursuant to the settlement agreement, the parties consented to the Court making an order that the asserted claims of the 29 patents in suit are valid, enforceable and infringed by the exploitation of Celltrion’s biosimilar products in the US.  The Court further granted an injunction, by consent, preventing it from making or selling its biosimilar denosumab in the US, except as permitted by the confidential settlement agreement.

The injunction expires on 1 June 2025, permitting Celltrion to launch its denosumab products in the US from that date.

The proceeding against Celltrion was one of five that Amgen had commenced in the US in relation to denosumab biosimilars.  A dispute with Sandoz, commenced in May 2023, was resolved in April 2024, enabling Sandoz to launch its denosumab biosimilars, Jubbonti® and Wyost®, from 31 May 2025 (or earlier in certain undisclosed circumstances).  The remaining court proceedings, against Fresenius Kabi (FKS518/commenced October 2024), Samsung Bioepis (SB16/commenced August 2024) and Accord/Intas (INTP23/commenced November 2024), remain pending.

Sandoz’s Wyost® and Jubbonti® were the first denosumab biosimilars approved in the US in March 2024.  No other denosumab biosimilars have been approved in the US to date, although Gedeon Richter/Hikma (December 2024), Organon/Shanghai Henlius (October 2024), Teva (October 2024), and Fresenius Kabi (May 2024) have each had Biologics Licence Applications accepted for review by the FDA.

Celltrion’s Osenvelt®/CT-P41, biosimilar to Amgen’s Xgeva®, and Stoboclo®/CT-P41, biosimilar to Amgen’s Prolia®, received positive opinions from the EMA’s CHMP in December 2024.

On 23 January 2025, Celltrion confirmed that it has completed the launch of Steqeyma®/CT-P43, biosimilar to J&J/Janssen’s Stelara® (ustekinumab), in France, Italy, Spain, the UK, and Germany.

Steqeyma® was launched in France on 20 January 2025, Italy and Spain in mid-January 2025, the UK on 2 December 2024, and Germany in November 2024.

Celltrion was 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.  This was quickly followed by Sandoz announcing the European launch of Pyzchiva® on 25 July 2024.

Steqeyma® was approved in Europe in August 2024, following a positive CHMP opinion in June 2024.  It received approval in the UK in September 2024.

On 17 December 2024, Celltrion announced that the US FDA had approved Steqeyma®.  According to Celltrion it is in the planning stages for the US launch of the product.

On 22 January 2025, Samsung Biologics revealed its Q4 and 2024 annual financial results, reporting full year 2024 consolidated revenue of over 4 trillion won (approx. USD2.78bn), a 23% increase compared to 2023.  According to the Korea Herald, this makes Samsung Biologics the first biotech company in South Korea to reach this sales milestone.

Samsung Biologics’ Q2/24 consolidated revenue was KRW 1.26 trillion, with operating profit of KRW 325.7 billion.

Samsung Biologic’s biosimilar subsidiary, Samsung Bioepis, achieved 2024 consolidated revenue of 1.537 trillion won, a 51% increase year on year.  Its operating profit more than doubled compared to 2024, at 435 billion won.

Biosimilar highlights for 2024 are reported to include the European launch (July 2024) and US FDA approval (July 2024) of SB17/Pyzchiva® (ustekinumab, biosimilar to J&J/Janssen’s Stelara®), the US approval (July 2024) of SB12/Epysqli™ (eculizumab, biosimilar to Alexion’s Soliris®), the European (November 2024) and US FDA approval (May 2024) of SB15/Opuviz® (aflibercept, biosimilar to Regeneron’s Eylea®), and the positive CHMP opinion (November 2024) for SB16/Obodence®/Xbryk® (denosumab, biosimilar to Amgen’s Prolia® and Xgeva®).

On 22 January 2025, Sanofi announced that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has approved Sarclisa® (isatuximab) in combination with a standard-of-care regimen, bortezomib, lenalidomide, and dexamethasone (VRd), for the treatment of adult patients with newly diagnosed multiple myeloma (NDMM) ineligible for autologous stem cell transplant (ASCT).

This news follows the CHMP’s positive recommendation (November 2024) and US FDA approval (September 2024) for the same combination therapy and indication.  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 22 January 2025, Johnson & Johnson (J&J) reported its results for Q4 2024, which saw sales growth of 5.3% to $22.5B.

On the same day, Genmab announced that worldwide annual net sales of Darzalex® (daratumumab) for 2024, as reported by J&J, totalled USD11.7 billion.  US sales accounted for more than half of this total, reaching USD6.6 billion.  Genmab receives royalties on the worldwide net sales of Darzalex® (IV and SC), under its exclusive worldwide licence to Janssen to develop, manufacture and commercialise daratumumab.

J&J reports that it achieved several significant regulatory milestones in Q4 2024 across the EU and US.  This includes the European approval for several new indications of J&J biologics, such as Darzalex® SC based quadruplet regimen for multiple myeloma (October 2024), and Rybrevant® (amivantamab) in combination with Lazcluze® (lazertinib) for non-small cell lung cancer (December 2024).  J&J also submitted an application in the EU for approval of Darzalex® SC for high-risk smouldering multiple myeloma (November 2024).

In the US, J&J submitted an application for approval of a new indication of Darzalex Faspro® (daratumumab and hyaluronidase-hj) for high-risk smouldering multiple myeloma (November 2024), and received Breakthrough Therapy designation (BTD) for nipocalimab for the treatment of adults living with moderate-to-severe Sjögren’s disease (November 2024).  J&J also sought FDA approval for a subcutaneous induction regimen of Tremfya® (guselkumab) for ulcerative colitis (November 2024).

On 20 January 2025, Roche announced that Health Canada has approved its Vabysmo® (faricimab) 6.0 mg single-use pre-filled syringe (PFS) for use in the treatment of nAMD, diabetic macular oedema (DME) and macular oedema secondary to retinal vein occlusion (RVO).  Vabysmo® PFS delivers the same dose as the currently available 6.0 mg vial formulation, and, according to Roche, will become available to Canadian ophthalmologists and their patients in the coming months.

Vabysmo® was first approved by Health Canada for nAMD and DME in June 2022, and for RVO in July 2024.  This news follows EU approval for Vabysmo® PFS for the same indications in December 2024, and in the US in July 2024.

On 20 January 2025, Korea Biomedical Review reported that, at the JP Morgan Healthcare Conference on 14 January 2025, Celltrion revealed its plans to launch CT-P41, biosimilar to Amgen’s Prolia® (denosumab) in the US, Europe and Japan in 2025, at a significant discount for the prevention of osteoporosis as well as its treatment.

Celltrion filed an abbreviated Biologics Licence Application for CT-P41 in the US in December 2023.  However, in May 2024, Celltrion was sued by Amgen in the District Court of New Jersey for alleged infringement of 29 patents regarding denosumab.  That litigation remains pending as at the date of Celltrion’s announcement at the JP Morgan Conference.

Celltrion’s Osenvelt®/CT-P41, biosimilar to Amgen’s Xgeva® (denosumab), and Stoboclo®/CT-P41, biosimilar to Amgen’s Prolia® (denosumab), received positive opinions from the EMA’s CHMP in December 2024.

According to KBM, at the JP Morgan Conference, Celltrion’s Chairman also revealed that the company plans to launch four other biosimilars in the US, EU and Japan in 2025: ustekinumab/Steqeyma®/CT-P43 (already launched in Europe in November 2024, approved in US in December 2024); aflibercept/Eydenzelt™/CT-P42 (NDA filed with the FDA in June 2023, positive CHMP opinion received from the European Medicines Agency in December 2024); tocilizumab/Avtozma®/CT-P47 (positive CHMP opinion received in December 2024; BLA submitted in the US in January 2024); omalizumab/Omlyclo®/CT-P39 (approved in Europe (May 2024) and aBLA submitted in the US in March 2024).