Other Updates

On 6 April 2025, ChosunBiz reported that Samsung Bioepis has received approval in South Korea for Obodence™, biosimilar to Amgen’s Prolia® (denosumab).

Obodence™ is Samsung Bioepis’ 10th biosimilar to be approved in South Korea, including following Epyztek® (ustekinumab) in April 2024, Afilivu® (aflibercept) in February 2024, and Episcli® (eculizumab) in January 2024.

Samsung Bioepis’ denosumab biosimilars were approved in February 2025 in both the US (marketed as Ospomyv™/Xbryk™) and Europe (marketed as Obodence™/Xbryk™).  In August 2024, Amgen commenced US BPCIA patent infringement proceedings against Samsung Bioepis in relation to its denosumab biosimilars.  Those proceedings are ongoing.

On 4 April 2025, Sandoz’s Tyruko®, biosimilar to Biogen’s Tysabri® (natalizumab), was approved by Australia’s Therapeutic Goods Administration (TGA).  This is the first biosimilar natalizumab approved in Australia.

Tyruko®’s Australian approval is for a 300mg/15mL concentrate for infusion vial.  It is indicated as monotherapy for the treatment of patients with relapsing remitting multiple sclerosis (MS) to delay the progression of physical disability and to reduce the frequency of relapse.

Australia’s Pharmaceutical Benefits Advisory Committee (PBAC) considered Tyruko® for reimbursement at its March 2025 meeting.  The outcomes of that meeting have not yet been published.

Tyruko® was developed by Polpharma Biologics and, under a global commercialisation agreement with Sandoz reached in 2019, Sandoz has exclusive rights to commercialise and distribute the product in all markets.

Tyruko® is approved in Europe (September 2023) and the US (August 2023).

On 4 April 2025, Celltrion’s denosumab biosimilars, Stoboclo® and Osenvelt®, biosimilars to Amgen’s Prolia® and Xgeva® respectively, were approved by Australia’s Therapeutic Goods Administration (TGA).  Celltrion is the second sponsor to achieve approval of its denosumab biosimilars in Australia, following approval of Sandoz’s Jubbonti® and Wyost® in August 2024.

In December 2024, Sandoz’s denosumab biosimilars were recommended for listing on Australia’s Pharmaceutical Benefits Scheme (PBS).  In November 2024, Amgen secured approvals for 5 new denosumab brands, suggesting that Amgen intends to cannibalise its own denosumab market in Australia.

In May 2024, Amgen licensed generics giant Arrotex to supply Prolia® in Australia.

On 3 April 2025, Celltrion’s Omlyclo®, biosimilar to Genentech/Novartis’ Xolair® (omalizumab), was approved by New Zealand’s Medsafe for the same indications as its reference product.

Omlyclo® is the first omalizumab biosimilar approved in New Zealand.  It was also the first omalizumab biosimilar to be approved in the US (March 2025), Canada (December 2024), Australia (November 2024), the UK (July 2024), South Korea (June 2024), and Europe (May 2024).

Alvotech/Kashiv Biosciences, Aurobindo, Teva and Glenmark are reported to have omalizumab biosimilars under development.

In January 2025, a UK Court denied Celltrion’s application to revoke Genentech/Novartis’ UK omalizumab formulation patent (EP 3805248), finding it was valid and infringed by Celltrion.

On 2 April 2025, Johnson & Johnson announced that the European Commission has approved Stelara® (ustekinumab) for the treatment of moderately to severely active Crohn’s disease in paediatric patients weighing at least 40 kg, who have had an inadequate response to, or were intolerant to either conventional or biologic therapy.

This follows the adoption of a positive opinion by the European Medicine Agency’s Committee for Medicinal Products for Human Use (CHMP) for this indication of Stelara® in February 2025.

There are a number of ustekinumab biosimilars marketed in the EU, with three launched during 2024: STADA/Alvotech’s Uzpruvo® and Sandoz’s Pyzchiva® in July 2024, and Celltrion’s SteQeyma® in November 2024.  Previously approved ustekinumab biosimilars in Europe include Biocon’s Yesintek® (February 2025), Formycon/Fresenius’ Otulfi®/FYB202 (September 2024), Samsung Bioepis’ Eksunbi™ (September 2024) and Amgen’s Wezenla™ (June 2024).

Sandoz’s aflibercept biosimilars, Afqlir® and Enzeevu®, are to be considered for reimbursement by the Pharmaceutical Benefits Advisory Committee (PBAC) at its July 2025 meeting.

The agenda for the PBAC meeting, published on 2 April 2025, lists the two biosimilars to Regeneron/Bayer’s Eylea® for consideration in relation to macular oedema secondary to retinal vein occlusion (RVO), diabetic macular oedema (DMO), and subfoveal choroidal neovascularisation (CNV) secondary to age-related macular degeneration (AMD).

Sandoz’s aflibercept biosimilars are not yet ARTG listed, unlike Celltrion’s aflibercept biosimilar, Eydenzelt®, which was the first biosimilar aflibercept approved on 31 March 2025.  However, Sandoz’s aflibercept biosimilars will be the first to be considered by PBAC for reimbursement, indicating that Sandoz will likely be the first to launch in Australia.

On 1 April 2025, Eisai reported that the final process for the European Commission (EC) regulatory review of Eisai’s Marketing Authorisation Application (MAA) for Leqembi® (lecanemab) as a treatment for early Alzheimer’s disease (AD) is underway.

In February 2025, Biogen and Eisai announced that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) reaffirmed its positive opinion for Leqembi® for early Alzheimer’s disease.  The EC has deliberated on the MAA in its Standing Committee and has now referred the decision to the Appeal Committee in accordance with the EC review process.

Leqembi® has 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 Brazil, Canada, India, Russia, Taiwan, Singapore, and Switzerland.  Australia’s Therapeutic Goods Administration (TGA) declined to approve Leqembi® (lecanemab) for the treatment of early Alzheimer’s Disease.

On 1 April 2025, the European Medicines Agency (EMA) published a draft reflection paper questioning whether biosimilars may be approved in future without submission of Comparative Efficacy Studies (CES).  The EMA considers that “[w]aiving certain clinical data requirements would simplify the development and evaluation process” of biosimilars “while maintaining the highest standards of safety and efficacy”.

According to the EMA, advances in analytical characterisation, and its extensive regulatory experience in approving significant changes in manufacturing processes of biological medicines by confirmation of structural and functional comparability, “supports the notion that under specific prerequisites, analytical comparability exercises and pharmacokinetic (PK) data could be sufficient for demonstrating biosimiliarity”.  The EMA also refers to its experience indicating that the results from CES in the past “generally did not add relevant additional information to the biosimilarity exercise”.

The reflection paper concludes that CES may no longer be required for approval of biosimilars “if similar clinical efficacy and safety pharmacology can be inferred from a sufficiently stringent evaluation of analytical comparability, in vitro pharmacology, and a comparative clinical PK trial”.

The EMA is inviting stakeholders to send their comments on the reflection paper via an online EU Survey until 30 September 2025.

On 1 April 2025, Organon announced that it has acquired from Biogen the US regulatory and commercial rights to Tofidence™, biosimilar to Roche’s Actemra® (tocilizumab).  Product developer Bio-Thera Solutions will continue to manufacture the product.

Tofidence™ was the first US approved tocilizumab biosimilar (IV formulation, September 2023), followed by Fresenius Kabi’s Tyenne® (SC formulation, March 2024) and Celltrion’s Avtozma® (IV and SC formulations, February 2025).

Korea Biomedical Review reported on 31 March 2025 that Celltrion has received a positive opinion from the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) regarding its autoinjector formulation of Omlyclo®, biosimilar to Genentech/Novartis’ Xolair® (omalizumab).  The injector formulation will be supplied in 75mg and 150mg doses.

Celltrion’s omalizumab biosimilar was approved (in pre-filled syringe) in the US in March 2025, Canada in December 2024, Australia in November 2024, the UK in July 2024, Korea in June 2024 and Europe in May 2024.