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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.

Teva/Samsung Bioepis Launch Epysqli® (Eculizumab-aagh) in US

Apr 7, 2025

On 7 April 2025, Teva and Samsung Bioepis announced the US launch of Epysqli® (eculizumab-aagh), biosimilar to Alexion’s Soliris®. According to the joint announcement, Epysqli® will be offered at a 30% discount of the Wholesale Acquisition Cost (WAC) of Soliris®.

This makes Epysqli® the second available eculizumab biosimilar in the US, following the launch of Amgen’s Bkemv® (eculizumab-aeeb) in March 2025. The timing of the US launch of Bkemv® was governed by a settlement reached by Amgen and Alexion in May 2020, permitting launch from 1 March 2025.

Epysqli® was launched in Germany, Italy and Spain in October 2023 and in Korea in April 2024. The UPC (June/July 2024) and the UPC Court of Appeal (December 2024) refused to grant preliminary injunctions against Samsung Bioepis and Amgen in relation to the sale of their eculizumab biosimilars in the EU.

EC Approves Expanded Multiple Myeloma Indication for J&J’s Darzalex® (Daratumumab) Quadruplet Regimen

Apr 7, 2025

On 7 April 2025, 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) regardless of transplant eligibility. The indication expansion was recommended by the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) in February this year.

The EC approved the same indication in October 2024, however, only for patients who are eligible for an autologous stem cell transplant (ASCT). The new approval removes that limitation.

There are a number of daratumumab biosimilars currently under development. In February 2025, Shanghai Henlius announced that it has entered into a licence agreement with Dr. Reddy’s for HLX15, biosimilar to Darzalex® and Darzalex Faspro® (daratumumab and hyaluronidase-fihi). In December 2024, Celltrion announced that the US FDA approved its Investigational New Drug (IND) application for a global Phase 3 clinical trial of its daratumumab biosimilar, CT-P44, which followed its European IND submission and entry into the global phase 3 trial procedure in November 2024.

Approval Alert: Samsung Bioepis’ Denosumab Biosimilar Approved in South Korea

Apr 6, 2025

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.

Approval Alert: Amgen’s Biosimilar Aflibercept Approved in EU

Apr 4, 2025

On 4 April 2025, the European Commission granted marketing authorisation to Amgen’s Pavblu® (aflibercept 2mg), biosimilar to Bayer/Regeneron’s Eylea® for nAMD and visual impairment due to: macular oedema secondary to retinal vein occlusion (RVO), diabetic macular oedema (DME) or myopic choroidal neovascularisation (CNV).

Pavblu®, together with a second Amgen aflibercept biosimilar Skojoy® (for which the marketing application was withdrawn on 4 March 2025), received positive recommendations for marketing approval from the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) in January 2025.

Pavblu® is the seventh aflibercept biosimilar approved in Europe following: Celltrion’s Eydenzelt® (February 2025), Biocon’s Yesafili® (September 2023), Sandoz’s Afqlir® (November 2024), Samsung Bioepis/Biogen’s Opuviz™ (SB15) (November 2024) and Formycon/Klinge’s Baiama® and Ahzantive® (January 2025).

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’s launch of the product.

The first bevacizumab biosimilar approved in the US was Amgen’s Mvasi® in September 2017. There are four other bevacizumab biosimilars FDA approved: Pfizer’s Zirabev® (June 2019), Amneal’s Alymsys® (April 2022), Celltrion’s Vegzelma™ (September 2022), and Bio-Thera/Sandoz’s Avzivi® (December 2023).

Approval Alert: Sandoz’s Tyruko® is First Natalizumab Biosimilar Approved in Australia

Apr 4, 2025

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).

Approval Alert: Celltrion’s Denosumab Biosimilars AU Approved

Apr 4, 2025

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.

Approval Alert: Celltrion’s Omlyclo® is First Omalizumab Biosimilar Approved in NZ

Apr 3, 2025

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.

New Indication Alert: J&J’s Stelara® (Ustekinumab) EU Approved for Paediatric Use in Crohn’s Disease

Apr 2, 2025

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 on Australia’s July PBAC Agenda

Apr 2, 2025

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.

Pearce IP BioBlast® for the week ending 28 March 2025

Apr 1, 2025

Pearce IP provides weekly reports on global biosimilars activities in the Pearce IP BioBlast®. Significant biosimilar activities for the week ending 28 March 2025 are set out below:

Denosumab

26 March 2025 | US | Approval Alert: FDA Approves Denosumab Biosimilars for Fourth Sponsor

On 26 March 2025, Fresenius Kabi announced that the US FDA approved its Biologics Licence Application (BLA) for Conexxence® and Bomyntra® (denosumab-bhnt), biosimilars to Amgen’s… Read more here.

Denosumab, Ustekinumab

27 March 2025 | EU | Positive Opinions for Accord’s Denosumab and Celltrion’s Ustekinumab Biosimilars in EU

At its March 2025 meeting, the European Medicine Agency’s Committee for Medicinal Products for Human Use (CHMP) adopted positive opinions for three new biosimilars… Read more here.

Golimumab, Ustekinumab

26 March 2025 | ASIA | Bio-Thera and Dr Reddy’s Enter SE Asia Commercialisation Agreement for Golimumab and Ustekinumab Biosimilars

On 26 March 2025, Bio-Thera Solutions and Dr Reddy’s announced that they have entered exclusive commercialisation and licence agreements for BAT2206 and BAT2506, biosimilars to J&J/Janssen’s… Read more here.

Mepolizumab

24 March 2025 | EU | EMA Accepts GSK’s Mepolizumab Indication Expansion Application for COPD

On 24 March 2025, GSK announced that the European Medicines Agency (EMA) has accepted for review its application to expand the use of Nucala® (mepolizumab) as an add-on maintenance… Read more here.

Ocrelizumab

27 March 2025 | AU | Roche’s Subcutaneous Ocrelizumab Registered in Australia

Omalizumab

26 March 2025 | UK | Alvotech/Kashiv/Advanz’s Omalizumab Biosimilar MAA Accepted in UK

On 26 March 2025, Alvotech, Kashiv Biosciences and Advanz Pharma announced that the UK Medicines and Healthcare Products Regulatory Agency (MHRA) has accepted its application for marketing authorisation (MAA) for AVT23… Read more here.

Pembrolizumab

27 March 2025 | US | FDA Accepts Merck/MSD’s BLA for SC Pembrolizumab; Decision Expected September 2025

Pertuzumab

28 March 2025 | EU | EMA Accepts Henlius/Organon’s MAA for Biosimilar Pertuzumab

On 28 March 2025, Shanghai Henlius Biotech, Inc. and Organon announced that the European Medicines Agency (EMA) has validated their marketing authorisation application (MAA) for HLX11… Read more here.

Tocilizumab

27 March 2025 | EU | EMA Accepts Gedeon Richter’s Application for Biosimilar Tocilizumab

On 27 March 2025, Gedeon Richter announced that the European Medicines Agency (EMA) has accepted its marketing authorisation application (MAA) for RGB-19, biosimilar to Roche’s… 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 Attorney (AU, NZ) & Trade Mark Attorney (AU)

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.

Nathan Kan

Graduate (Law)

Nathan is a Graduate (Law) focused on providing legal services and advice to life sciences clients, with a focus on litigation support regarding intellectual property (patents, trade marks, designs, copyright, domain names, plant breeders rights and confidential information) and commercial disputes.

Nathan is passionate about the intersection of law and science. Whilst serving as Sponsorship Director and subsequently as Vice President of the Science and Technology Law Association (SATLA) at the University of Melbourne, he led various engagement events, workshops and publications covering a range of STEM fields, including life sciences, artificial intelligence and digital transformation.

Leqembi® (Lecanemab-irmb) European Update

Apr 1, 2025

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.

EMA Reconsiders Need for Biosimilar Comparative Efficacy Studies; Invites Stakeholder Comments

Apr 1, 2025

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.

Organon Acquires US Rights to Biogen’s Tocilizumab Biosimilar

Apr 1, 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).

Positive CHMP Opinion for Celltrion’s Omalizumab Autoinjector

Mar 31, 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.

Approval Alert: Celltrion’s Eydenzelt® First Aflibercept Biosimilar AU Approved

Mar 31, 2025

On 31 March 2025, Celltrion’s Eydenzelt® (CT-P42), biosimilar to Regeneron/Bayer’s Eylea® (aflibercept), was approved by Australia’s Therapeutic Good’s Administration (TGA) as follows:

40 mg/mL solution for intravitreal injection pre-filled syringe (431931); and
40 mg/mL solution for intravitreal injection vial with needle (431932).

Eydenzelt® is indicated for the treatment of visual impairment due to myopic choroidal neovascularisation (myopic CNV).

Eydenzelt® is the first aflibercept biosimilar approved in Australia. It has recently been approved in Europe (February 2025) for the treatment of multiple retinal disorders, including nAMD, macular oedema following retinal vein occlusion (RVO), diabetic macular oedema (DME) and myopic choroidal neovascularisation (myopic CNV). Celltrion filed a US NDA in June 2023 for Eydenzelt® and received Korean approval in May 2024.

AZ’s Imfinzi® (durvalumab) US-Approved for Muscle Invasive Bladder Cancer

Mar 28, 2025

On 28 March 2025, the US FDA approved AstraZeneca’s Imfinzi® (durvalumab) with gemcitabine and cisplatin as neoadjuvant treatment, followed by single agent durvalumab as adjuvant treatment following radical cystectomy, for adults with muscle invasive bladder cancer (MIBC).

AstraZeneca’s sBLA for Imfinzi® for the MIBC indication was granted priority review by the FDA in December 2024. In February 2025, Australia’s TGA accepted for review an indication expansion of Imfinzi® for MIBC.

EMA Accepts Henlius/Organon’s MAA for Biosimilar Pertuzumab

Mar 28, 2025

Henlius/Organon have previously had applications for HLX11 accepted by the US FDA (February 2025) and China’s Center for Drug Evaluation of the National Medical Products Administration (December 2024).

In June 2022, Henlius entered into a licence agreement with Organon regarding HLX11 (and HLX14), under which Organon has exclusive global commercialisation rights to the biosimilars for all countries except China, Hong Kong, Macau and Taiwan.

Roche’s Subcutaneous Ocrelizumab Registered in Australia

Mar 27, 2025

On 27 March 2025, Roche’s subcutaneous Ocrevus® (ocrelizumab) was listed on the Australian Register of Therapeutic Goods (ARTG). This adds to the intravenous formulation of Ocrevus® listed on the ARTG in July 2017. Both formulations are indicated for the treatment of patients with primary progressive and relapsing forms of multiple sclerosis.

In January 2025, at the JP Morgan Annual Healthcare conference, Amgen revealed that it currently has an ocrelizumab biosimilar (ABP 692) undergoing Phase 3 trials. Celltrion also has an ocrelizumab biosimilar in development, announcing in August 2023 that the European Medicines Agency (EMA) had partially approved its Phase 3 IND for CT-P53 (ocrelizumab).

Edited by Pearce IP on 3 April 2025.

New Indication Alert: Chugai/Zenyaku’s Rituximab Approved in Japan for Nephrotic Syndrome

Mar 27, 2025

On 27 March 2025, Chugai (a Roche subsidiary) and Zenyaku Kogyo announced that their co-marketed Rituxan® (rituximab) has been approved by the Japanese Ministry of Health, Labour and Welfare for “frequently relapsing or steroid-dependent nephrotic syndrome” in childhood (IV injection, 100mg and 500mg) that has not yet become intractable.

Rituxan® was approved in Japan in November 2024 for chronic idiopathic thrombocytopenic purpura (ITP) in children. Prior to this, Rituxan® had only been approved in Japan for chronic ITP in adults.

Rituximab was one of the first mAbs to become “biosimilar”. Both Pfizer and Sandoz/Kyowa Kirin market rituximab biosimilars in Japan. There are three rituximab biosimilars currently on the US market: Teva and Celltrion’s Truxima® (launched in May 2020), Pfizer’s Rituxience® (launched in January 2020) and Amgen and Allergan’s Riabni^TM (approved by the FDA in December 2020).

CHMP Recommends Indication Expansions for BMS’ Opdivo®, Janssen’s Tremfya® and Beigene’s Tevimbra®

Mar 27, 2025

At its March meeting, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted positive opinions for seven indication expansions, including to:

BMS’ Opdivo® (nivolumab) in combination with platinum-based chemotherapy as neoadjuvant treatment, followed by Opdivo® as monotherapy as adjuvant treatment, for the treatment of resectable non-small cell lung cancer (NSCLC) at high risk of recurrence in adult patients whose tumours have PD-L1 expression at or higher than 1%.
Janssen’s Tremfya® (guselkumab) for treatment of adults with moderately to severely active Crohn’s disease who have had an inadequate response, lost response, or were intolerant to either conventional therapy or a biologic treatment; and
Beigene’s Tevimbra® (tislelizumab) in combination with etoposide and platinum chemotherapy, for first-line treatment of adults with extensive-stage SCLC.

The CHMP also recommended the approval of a new Opdivo® formulation associated with a new route of administration (subcutaneous use), a new pharmaceutical form (solution for injection) and a new strength (600 mg/vial). Subcutaneous Opdivo® has previously been approved in the US for most but not all previously approved adult, solid tumour indications.

EMA Accepts Gedeon Richter’s Application for Biosimilar Tocilizumab

Mar 27, 2025

On 27 March 2025, Gedeon Richter announced that the European Medicines Agency (EMA) has accepted its marketing authorisation application (MAA) for RGB-19, biosimilar to Roche’s RoActemra® (tocilizumab). This follows Gedeon’s announcement of positive topline results from Phase 1 and Phase 3 clinical studies for RGB-19 in January 2025, both of which met their primary endpoints.

RGB-19 was co-developed by Mochida and Gedeon Richter. Mochida will file marketing authorisation applications for RGB-19 in Japan, while Richter will do so in major global markets outside Japan.

In February 2025, Celltrion’s Avtozma® became the third tocilizumab biosimilar approved in the EU, following Fresenius Kabi’s Tyenne®, in both IV and SC forms, in November 2023, and Biogen’s IV Tofidence™, in June 2024.

FDA Accepts Merck/MSD’s BLA for SC Pembrolizumab; Decision Expected September 2025

Mar 27, 2025

On 27 March 2025, Merck (known as MSD outside the US and Canada) announced that the US FDA has accepted its Biologics Licence Application for subcutaneous pembrolizumab (pembrolizumab plus berahyaluronidase alfa), with indications across all previously approved solid tumour indications for Keytruda®. The FDA has set a PDUFA, or target action, date of 23 September 2025.

Reuters has reported that Merck/MSD intends to launch SC pembrolizumab on 1 October 2025. This aligns with Merck/MSD’s previously expressed expectations of a 2025 launch for the subcutaneous product.

According to Merck/MSD, the European Medicines Agency (EMA) has also validated an extension application to introduce a new pharmaceutical form and new route of administration for Keytruda®.

Positive Opinions for Accord’s Denosumab and Celltrion’s Ustekinumab Biosimilars in EU

Mar 27, 2025

At its March 2025 meeting, the European Medicine Agency’s Committee for Medicinal Products for Human Use (CHMP) adopted positive opinions for three new biosimilars.

Accord Healthcare’s Jubereq® and Osvyrti®, biosimilars to Amgen’s Xgeva® and Prolia® (denosumab) respectively, have received recommendations for the same indications as the reference products.

In addition, the CHMP has recommended Celltrion’s Qoyvolma®, biosimilar to J&J/Janssen’s Stelara® (ustekinumab) for the treatment of moderate to severe plaque psoriasis in adults who failed to respond to, or who have a contraindication to, or are intolerant to other systemic therapies.

To date, there have been three sponsors with denosumab biosimilars approved in Europe: Celltrion’s Stoboclo®/Ozenvelt® (February 2025), Samsung Bioepis’ Obodence™ and Xbryk™ (February 2025), and Sandoz’s Wyost® and Jubbonti® (May 2024). The EMA has accepted MAAs for a number of other denosumab biosimilars including for STADA/Alvotech (AVT03, October 2024), Teva (TVB-009P, October 2024), Gedeon Richter (July 2024), Fresenius Kabi (FKS518, July 2024), and Shanghai Henlius/Organon (HLX14, May 2024).

There are a number of ustekinumab biosimilars being 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).

Celltrion’s Biosimilar Ustekinumab to be Supplied in the US by Costco

Mar 27, 2025

On 27 March 2025, Celltrion announced that its Steqeyma®, biosimilar to J&J’s Stelara® (ustekinumab), has been added to the US Costco Member Prescription Program. Steqeyma® will be available from US Costco Specialty Pharmacies from 1 April 2025 for self-funded employer plans and Costco members who are uninsured and want to pay cash for their Steqeyma® prescription or who have been denied coverage by their insurers. According to Celltrion, the wholesale acquisition cost (WAC) for Steqeyma® will be discounted by 85% compared with the current US WAC list price of Stelara®.

Steqeyma® was launched in the US in March 2025 for the treatment of psoriatic arthritis, plaque psoriasis, Crohn’s disease, ulcerative colitis, paediatric plaque psoriasis and paediatric psoriatic arthritis.

In August 2024, Celltrion also announced the addition of adalimumab-aaty, biosimilar to AbbVie’s Humira®, to the Costco Member Prescription Program.