Shots:       

• Biosimilars are developed to be highly similar versions of approved biologics in terms of safety, purity, and potency        

• Biosimilars are expected to be a cost-effective alternative to the high-priced branded biologics, offering significant and much-needed cost savings to both payers and patients        

• Bio-Thera Collaborates with Dr. Reddy’s for the Commercialization of BAT2206 & BAT2506 in Southeast Asia. Our team at PharmaShots has summarized 13 key events of the biosimilar space of March 2025 

1. Fresenius Kabi Launches Otulfi (Biosimilar, Stelara) in the US 

Company: Fresenius Kabi 

Product: Otulfi 

Active Ingredient: Ustekinumab- aauz 

Reference Product: Stelara 

Reference Product Company: Johnson & Johnson 

Disease: Psoriatic Arthritis, Plaque Psoriasis, Crohn’s Disease, Ulcerative Colitis, and Pediatric Plaque Psoriasis & Psoriatic Arthritis 

Date: Mar 03, 2025   

Shots: 

• Fresenius Kabi has launched Otulfi (ustekinumab- aauz) injection, a biosimilar to Stelara, developed by Formycon AG to treat mod. to sev. Crohn’s disease, ulcerative colitis, and plaque psoriasis & active psoriatic arthritis (age ≥ 6 yrs.) across the US 

• Otulfi will be available in the US in 45 mg/0.5 mL and 90 mg/mL prefilled syringes for injection, and a 130 mg/26 mL vial for IV. A 45 mg/0.5 mL single-dose vial for SC is expected to receive FDA approval in H1’25  

• In February 2023, Fresenius Kabi and Formycon formed a global partnership to commercialize ustekinumab biosimilar, which received FDA approval in September 2024 

2. Celltrion Reports the US FDA approval for Stoboclo & Osenvelt (Biosimilars, Prolia & Xgeva) 

Company: Celltrion 

Product: Stoboclo & Osenvelt 

Active Ingredient: Denosumab-bmwo & Denosumab-bmwo 

Reference Product: Prolia & Xgeva 

Reference Product Company: Amgen 

Disease: Osteoporosis & Prevention of Skeletal Related Events 

Date: Mar 04, 2025   

Shots: 

• The US FDA has approved Stoboclo & Osenvelt (CT-P41, denosumab), a biosimilar to Prolia & Xgeva for all indications of the reference products 

• Approval is based on P-III trial results in postmenopausal women with osteoporosis, which showed equivalent efficacy & PD of CT-P41 to reference denosumab, with similar PK and comparable safety, and immune response 

• As part of a settlement with Amgen, STOBOCLO and OSENVELT are anticipated to launch in the US market in June 2025 

3. Biocon Biologics Report the P-III Study Positive Results of Yesintek (Biosimilar, Stelara) 

Company: Biocon Biologics 

Product: Yesintek 

Active Ingredient: Ustekinumab 

Reference Product: Stelara 

Reference Product Company: Johnson & Johnson 

Disease: Psoriatic Arthritis, Plaque Psoriasis, Crohn’s Disease, Ulcerative Colitis, and Pediatric Plaque Psoriasis & Psoriatic Arthritis 

Date: Mar 07, 2025   

Shots: 

• Biocon Biologics revealed positive results from the P-III study demonstrating that Yesintek achieved equivalent efficacy, safety, immunogenicity, and PK vs reference product to treat mod. to sev. chronic plaque psoriasis (PsO) pts. (n=384, age= 18-80yrs.); data was presented at AAD 2025 

• The primary efficacy endpoint, percentage change in PASI scores at Wk. 12 showed similar improvement, with a mean difference of 0.68%, within predefined equivalence margins of the US FDA & EMA. Switching from Stelara to YESINTEK at Wk. 16 maintained efficacy & safety through Wk. 52 

•  Yesintek (mAb) targets interleukins IL-12 and IL-23, approved for the treatment of Crohn’s disease, Ulcerative Colitis, PsO and Psoriatic Arthritis 

4. Celltrion’s Omlyclo (Biosimilar, Xolair) Secures the US FDA’s Approval 

Company: Celltrion 

Product: Omlyclo 

Active Ingredient: Omalizumab-igec 

Reference Product: Xolair 

Reference Product Company: Roche 

Disease: Mod. To Sev. Persistent Asthma, CRSwNP, IgE-mediated food allergy & Chronic Spontaneous Urticaria  

Date: Mar 09, 2025   

Shots: 

• The US FDA has approved & granted interchangeability designation to Omlyclo, a biosimilar to Xolair (omalizumab) for the treatment of mod. to sev. persistent asthma, CRSwNP, IgE-mediated food allergy, & chronic spontaneous urticaria (CSU) 

• Approval was based on multiple clinical evidence, incl. P-III trial assessing Omlyclo (150mg, Q4W) vs Xolair (300mg, Q4W) in 619 CSU pts for 12wks., followed by re-randomization of comparator arm to Omlyclo or Xolair. From Wk. 24, pts were monitored without dosing until Wk. 40 

• Study demonstrated interchangeability with reference product, showing comparable efficacy & safety during both treatment & off-dose period 

5. Celltrion launches SteQeyma (Biosimilar, Stelara) in the US 

Company: Celltrion 

Product: SteQeyma 

Active Ingredient: Ustekinumab -stba 

Reference Product: Stelara 

Reference Product Company: Johnson & Johnson 

Disease: Psoriatic Arthritis, Plaque Psoriasis, Crohn’s Disease, Ulcerative Colitis, and Pediatric Plaque Psoriasis & Psoriatic Arthritis 

Date: Mar 12, 2025   

Shots: 

• Celltrion has launched SteQeyma (ustekinumab-stba) injection, a biosimilar to Stelara, for all indications of the reference products following the US FDA’s approval in Dec 2024 

• Approval was supported by various clinical evidence incl. P-III trial of SteQeyma vs Stelara for mod. to sev. plaque PsO, with 1EP as rate of change in the PASI for skin symptoms, showing similar safety & efficacy b/w both the drugs 

• SteQeyma, a human IL-12 & IL-23 antagonist, is available as SC injection (45mg/0.5mL or 90mg/1mL in a single-dose, prefilled syringes) & IV infusion (130mg/26mL solution in a single-dose vial) at an 85% discount to Stelara’s WAC price 

6. Alvotech and Dr. Reddy’s Report the US FDA’s BLA Acceptance for AVT03 (Biosimilar, Prolia and Xgeva) 

Company: Alvotech and Dr. Reddy’s 

Product: AVT03 

Active Ingredient: Denosumab 

Reference Product: Prolia & Xgeva 

Reference Product Company: Amgen 

Disease: Osteoporosis & Prevention of Skeletal Related Events 

Date: Mar 18, 2025   

Shots: 

• The US FDA has accepted 351(k) BLA of AVT03, a biosimilar version of Prolia & Xgeva (denosumab), for all indications of reference product 

• As per the 2024 license & supply agreement, Alvotech is responsible for the development & manufacturing of AVT03, while Dr. Reddy’s handles registration & marketing in licensed regions, incl. the U.S. 

• AVT03 is a fully human anti-RANKL mAb that will be available in single-dose pre-filled syringes (60mg/1mL) & single-dose vials (120mg/1.7mL or 70mg/mL) post approval    

7. Xbrane Entered into an Agreement with Alvotech to sell XB003 (Biosimilar, Cimzia) and Parts of its Organization for ~$27.25M 

Company: Xbrane and Alvotech 

Product: XB003 

Active Ingredient: Certolizumab Pegol 

Reference Product: Cimzia 

Reference Product Company: UCB 

Disease: Crohn’s Disease, Polyarticular Juvenile Idiopathic Arthritis, Psoriatic Arthritis, Ankylosing Spondylitis, Non-radiographic Axial Spondyloarthritis, and Mod. To Sev. Plaque Psoriasis & Rheumatoid Arthritis 

Date: Mar 20, 2025   

Shots: 

• Xbrane has signed an agreement with Alvotech to sell XB003 (Biosimilar, Cimzia) including related IP and parts of its organization, including 40 employees & laboratory equipment at ~$27.25M (~SEK 275M). The transaction closing is subject to approval from Xbrane's shareholders at the EGM on Apr 14, 2025, and FDI approval.  

• Xbrane will receive SEK 275M (approx. $27.24M) including SEK 102.25M (approx. $10.13M) cash at closing, SEK 152.75M (approx. $15.13M) assumption of outstanding convertible bonds held by CVI Investments, and SEK 20M (approx. $1.98M) assumption of outstanding debt  

• The reduction in Xbrane's organization will lower annual fixed costs by about SEK 120M 

8. Alvotech, Kashiv Biosciences and Advanz Pharma Report the MHRA’s MAA Acceptance of AVT23 (Biosimilar, Xolair) 

Company: Alvotech, Kashiv Biosciences and Advanz Pharma 

Product: AVT23 

Active Ingredient: Omalizumab 

Reference Product: Xolair 

Reference Product Company: Roche 

Disease: Mod. To Sev. Persistent Asthma, CRSwNP, IgE-mediated food allergy & Chronic Spontaneous Urticaria 

Date: Mar 26, 2025   

Shots: 

• The UK’s MHRA has accepted MAA of AVT23, a proposed biosimilar of Xolair (omalizumab) for the treatment of severe persistent allergic asthma & CRSwNP 

• Alvotech & Advanz Pharma entered into a commercialization agreement for AVT23 in Feb 2023, expanding their alliance in May to incl. 5 more biosimilars, whereas in Oct 2023, Alvotech & Kashiv signed a licensing agreement for AVT23 

• Omalizumab is a humanized mAb that binds to free IgE to produce an anti-inflammatory action in allergic asthma & CRSwNP 

9. The US FDA Approves Fresenius’ Conexxence and Bomyntra (Biosimilars, Prolia & Xgeva) 

Company: Fresenius Kabi 

Product: Conexxence & Bomyntra 

Active Ingredient: Denosumab-bnht & Denosumab-bnht 

Reference Product: Prolia & Xgeva 

Reference Product Company: Amgen 

Disease: Osteoporosis & Prevention of Skeletal Related Events 

Date: Mar 26, 2025   

Shots: 

• The US FDA has approved BLA of Conexxence & Bomyntra, biosimilar versions of Prolia & Xgeva (denosumab) for all indications of the reference products 

• Approval was supported by extensive analytical development & similarity assessment based on 2 trials: one assessing its PK, PD, & immunogenicity in healthy volunteers, & other evaluating its efficacy, PD, safety, plus immunogenicity in postmenopausal osteoporosis 

• Additionally, Fresenius & Amgen have reached a global settlement, allowing the US launch of these biosimilars from mid-2025 & their European launch in late H2’25, pending regulatory approval 

10. Bio-Thera Collaborates with Dr. Reddy’s for the Commercialization of BAT2206 (Biosimilar, Stelara) & BAT2506 (Biosimilar, Simponi) Across the Southeast Asia 

Company: Bio-Thera and Dr. Reddy’s 

Product: BAT2206 & BAT2506 

Active Ingredient: Ustekinumab & Golimumab 

Reference Product: Stelara & Simponi 

Reference Product Company: Johnson & Johnson  

Disease: Rheumatoid Arthritis, Psoriatic Arthritis, Ankylosing Spondylitis, Plaque Psoriasis, Crohn’s Disease, and Ulcerative Colitis   

Date: Mar 26, 2025   

Shots: 

• Bio-Thera and Dr. Reddy’s have entered into an exclusive commercialization and license agreement for BAT2506, a biosimilar version of Simponi (golimumab) & BAT2206, a biosimilar version of Stelara (ustekinumab) 

• As per the agreement, Bio-Thera will handle the development, manufacturing, and supply of BAT2206 & BAT2506, while Dr. Reddy’s will manage regulatory approvals & commercialization in Southeast Asia (Cambodia, Indonesia, Malaysia, Philippines, Thailand, and Vietnam) and hold exclusive commercial rights for BAT2206 in Colombia 

• BAT2506 & BAT2206 is a mAb targeting TNF-alpha & blocks IL-12 and IL-23 by preventing p40 from binding to the IL-12Rβ1 receptor on immune cells, respectively 

11. Celltrion Launches Remdantry (Biosimilar, Remicade) Across Canada 

Company: Celltrion 

Product: Remdantry 

Active Ingredient: Infliximab 

Reference Product: Remicade 

Reference Product Company: Johnson & Johnson 

Disease: Rheumatoid Arthritis, Plaque Psoriasis, Psoriatic Arthritis, Ankylosing Spondylitis, Crohn’s Disease, and Ulcerative Colitis 

Date: Mar 27, 2025   

Shots: 

• Celltrion has launched Remdantry (formerly Inflectra) injection, a biosimilar to Remicade (infliximab), which will be launched on April 1, 2025, in Canada & received Health Canada NOC on March 7, 2025 

• Remdantry, consisting of a chimeric IgG1 mAb that binds to human TNFα, will share the same DIN as Inflectra. It was approved by Health Canada for rheumatoid arthritis, plaque psoriasis, psoriatic arthritis, ankylosing spondylitis in 2014, and for Crohn’s disease, fistulizing Crohn's disease, and ulcerative colitis in 2016 

• Celltrion offers CELLTRION CONNECT, a patient support program providing reimbursement guidance, financial assistance, and infusion and nurse support throughout treatment 

12. Celltrion's Steqeyma (Biosimilar, Stelara) Adds into the Costco Member Prescription Program 

Company: Celltrion 

Product: Steqeyma 

Active Ingredient: Ustekinumab-stba 

Reference Product: Stelara 

Reference Product Company: Johnson & Johnson 

Disease: Psoriatic Arthritis, Plaque Psoriasis, Crohn’s Disease, Ulcerative Colitis, and Pediatric Plaque Psoriasis & Psoriatic Arthritis 

Date: Mar 27, 2025   

Shots: 

• Celltrion announced that Steqeyma (ustekinumab-stba), a biosimilar to Stelara, has been added to the Costco Member Prescription Program. It was launched on Mar 12, 2025. Celltrion's adalimumab-aaty was added to the program in Aug 2024  

• Steqeyma will be available in the US from Costco Specialty Pharmacies on Apr 1, 2025, for self-funded employer plans, uninsured Costco members paying cash, or those denied insurance coverage 

• Steqeyma, a human IL-12 & IL-23 antagonist, is available as SC injection (45mg/0.5mL or 90mg/1mL in a single-dose, prefilled syringes) & IV infusion (130mg/26mL solution in a single-dose vial) for the treatment of PsO & PsA in adult & pediatric patients, as well as for CD and UC adult patients 

13. Shanghai Henlius Biotech and Organon Reports EMA’s Validation of HLX11 (Biosimilar, Perjeta) 

Company: Shanghai Henlius Biotech and Organon 

Product: HLX11 

Active Ingredient: Pertuzumab 

Reference Product: Perjeta 

Reference Product Company: Roche 

Disease: HER2+/HR- Locally Advanced Breast Cancer 

Date: Mar 28, 2025   

Shots: 

• The EMA has validated MAA of HLX11, a biosimilar version of Perjeta (pertuzumab) for all indications of the reference product 

• Submission was supported by P-III trial evaluating HLX11 vs Perjeta as neoadj. therapy in HER2+/HR-, early stage or locally advanced breast cancer as part of complete treatment regimen. Study met its 1EP of total pathological complete response (tpCR) per IRC & demonstrated comparable 2EPs 

• Additionally, Henlius granted Organon exclusive global commercialization rights (excl. China) for 2 biosimilar candidates, incl. HLX11, as per a license & supply agreement signed in 2022 

Related Post: Key Biosimilars Events of February 2024