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   

• During March, Sandoz received the US FDA’s approval for Wyost & Jubbonti. Our team at PharmaShots has summarized 7 key events of the biosimilar space of March 2024 

Biocon Enters into an Exclusive License Agreement with Bayer and Regeneron for the Commercialization of Yesafili (biosimilar, aflibercept) into the Canadian Market 

Date: Mar 4, 2024 

Product: Yesafili 

Shots: 

• Biocon, Bayer & Regeneron have signed an agreement to commercialize and distribute Yesafili, the biosimilar version of Eylea (aflibercept) Injections across Canada  

• Under the terms of the agreement, Biocon has set Jul 1, 2025, as the launch date for Yesafili (2mg NDS for vials and prefilled syringes). Earlier in Mar 2023, Health Canada approved Yesafili (2mg vials), subject to the resolution of any patent issues 

• Eylea is an injectable drug developed and approved for the treatment of various indications including Neovascular (Wet) Age-Related Macular Degeneration (AMD), Macular Edema Following Retinal Vein Occlusion (RVO), Diabetic Macular Edema (DME), etc.  

Sandoz Reports the US FDA’s Approval of Wyost and Jubbonti (Biosimilar, Denosumab) 

Date: Mar 6, 2024 

Product: Wyost and Jubbonti 

Shots: 

• Sandoz has received the US FDA’s approval for Wyost & Jubbonti (denosumab-bbdz), biosimilars of Xgeva & Prolia (denosumab), based on the clinical studies demonstrating their similarity with the reference drugs 

• The company’s Jubbonti Risk Evaluation & Mitigation Strategy (REMS) program has also been approved to educate HCPs & patients about the severe hypocalcemia risk associated with Jubbonti in advanced CKD, incl. dialysis-dependent patients 

• Wyost is indicated for preventing SREs in MM patients & solid tumor bone metastases, giant cell bone tumor & refractory hypercalcemia while Jubbonti is approved for osteoporosis in postmenopausal women & to increase bone mass associated with certain conditions 

Fresenius Kabi Reports the US FDA’s Approval for Tyenne (Biosimilar, tocilizumab-aazg) as a Treatment of Immunological and Oncological Indications 

Date: Mar 7, 2024 

Product: Tyenne 

Shots: 

• The US FDA approved Fresenius’ Tyenne (tocilizumab-aazg) developed as a biosimilar version of Actemra (tocilizumab)  

• According to the patent settlement agreement signed between Fresenius Kabi and Genentech for Tyenne, Fresenius has the license to market its tocilizumab products across the US as per the undisclosed licensing dates  

• Tyenne functions as an Interleukin-6 (IL-6) receptor antagonist & has been developed using Fresenius’ analytical & manufacturing technologies for treatment of several autoimmune diseases incl. rheumatoid arthritis, giant cell arteritis, polyarticular juvenile idiopathic arthritis & systemic juvenile idiopathic arthritis 

Celltrion Submits BLA to the US FDA for CT-P39 (Biosimilar, Xolair) 

Date: Mar 11, 2024 

Product: CT-P39 

Shots: 

• Celltrion has reported BLA submission for CT-P39, biosimilar version of Xolair (omalizumab), to the US FDA for all indications as of the reference product incl. asthma, chronic rhinosinusitis with nasal polyps (CRSwNP), IgE-mediated food allergy (US only) & CSU 

• The submission was supported by the data, showing comparable efficacy & safety, from P-III study aimed at investigating the safety, efficacy & PK of CT-P39 vs the reference product to treat chronic spontaneous urticaria (CSU) patients for up to wk. 40. The results from wk. 12 were highlighted at the ACAAI conference, 2024 

• Additionally, Xolair’s US formulation patent will expire in Nov 2025 while its compound patent is already expired 

Bio-Thera Solutions and SteinCares Collaborate for Marketing Biosimilars Across LATAM 

Date: Mar 19, 2024 

Product: N/A 

Shots: 

• Bio-Thera Solutions and SteinCares have entered into a new licensing agreement for marketing two biosimilars as per which SteinCares gains exclusive distribution and marketing rights to Bio-Thera's products across Brazil and the rest of the region 

• Under the agreement, Bio-Thera will handle the biosimilars’ development & regulatory submissions with the US FDA & the EMA to support regulatory filings across the LATAM region. It will also handle the commercial supply from its manufacturing facilities in China 

• The collaboration will further utilize SteinCares' reach as well as sales & marketing capabilities for maximum product accessibility in the region 

Dr. Reddy's Laboratories Expects the Launch of Versavo (biosimilar, bevacizumab) for the Treatment of Several Cancer Indications Across the UK  

Date: Mar 19, 2024 

Product: Versavo 

Shots: 

• The company has developed Versavo as a biosimilar of Avastin, approved for the treatment of various cancer indications incl. metastatic colorectal cancer, advanced non-squamous NSCLC, recurrent glioblastoma, mRCC, advanced cervical cancer, ovarian cancer & metastatic breast cancer 

• Based on the clinical evaluation, Versavo is expected to be approved and launched across the UK as a single-use vial in strengths 100 & 400mg  

• Earlier in 2019, Dr. Reddy’s launched Versavo in India and has also launched the Avastin biosimilar in markets across Thailand, Ukraine, Nepal & Jamaica under the same brand name & in Colombia by Persivia 

Celltrion’s CT-P39 (biosimilar, omalizumab) Receives the CHMP’s Recommendation for Marketing Authorization to Treat Multiple Indications 

Date: Mar 25, 2024 

Product: CT-P39 

Shots: 

• EMA received CHMP’s recommendation to grant marketing authorization for full-label application of Celltrion’s CT-P39, developed as a biosimilar to Xolair (omalizumab). The company expects to receive EC’s approval by early May 2024 

• Xolair is a monoclonal antibody approved for the treatment of various indications incl. Allergic Asthma, Nasal Polyps, and Chronic Hives. Recently, Xolair also received approval for the treatment of food allergy indications 

• Moreover, in Mar 2024, the company also completed its application to the US FDA to receive approval for CT-P39. Celltrion aims to expand its biosimilar portfolio to 11 products by 2025 

Related Post: Insights+ Key Biosimilars Events of February 2024