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 January, Coherus BioSciences divested its Ophthalmology Franchise that included Cimerli and Glenmark launched Lirafit, biosimilar of Liraglutide for Type 2 Diabetes Mellitus in India. Our team at PharmaShots has summarized 09 key events of the biosimilar space of January 2024 

Glenmark Introduces Lirafit (Biosimilar, Liraglutide) for Type 2 Diabetes Mellitus in India 

Date: Jan 03, 2024  

Product: Lirafit (biosimilar, Liraglutide) 

• Following the approval from the Drug Controller General of India (DCGI), Glenmark has introduced the first biosimilar of Liraglutide under the brand name Lirafit (1.2mg, per day) for managing type 2 diabetes mellitus in India 

• Lirafit gained approval based on a 24wks. study in type 2 diabetes mellitus Indian adult patients which showed its effectiveness, safety, and good tolerance. Its efficacy and safety profile were found to be non-inferior to the reference liraglutide 

• The reference drug, Liraglutide, is a GLP‐1 receptor agonist that enhances glucose-dependent insulin secretion and reduces inappropriate glucagon secretion in adult patients. It is approved in both the US and the EU 

Alvotech Reports Topline Results from the Study of AVT06 (Biosimilar, Eylea) for Eye Disorders 

Date: Jan 03, 2024  

Product: AVT06 

• The (AVT06-GL-C01) confirmatory trial investigated the efficacy, safety, and immunogenicity of AVT06 vs Eylea for the treatment of neovascular (wet) AMD  

• The results revealed that the trial met its 1EP of baseline to wk. 8 in Best-Corrected Visual Acuity (BCVA) showing therapeutic similarity between AVT06 and Eylea 

• AVT06, recombinant fusion protein, binds with VEGF to inhibit its activation, neovascularization and vascular permeability  

Accord BioPharma Reports US FDA’s Acceptance of BLA for DMB-3115 (Biosimilar, Stelara)   

Date: Jan 04, 2024 

Product: DMB-3115 

• The US FDA has accepted the BLA for DMB-3115 based on the results from P-III multi-regional studies for treating plaque psoriasis having rate of change in the Psoriasis Area and Severity Index (PASI) for skin symptoms as its 1EP. The results showed similar quality, safety and efficacy between DMB-3115 vs Stelara 

• Accord BioPharma (subsidiary, Intas Pharmaceuticals) holds US commercialization rights to DMB-3115 which was jointly developed by Dong-A Socio Holdings and Meiji Seika Pharma  

• Additionally, the company has submitted 3 separate BLAs to the US FDA for its biosimilar versions of trastuzumab, pegfilgrastim, and filgrastim  

STADA and Alvotech’s Uzpruvo (Biosimilar, Stelara) Obtains EC’s Approval for Immune-Mediated Diseases 

Date: Jan 10, 2024 

Product: Uzpruvo (AVT04) 

• Followed by the CHMP’s positive opinion in Nov 2023 for Crohn’s disease, psoriasis and psoriatic arthritis, the EC has approved Uzpruvo across the EU and Iceland, Liechtenstein, and Norway 

• The approval was based on the analytical & clinical results, data from the study (AVT04-GL-301) comparing the safety and efficacy of AVT04 vs Stelara for treating chronic plaque-type psoriasis demonstrating its similarity as well as results from the (AVT04-GL-101) study showing similar PK characteristics 

• Additionally, Alvotech holds rights to develop and manufacture Uzpruvo while STADA is responsible for the commercialization in the EU as per the agreement signed in 2019 

Coherus BioSciences to Divest its Ophthalmology Franchise to Sandoz for $170M Up Front 

Date: Jan 22, 2024  

Product: CimerliI (ranibizumab-eqrn) 

• Coherus signs an agreement with Sandoz to divest its ophthalmology franchise which includes a lead asset Cimerli (ranibizumab-eqrn) along with its supporting commercial infrastructure 

• As per the terms of the agreement, Coherus will receive an all-cash consideration of $170M as up-front payment along with an additional amount for Cimerli product inventory & subject to customary working capital adjustments at the closing date. The transaction is expected to close by H1’24 

• Moreover, the divestiture also includes Coherus’ BLA for Cimerli, ophthalmology sales, select field reimbursement teams, Cimerli product inventory on hand & the access to proprietary commercial software 

Celltrion Reports BLA Submission for CT-P47 (Biosimilar, Actemra) to the US FDA for Treating Rheumatoid Arthritis   

Date: Jan 28, 2024 

Product: CT-P47 

• Celltrion has submitted BLA to the US FDA seeking approval for CT-P47 in both IV and SC route of administrations based on the P-III study   

• The P-III study assesses the safety, efficacy, PK, and immunogenicity of CT-P47 vs Actemra for treating moderate to severe active rheumatoid arthritis with inadequate response to methotrexate up to wk. 52 

• CT-P47 is a recombinant humanized mAb which targets interleukin 6 (IL-6) receptor indicated for treating rheumatoid arthritis 

Boan Biotech Highlights Clinical Updates for BA6101 (biosimilar, Prolia) and BA1102 (biosimilar, Xgeva) to Treat Various Indications 

Date: Jan 29, 2024  

Product: AVT03 

• The company has completed patient enrolment in P-III trial which evaluates the safety, efficacy, PK & immunogenicity of BA6101 & BA1102 vs reference drugs (Prolia & Xgeva) for the treatment of various indication across Europe, United States & Japan 

• Boan also conducted a meeting in Germany to highlight the PK results from the P-I analysis of BA6101 vs Prolia across Europe. The study met the pre-specified acceptance criteria of bioequivalence for PK & PD along with a similarity in PK, PD, safety & immunogenicity 

• Earlier in Nov 2022, the company launched BA6101 (Boyoubei) across China and received positive feedback from doctors & patients on its clinical application. Later in Mar 2023, the NMPA accepted the BLA for BA1102 

Alvotech Reports Data from the Trial of AVT03 (Biosimilar, Prolia and Xgeva) for Skeletal Diseases 

Date: Jan 29, 2024  

Product: AVT03 (denosumab) 

• The (AVT03-GL-P01) study assessing safety, PK and tolerability of AVT03 (denosumab) vs Prolia in healthy adult individuals met the 1EPs 

• The confirmatory study of AVT03 in patients and a trial to evaluate PK of AVT03 vs Xgeva in healthy adult individuals is ongoing 

• AVT03, a mAb, targets RANK ligand to reduce the numbers and function of osteoclast for stopping bone resorption and cancer-induced bone destruction   

Sandoz Introduces Tyruko (Biosimilar, Tysabri) for Multiple Sclerosis in Germany 

Date: Jan 31, 2024 

Product: Tyruko (natalizumab) 

• Sandoz has introduced Tyruko (natalizumab), biosimilar of Tysabri for the treatment of r/r multiple sclerosis (RRMS), in Germany which will be available from Feb 1  

• Polpharma Biologics is responsible for the development, manufacturing and supply of Tyruko while Sandoz holds its commercialization rights in all markets as per a global commercialization agreement signed between them in 2019 

• Tyruko is an anti-α4 integrin mAb indicated as a single disease-modifying therapy (DMT) for treating adults with highly active RRMS 

Related Post: Insights+ Key Biosimilars Events of December 2023