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 April, Samsung Bioepis and Sandoz received the EC’s Marketing Authorization approval for Pyzchiva. Our team at PharmaShots has summarized 8 key events of the biosimilar space of April 2024 

1. Teva Pharmaceuticals and mAbxience Join Hands to Develop Biosimilar Candidates for Treating Oncology Indications 

Date: Apr 04, 2024  

Product: Undisclosed 

Shots: 

• Teva Pharmaceuticals and mAbxience have signed a strategic licensing agreement across various markets incl. the EU and the US to develop a biosimilar product that is under development as a treatment for various oncology indications 

• As per the agreement, mAbxience will develop and produce the candidates by utilizing the knowledge of biosimilar development & its state-of-the-art along with current Good Manufacturing Practice (cGMP)-approved facilities in Spain & Argentina 

• Furthermore, Teva will be responsible for all the regulatory and commercialization activities across the designated areas for easy access to the patients 

2. Mabwell’s Maiweijian (Biosimilar, Denosumab; 120mg) Receives the NMPA approval for Marketing Authorization in China 

Date: Apr 08, 2024  

Product: Maiweijian 

Shots: 

• The NMPA approved Mabwell’s Maiweijian (Biosimilar, Denosumab; 120mg), an anti-RANKL mAb, to treat unresectable giant cell tumors of the bone or resectable’s which may lead to severe functional impairment 

• Maiweijian vs XGEVA (original product) has shown similarity in PK, PD, clinical efficacy and safety in patients with solid tumor bone metastases 

• The P-I & P-III clinical studies results of the denosumab biosimilar were published in the "International Immunopharmacology" in 2022 and the international journal "JAMA Oncology" in 2024, respectively. Additionally, Mabwell is advancing marketing efforts of MAIWEIJIAN for other indications 

3.Fresenius Kabi Launches Tyenne (Biosimilar, Actemra; IV) to Treat Chronic Autoimmune diseases 

Date: Apr 15, 2024  

Product: Tyenne 

Shots:   

• The company has launched Tyenne (biosimilar, Actemra) in the US, to treat chronic autoimmune diseases; got approved on Mar 05, 2024 

• Tyenne, an Interleukin-6 (IL-6) receptor antagonist developed by using Fresenius’ analytical & manufacturing technologies to treat several autoimmune diseases incl. rheumatoid arthritis, giant cell arteritis, polyarticular juvenile idiopathic arthritis & systemic juvenile idiopathic arthritis 

• In addition to its available biosimilars, Idacio (adalimumab) & Stimufend (pegfilgrastim), company is growing its biosimilars pipeline with late-stage developments for oncology and autoimmune diseases 

4. Teva and Alvotech’s Selarsdi (Biosimilar, Stelara) Receives the US FDA’s Approval 

Date: Apr 16, 2024  

Product: Selarsdi 

Shots: 

• The US FDA has approved Selarsdi (ustekinumab-aekn) injection (SC) for adults & pediatric patients (≥6yrs.) with moderate to severe plaque Pso & active PsA. Teva will commercialize it in the US as per an agreement b/w Teva & Alvotech 

• The approval was based on 2 studies incl. AVT04-GL-301 trial assessing the efficacy, safety & immunogenicity of Selarsdi vs Stelara in moderate to severe chronic plaque Pso patients (n=581) & P-I (AVT04-GL-101) trial assessing the PK, safety, tolerability & immunogenicity of Selarsdi (45mg/0.5mL, SC) vs Stelara in healthy adults (n=294) 

• Both companies have entered into a settlement & license agreement with J&J (Stelara’s manufacturer) to market Selarsdi across the US in Feb 2025 

5. Alvotech and Teva Pharmaceuticals Collaborate to Expand Access for Adalimumab-ryvk (Interchangeable Biosimilar, Humaira) in US 

Date: Apr 19, 2024  

Product: Simlandi 

Shots: 

• Alvotech entered into a long-term agreement with Teva Pharmaceuticals to expand access to newly US FDA-approved higher concentration Adalimumab-ryvk, an interchangeable biosimilar to Humaira in US market 

• The partnership agreement aims to broaden access and further availability assurance of biologics for patients at affordable prices in the US and globally 

• Following commercialization collaboration between companies, SIMLANDI (Adalimumab-ryvk) will be commercialized by Teva in the US 

6. Samsung Bioepis Receives EC’s Marketing Authorization for Pyzchiva (Biosimilar, Stelara) to treat Autoimmune disorders 

Date: Apr 22, 2024  

Product: Pyzchiva 

Shots: 

• The EC has granted marketing authorization for Pyzchiva (Biosimilar, Stelara) to treat autoimmune disorders in gastroenterology, dermatology, and rheumatology 

• The approval was based on P-I & P-III studies of Pyzchiva vs Stelara. P-I trial assessing the PK, safety, tolerability & immunogenicity in healthy volunteers, and  P-III trial assessing the efficacy, safety & PK profile up to 28wks., in moderate to severe plaque PsO patients  

• In Sep’23, Sandoz and Samsung Bioepis signed development and commercialization agreement for the US, Canada, UK, EEA, and Switzerland, following which Sandoz will be responsible for PYZCHIVA’s commercialization 

7. Biogen Receives EMA’s CHMP Positive Opinion for Tofidence (Biosimilar, Roactemra) 

Date: Apr 25, 2024  

Product: Tofidence 

Shots: 

• The EMA’s CHMP has issued a positive opinion recommending approval of Tofidence (Biosimilar, Roactemra; IV) to treat moderate to severely active RA, PJIA, SJIA, and COVID-19 

• The opinion was based on evidence from extensive analytical characterization and PK, safety & immunogenicity of TOFIDENCE including the P-I study examined healthy volunteers compared to the EU and US reference tocilizumab, & P-III study of TOFIDENCE vs. tocilizumab in methotrexate-insufficiently managed RA patients 

• In Apr’21, Biogen and Bio-Thera signed a license agreement for TOFIDENCE. Under which, Biogen holds exclusive rights to regulate, manufacture, and commercialize TOFIDENCE in all countries excluding China, Hong Kong, Macau, and Taiwan 

8. Accord BioPharma’s Hercessi (Biosimilar, Herceptin) Receives the US FDA Approval 

Date: Apr 29, 2024  

Product: Hercessi 

Shots: 

• Accord BioPharma's Hercessi (trastuzumab-strf; 150mg; IV), a biosimilar to Herceptin (trastuzumab), has been approved by the US FDA to treat HER2 overexpressing breast and G/GEJ cancer in the US 

• The approval was based on 2 studies incl. P-I (HLX02-HV01 & HLX02-HV02) trial assessing the single-dose, PK equivalence in healthy volunteers. P-III (HLX02-BC01) trial assessing the safety & efficacy in patients with HER2-overexpressing metastatic breast cancer in combination with docetaxel  

• Company is also developing HERCESSI in 420mg, FDA decision is expected in Q4'24. In 2021, Shanghai Henlius (originator of Hercessi) granted exclusive development and commercial rights of HERCESSI to Accord in US and Canada 

Related Post: Insights+ Key Biosimilars Events of March 2024