Insights+ Key Biosimilars Events of July 2020

• Biosimilars are developed to be highly similar versions of approved biologics in terms of safety, purity, and potency
• Cadila expanded its footprints in India with the launch of its two biosimilars Bevaro (bevacizumab, biosimilar) and Ritucad (rituximab, biosimilar)
• Our team at PharmaShots has summarized 9 key events of the biosimilar space of July 2020

1. Samsung Bioepis Reported the Initiation of P-III Study for SB15 Proposed Biosimilar to Eylea (aflibercept)

Date: Jul 01, 2020  

Product: SB15 Biosimilar

• The P-III study compared the efficacy, safety, PK, and immunogenicity between SB15 and Eylea in 446 patients with neovascular age-related macular degeneration
• The company has two ophthalmology biosimilar candidates in clinical development, SB11 (ranibizumab) and SB15 (aflibercept). On May 18, 2020, Samsung Bioepis reported 24-week interim results from a P-III study of SB11 (proposed ranibizumab biosimilar)
• SB15 is a proposed biosimilar referencing Regeneron’s Eylea, currently under preclinical treatment for diabetic macular edema, diabetic retinopathy, retinal edema, and retinal vein occlusion

2. Mylan and Fujifilm Kyowa Kirin Received the US FDA’s Approval for its Hulio (biosimilar, adalimumab)

Date: Jul 09, 2020

Product: Hulio (adalimumab-fkjp)

• The US FDA has approved Hulio (adalimumab-fkjp), a biosimilar to AbbVie’s Humira (adalimumab) to treat RA, JIA (in patients aged ≥4yrs.), PsA, AS, adult CD,  UC, and PsO, in both prefilled syringe and auto-injector presentations
• The approval was based on an analytical, pre/ clinical program. The P-III ARABESC study conducted by Fujifilm Kyowa Kirin, demonstrated no differences in terms of safety, efficacy, and immunogenicity compared to its reference product in patients with RA
• In 2018, the companies collaborated to commercialize Hulio in the EU while expanded the agreement globally in 2019. As per the patent license agreement with AbbVie, Mylan will be able to launch Hulio in the US in Jul’2023

3. Bio-Thera Signed a License Agreement with Pharmapark for BAT2506 (golimumab, biosimilar)

Date: Jul 17, 2020  

Product: BAT2506 (golimumab, biosimilar)

• Bio-Thera will take care of full development, and commercial supply of BAT2506 out of the manufacturing facilities in Guangzhou, China. Additionally, the agreement will utilize Pharmapark’s local presence, sales, and marketing capabilities in Russia and other CIS countries
• Pharmapark to get exclusive rights to distribute and market the product in Russia and other CIS countries including its filing practices. In Q4’20, Bio-Thera to begin its global P-III trial in PsA patients and will include patients from China, Russia, and many other countries 
• Bio-Thera’s BAT2506 is a mAb while the company plans for regulatory submission with NMPA, EMA and the US FDA in 2023

4. Cadila to Launch its Bevaro (bevacizumab, biosimilar) in India

Date: Jul 22, 2020  

Product: Bevaro (bevacizumab, biosimilar)

• Cadila plans to launch multiple biosimilars including Bevaro in 2020 which are safe and efficacious compared to conventional treatment therapies
• The company has also cleared he USFDA inspection in Feb’20 and holds approved 16 ANDAs plus currently filed 30 ANDAs  
• Bevaro is a mAb will be available in two strengths of 100 and 400 mg targeted for Ovarian Cancer, Glioblastoma Multiforme (a type of Brain cancer), Colorectal Cancer, Breast Cancer, Lung Cancer, Cervical Cancer and Kidney Cancer in India

5. Centus Biotherapeutics’ Equidacent (bevacizumab, biosimilar) Received CHMP’s Positive Opinion for the Treatment of Multiple Cancer Indications

Date: Jul 27, 2020

Product: Equidacent (bevacizumab, biosimilar)

• The EMA’s CHMP has adopted a positive opinion that recommended the MAA of Centus’ Equidacent (bevacizumab), a biosimilar to Roche’s Avastin to treat carcinoma of the colon or rectum, breast cancer, NSCLC, RCC, epithelial ovarian, fallopian tube or primary peritoneal cancer, and carcinoma of the cervix
• Equidacent will be available as 25 mg/ml as the solution for infusion targeting VEGF and act by inhibiting the binding of VEGF to its receptors on endothelial cell
• The company anticipates EC’s decision in ~60days. The clinical data demonstrated that Equidacent has comparable quality, safety, and efficacy to Avastin

6. NCCN Collaborated with Pfizer to Explore Adoption of Biosimilars in Oncology

Date: Jul 27, 2020

Products: Biosimilars

• NCCN and Pfizer issued an open RFP that can develop and validate enduring approaches to improve the safe, effective, and efficient adoption of biosimilars in oncology
• The RFP supports approaches to improve the processes related to biosimilar adoption in oncology. Letters of Intent are welcome from academic or community centres, patient advocacy groups, and HCPs organizations in the US and are due on Sept 09, 2020
• The NCCN ORP will boost up the discovery that improves the lives of people with cancer and supports preclinical, translational, clinical research and quality improvement projects in oncology

7. Celltrion’s Remsima SC (infliximab, CT-P13) Received the EC’s MAA for Additional Five Indications

Date: Jul 27, 2020  

Product: Remsima SC (infliximab, CT-P13)

• The approval followed the EMA’s CHMP positive opinion based on a study assessing Remsima SC (120 mg) vs IV formulations in patients with Crohn’s disease and ulcerative colitis, evaluating its PK, efficacy, and safety
• The study resulted in high efficacy and safety comparable with IV formulation and the SC administration will also reduce the treatment time to approximately 2-5 minutes
• Remsima is a world’s first mAb indicated to treat eight autoimmune diseases including RA & IBD and approved in the US & EU with Inflectra & Remsima respectively. Till now the product is approved in 94 countries including the US, Canada, Japan and throughout EU

8. Cadila to Launch its Ritucad (rituximab, biosimilar) in India

Date: Jul 27, 2020  

Product: Ritucad (rituximab, biosimilar)

• Cadila to strengthen its biosimilar portfolio and oncology footprints in India with the launch of Ritucad and has cleared USFDA inspection in Feb’20
• Additionally, the company has launched its Bevaro (bevasizumab, biosimilar) a mAb targeted for multiple cancer indications like Ovarian Cancer, Glioblastoma Multiforme, Colorectal Cancer, Breast Cancer, Lung Cancer, Cervical Cancer and Kidney Cancer in India
• Ritucad is the second biosimilar in Cadila’s portfolio of biosimilars and will be available in a single-dose vial of two strengths, 100 mg & 500mg targeted to treat Non-Hodgkin’s lymphoma and RA

9. Henlius and Accord’s Zercepac (trastuzumab, biosimilar) Received the EMA Approval for HER2-Positive Breast Cancer and Gastric Cancer

Date: Jul 30, 2020

Product: Zercepac (trastuzumab, biosimilar)

• The approval was based on comparative quality studies, clinical studies including preclinical data and resulted in bio-similarity, comparable efficacy, and safety of Zercepac (HLX02) vs Herceptin
• Zercepac is developed under NMPA and EMA biosimilar guidelines and has been evaluated with the reference trastuzumab including comparative quality studies, preclinical studies, a P-I clinical study and a global multi-centre P-III clinical study
• Zercepac is a novel China-mAb approved in the EU for the treatment of HER2+ early breast cancer, HER2+ metastatic breast cancer, and HER2+ metastatic gastric cancer with an expected launch in China in 2020 while its manufacturing site has received EU GMP certificates

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