Insights+ Key Biosimilars Events of January 2020

• Biosimilars are developed to be highly similar versions of approved biologics in terms of safety, purity, and potency
• Biosimilar is expanding its footprints worldwide with multiple collaborations. In Jan 2020, Pfizer launched its two biosimilars [Ruxience (biosimilar, rituximab) & Trazimera (biosimilar, trastuzumab)] at lowest WAC in the US
• Our team at PharmaShots has summarized key events of the biosimilar space of January 2020

1. Bio-Thera Reported Results of BAT1706 (biosimilar, bevacizumab) in P-III Trial for Patients with Non-Squamous Non-Small Cell Lung Cancer (NSCLC)

Date: Jan 04, 2020

Product:  BAT1706 (biosimilar, bevacizumab)

• The P-III study involved assessing of BAT1706 vs EU Avastin (bevacizumab) + CT in patients with non-squamous NSCLC, evaluating its safety, efficacy, PK & immunogenicity
• The trial resulted in meeting its 1EPs and demonstrated the equivalence in ORR for 1L patients with advanced non-squamous NSCLC
• BAT1706 is mAb & second biosimilar in Bio-Thera’s portfolio works as a vascular endothelial growth factor (VEGF) protein. Avastin is a mAb targeted to treat patients with metastatic colorectal cancer, non-squamous NSCLC, recurrent glioblastoma, metastatic RCC, persistent, recurrent, or metastatic CC, and epithelial ovarian, fallopian tube, or primary peritoneal cancer

2. Mundipharma Collaborated with Samsung Bioepis to Commercialize Multiple Biosimilar Candidates in Hong Kong and Taiwan

Date:  Jan 12, 2020

Products: SB5 (adalimumab), SB4 (etanercept), SB3 (trastuzumab), SB8 (bevacizumab)

• Mundipharma got exclusive commercialization rights for Samsung Bioepis first-wave biosimilar candidates in Taiwan and Hong Kong while Samsung Bioepis will remain MAH, responsible for the development, regulatory and manufacturing activities of therapies
• The biosimilar candidates include SB5 (adalimumab), SB4 (etanercept), SB3 (trastuzumab), and SB8 (bevacizumab) targeting immunology & oncology
• The collaboration combines Samsung Bioepis biosimilar development platform with Mundipharma’s commercial acumen and market insight to address the medical needs of patients in the licensed territories

3. Coherus Signed a License Agreement with Innovent Biologics to Commercialize Biosimilar of Avastin (bevacizumab) in the US and Canada

Date:  Jan 13, 2020

Product: Biosimilar of Avastin (bevacizumab)

• Innovent received $45M as upfront, development & regulatory milestone and royalties on sales of the therapy in the licensed territories while Coherus plans to file BLA to the US FDA in H2’20 or H1’21. Additionally, Coherus get an option to commercialize Innovent’s biosimilar to Rituxan (rituximab) in the US and Canada
• If option exercises, financial terms will be the same as a biosimilar to Avastin. The agreement fosters Coherus oncology pipeline and leverages its commercial infrastructure in the US
• Innovent’s biosimilar to Avastin has completed its P-III study in China with its accepted NMPA application in 2019 and has received PR status. Addition of Avastin biosimilar complements Coheres Udenyca and advance its focus to improves patient access and lower healthcare costs in the US

4. JAMP Signed an Agreement with Alvotech to Commercialize Five Biosimilars in Canada

Date:  Jan 15, 2020

Product: Biosimilar

• JAMP got exclusive commercialization right for Alvotech’s five biosimilar therapies, having the market value of ~2B annually in Canada
• The collaboration allows JAMP to expand its generic portfolio, expected to exceed 500 products by 2022 and now has six biosimilars in its pipeline leading to an improvement in patient access to the therapies
• The partnership advances Alvotech’s fully integrated value chain from cell line development to commercial manufacturing and allows patients to utilize biosimilars as well as the JAMP care patient support program in Canada

5. Pfizer Launched Two Oncology Biosimilars at Lowest Wholesale Acquisition Cost in the US

Date: Jan 24, 2020

Products:  Ruxience (biosimilar, rituximab), Trazimera (biosimilar, trastuzumab)

• Pfizer launched two oncology biosimilars, Ruxience (biosimilar, rituximab) & Trazimera (biosimilar, trastuzumab) at lowest WAC among all the biosimilars present in the market
• Pfizer will launch Ruxience today at WAC of $71.68/10mg or 24% discount to the WAC of Rituxan while Trazimera at WAC of $80.74/10 mg or 22% discount to the WAC of Herceptin. Zirabev was launched on Dec 31, 2019 at $61.34/10mg or 23% discount to the WAC of Avastin
• Ruxience referencing Roche’s Rituxan, available for NHL, CLL, GPA and MPA while Trazimera referencing Roche’s Herceptin, indicated for the treatment of HER2+ BC and HER2 overexpressing GE. Zirabev referencing Roche’s Avastin and is available to treat multiple cancer indications

6. Vizient Submitted Response to the US FDA for Draft Guidance on Biosimilars Developments

Date:  Jan 28, 2019

Product: Biosimilar

• The company submitted a report for the FDA’s guidance on Clinical Immunogenicity Considerations for Biosimilar and Interchangeable Insulin Products clarifying the clinical immunogenicity study for the approval of certain proposed biosimilars and interchangeable insulin products
• The guidance suggests recommendations as to when and whether comparative clinical immunogenicity study will be needed for insulins to support the application under the US FDA
• In May 2019, the US FDA conducted a public hearing for biosimilars namely:  The Future of Insulin Biosimilars, Increasing Access and Facilitating the Efficient Development of Biosimilar and Interchangeable Insulin Products, and is also supported by Vizient. The approval of biosimilars and interchangeable insulins will further access in decreasing health care expenses and will give multiple options for patients with diabetes  

7. Amgen Launched Amgevita (biosimilar, adalimumab) for the Treatment of Inflammatory Diseases in Brazil

Date: Jan 30, 2020

Product: Amgevita (biosimilar, adalimumab)

• Amgen reported the launch and commercialization of Amgevita, a biosimilar of adalimumab, available in Brazil
• The ANVISA’s approval is based on the clinical study demonstrating bio-similarity with the reference biological product, via vitro analyzes, PK & clinical information in patients with moderate to severe psoriasis and RA
• Amgevita is a fully human IgG1 mAb targeting TNFa, a cytokine which mediates the inflammatory response and has received ANVISA’s approval for RA, PsO, CD, UC, axSpA, HS in Apr’2019

8. Pfizer’s Ruxience (biosimilar, rituximab) Received CHMP’s Positive Opinion for Cancer and Autoimmune Diseases

Date:  Jan 31, 2020

Product:   Ruxience (biosimilar, rituximab)

• The EMA’s CHMP has adopted a positive opinion, recommending MAA for Ruxience, a biosimilar referencing MabThera
• The regulatory submission is based on REFLECTIONS B3281006 study assessing the efficacy, safety, immunogenicity, PK/PD of Ruxience demonstrating bio-similarity to the reference product in patients with CD20+, low tumor burden FL
• Ruxience is a mAb indicated for the treatment of NHL, CLL, RA, GPA, MPA, PV and has received the US FDA’s approval in 2019 with its anticipated EC’s approval in H1’20. If approved, RUXIENCE will be Pfizer’s fifth oncology biosimilar to receive regulatory approval in EU