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 the patients. Hence, the providers are more likely to adopt biosimilars as a 'reference product to biologics' possessing similar therapeutic properties. During the month of November, Formycon and Bioeq reported the first patient dosing in the P-III study of FYB202 while Prestige collaborated with Teva to commercialize Tuznue. Our team at PharmaShots has summarized 21 key events of the biosimilar space of Nov 2020.

1.Celltrion Presented Results of CT-P17 (biosimilar, adalimumab) in P-III Study for RA at ACR 2020

Published: Nov 03, 2020

Product: CT-P17 (biosimilar, adalimumab)

• The P-III study involves assessing CT-P17 (40mg, q2w) vs reference adalimumab for up to 24wks. in 648 patients with active moderate-to-severe RA despite MTX treatment
• Results demonstrated that CT-P17 has equivalent efficacy to reference adalimumab i.e. ACR20 is 82.7% for both, 2EPs include ACR20/50/70 response rates, mean DAS28, CDAI & SDAI & EULAR (CRP) response, Ctrough of adalimumab is higher for CT-P17 & lower in the ADA positive subgroup than the ADA negative subgroup in both treatment groups, the safety profile is comparable
• Additionally, comparable PK and safety data is presented for CT-P17 in comparison with EU-approved & US-licensed adalimumab in 312 healthy subjects. Celltrion also presented PK and safety data for two delivery methods for CT-P17, the auto-injector (AI) and pre-filled syringe (PFS)

2. Formycon Reported BLA Resubmission Strategy for FYB201 (biosimilar, ranibizumab)

Published: Nov 06, 2020

Product: FYB201 (biosimilar, ranibizumab)

• Formycon & Bioeq reported the BLA resubmission strategy for FYB201 (biosimilar referencing Lucentis) has been adjusted
• With the revised submission strategy, the companies expect a simplification of the approval procedure. The modified submission dossier is anticipated to be filed with the US FDA in H1'21
• The adjustment of the regulatory strategy while optimizing the commercial supply chain is not expected to have any impact on the timing of the anticipated launch of FYB201 in the US & EU

3. Formycon and Bioeq Reported First Patient Dosing in P-III Study of FYB202 (biosimilar, ustekinumab)

Published: Nov 09, 2020

Product: FYB202 (biosimilar, ustekinumab)

• The focus of the P-III study is to demonstrate the comparability of FYB202 & the reference product Stelara in terms of efficacy, safety & immunogenicity in patients with moderate to severe psoriasis vulgaris
• FYB202 is being developed as part of JV b/w Aristo Pharma & Formycon along with Bioeq. Bioeq is responsible for the clinical studies which were developed in close cooperation with the US FDA & the EMA
• The ustekinumab is mAb targeting the cytokines IL-12 & IL-23. Stelara is used to treat various severe inflammatory conditions such as mod. to sev. psoriasis, CD & for UC

4. Alvotech and Cipla Collaborated to Ensure Access to Biosimilars in South Africa

Published: Nov 09, 2020

Product: Biosimilar

• Alvotech and Cipla entered an exclusive partnership to provide patients with better access to high quality and cost-effective biosimilar medicines in South Africa
• Alvotech will be responsible for the development and supply of the products and Cipla will be responsible for the registration and commercialization
• The biosimilar portfolio will include five biosimilars- two for oncology and three for treating auto-immune diseases

5. Genentech Filed Complaint Against Centus Over Proposed Bevacizumab Biosimilar

Published: Nov 13, 2020

Product: Proposed Bevacizumab Biosimilar

• Genentech filed a complaint in the Eastern District of Texas alleging that the proposed biosimilar to Avastin (bevacizumab) product infringes 10 US patents
• Genentech alleges that Centus and partners failed to disclose sufficient information about the proposed biosimilar to enable Genentech to do a sufficient analysis of potential patent infringements
• Centus has a BLA under review with the FDA for the bevacizumab biosimilar candidate FKB238, and the company has filed a notice of intent to commercialize the agent

6. Prestige Signed an Exclusive Agreement with Teva to Commercialize Tuznue (biosimilar, trastuzumab) in Israel

Published: Nov 11, 2020

Product: Tuznue (biosimilar, trastuzumab)

• Teva to get an exclusive right to commercialize Tuznu in Israel, leveraging its marketing capabilities and experience in bringing pharmaceutical products to market and will be responsible for local registration, sales, and marketing in Israel
• Prestige will assume responsibility for product registration with the EMA and commercial supply of Tuznue from its manufacturing facilities in Osong, Korea
• Tuznue is biosimilar referencing Roche's Herceptin (trastuzumab), used to treat HER2-overexpressing BC & m-gastric adenocarcinoma. Additionally, the EMA has accepted an MAA for Tuznue based on the global clinical trial results

7. Samsung Bioepis Initiated P-I Study of SB16 Proposed Biosimilar to Prolia (denosumab)

Published: Nov 11, 2020

Product: SB16 proposed biosimilar to Prolia

• The P-I study assesses the PK/PD, safety, tolerability of SB16 (denosumab) vs Prolia in 168 healthy male volunteers for osteoporosis. The study will be 3 arms study that involves dosing with SB16 either the EU or US-sourced Prolia
• The proposed biosimilar references Amgen's Prolia which was approved in 2010 for osteoporosis with a high risk of fracture
• With the initiation, Samsung Bioepis continues to advance its biosimilar portfolio covering immunology, oncology, ophthalmology, and hematology

8. Henlius Reported First Patients Dosing in P-I Study of HLX14 (denosumab, biosimilar)

Published: Nov 11, 2020

Product: HLX14 (denosumab, biosimilar)

• The first patient has been dosed in a P-I study of HLX14, conducted in 2 parts, Part 1 is a pilot study assessing PK/PD, safety, tolerability & immunogenicity of HLX14 vs EU-sourced denosumab (SC) in healthy male volunteers
• Part 2 is a four-arm study assessing the bioequivalence of HLX14 vs US-, EU-, CN-sourced denosumab. The study also evaluates PD, safety, tolerability, and immunogenicity between HLX14 and the reference drug
• Results from the P-I study will provide reference for the dosing scheme in the clinical studies of HLX14

9. Xbrane Reported Patient Enrollment Completion in P-lll XPLORE Study of Xlucane (biosimilar, ranibizumab)

Published: Nov 11, 2020

Product: Xlucane (biosimilar, ranibizumab)

• Xbrane reported that the last patient has been enrolled into the P-III XPLORE study assessing Xlucane vs Lucentis in 580 patients with wet AMD
• The company will conduct an interim read-out from the XPLORE study when the last patient has reached 6mos. of their treatment schedule. Top-line data is expected to be communicated mid-2021 and filing of the MAA/BLA to EMA and the US FDA anticipated to take place imminently
• Filing of MAA/BLA is expected to take place mid-2021. With an expected 12mos. regulatory process upon filing, MAA is expected in the EU and the US mid-2022 allowing for the launch of Xlucane

10. Henlius Reported the NMPA's Acceptance of HLX15 (biosimilar, daratumumab) to Treat Multiple Myeloma

Published: Nov 16, 2020

Product: HLX15 (biosimilar, daratumumab)

• The NMPA has accepted HLX15's IND to be used in the treatment of multiple myeloma. HLX15 is Henlius second self-developed product around blood tumor treatment
• The company evaluated the biosimilar in a head to head clinical studies demonstrating that HLX15 is highly similar to its reference daratumumab while the safety profiles are also similar
• The company has developed the HLX15 in accordance with the technical guidelines of development and evaluation of biosimilar drugs and EMA guideline on similar biological medicinal products

11. Samsung Bioepis Presented Results of SB11 Proposed Biosimilar to Lucentis in P-III Study at the AAO 2020 Virtual

Published: Nov 16, 2020

Product: SB11 proposed biosimilar to Lucentis

• The P-III study involves assessing SB11 vs reference ranibizumab in monthly injections (0.5 mg) in 705 patients in a ratio (1:1) with nAMD while only 634 patients continued to receive treatment up to 48wks.
• One-year results from the P-III study demonstrated equivalence between SB11 and reference ranibizumab in patients with nAMD
• The study met its 1EPs i.e. changes from baseline in BCVA @8wks. and CST @4wks. The EMA has accepted for review the MAA of SB11 in Oct'2020

12. Samsung Bioepis and Biogen Reported the FDA's Acceptance of BLA for SB11 Proposed Biosimilar to Lucentis

Published: Nov 18, 2020

Product: SB11 proposed biosimilar to Lucentis

• The US FDA has accepted for review the BLA of SB11, a proposed biosimilar referencing Lucentis (ranibizumab)
• The EMA has accepted for review the MAA of SB11 in Oct'2020. If approved, SB11 will add to the biosimilars portfolio developed under the collaboration of Samsung Bioepis and Biogen including Benepali, Imraldi & Flixabi
• In Nov'2019, Samsung Bioepis entered into a commercialization agreement with Biogen for 2 ophthalmology biosimilar candidates, SB11 (ranibizumab) & SB15 (aflibercept) in the US, Canada, Europe, Japan & Australia. Ranibizumab is an anti-VEGF therapy for retinal vascular disorders

13. The US FDA Draft New Guidelines for Biosimilarity and Interchangeability

Published: Nov 19, 2020

Product: Biosimilar

Shots:

• The FDA has released a draft guidance for industry entitled  Biosimilarity and Interchangeability: Additional Draft Q&As on Biosimilar Development and the BPCI Act 
• The draft guidance is intended to inform prospective applicants and facilitate the development of proposed biosimilars and proposed interchangeable products, as well as describe FDA's interpretation of statutory requirements added by the BPCI Act
• The draft guidance is to be published in the Federal Register on Nov 20, 2020

14. Alvotech Reported the US FDA and EMA's Acceptance of AVT02 Proposed Biosimilar to Humira (adalimumab)

Product: Nov 20, 2020

Product: AVT02, a proposed biosimilar to Humira

• The US FDA has accepted the BLA of AVT02 for review and is expected to decide on the filing in Sept'2021 while the EMA has accepted for review an MAA for AVT02 with an EMA decision anticipated in the Q4'21
• The filings were based on AVT02-GL-101 & AVT02-GL-301 studies demonstrating a high degree of similarity b/w AVT02 and the reference products. AVT02-GL-101 study met its 1EPs of PK similarity while the later study confirmed the efficacy and safety of AVT02 in patients with mod. to sev. chronic psoriasis
• AVT02 is a proposed biosimilar to the reference product Humira (adalimumab) with high concentration (100mg/mL) dosage forms

15. Henlius Presented Results of HLX04 (biosimilar, bevacizumab) in P-III Study at ESMO Asia 2020

Published: Nov 20, 2020

Product: HLX04 (biosimilar, bevacizumab)

• The P-III HLX04-mCRC03 study involves assessing the efficacy, safety and immunogenicity of HLX04 vs reference bevacizumab (7.5 mg/kg, q3w or 5 mg/kg, q2w) + CT (Xelox or mFOLFOX6) as a 1L treatment in patients in the ratio of (1:1) with mCRC
• Result: PFSR36wk (46.4% vs 50.7%); no significant difference b/w the treatment groups in 2EPs including OS, PFS, ORR, TTR and DoR; safety and immunogenicity profiles were similar b/w HLX04 and the reference
• The NMPA has accepted the NDA for HLX04. Additionally, Henlius has submitted a patent for a new formulation of HLX04 with potential better safety and stability, designed for ophthalmic use

16. Samsung Biologics and AstraZeneca Dissolved Rituximab Alliance

Published: Nov 20, 2020

Product: SAIT101 (biosimilar, rituximab)

• Samsung Biologics and AstraZeneca had decided to suspend long-running research and development activities by a jointly owned subsidiary, Archigen Biotech, which was solely engaged in development of SAIT101 (biosimilar, rituximab)
• Samsung halted the P-III study of SAIT101 in Oct’2012 and resumed it in 2014 via Archigen. The P-III study similar therapeutic effect to Rituxan in 315 FL patients with ORR (66.3% vs 70.6%)
• The companies decided to stop commercializing SAIT101 and take step for liquidation of Archigen as the product lacks commercial viability

17. The US FDA Approved Pfizer's Oncology Supportive Care Biosimilar Nyvepria (biosimilar, pegfilgrastim)

Product: Nov 20, 2020

Product: Nyvepria (biosimilar, pegfilgrastim)

• The EC has approved Nyvepria, a biosimilar referencing Neulasta to reduce the duration of neutropenia and the incidence of febrile neutropenia in adult patients treated with cytotoxic CT for malignancy
• The EC approval is based data demonstrating a high degree of similarity of Nyvepria to its reference product
• Pfizer plans to make Nyvepria available to patients in multiple EU countries starting in Q1'21. The EC’s approval follows the US FDA's approval granted in Jun'2020

18. Innovent Reported Results of Tyvyt + Byvasda (biosimilar, bevacizumab) in P-lll ORIENT-32 Study as 1L Treatment for HCC

Product: Nov 23, 2020

Product: Byvasda (biosimilar, bevacizumab)

• The P-lll ORIENT-32 study involves assessing of Tyvyt (sintilimab) + Byvasda vs sorafenib as a 1L treatment in 571 patients in a ratio (2:1) with advanced HCC and the result were released in an oral presentation at the ESMO Asia Virtual Congress 2020
• Result: Reduction in risk of all-cause mortality (43.1%); the median OS (not reached vs 10.4 mos.); reduction in risk of progression (43.5%); m-PFS (4.6 vs 2.8 mos.), results was presented at ESMO 2020
• The improved OS and PFS benefits of the dual regimen were generally consistent across all subgroups and showed an acceptable safety profile with no new safety signals

19. Innovent's Sulinno (biosimilar, adalimumab) Received NMPA's Approval for Polyarticular Juvenile Idiopathic Arthritis

Published: Nov 23, 2020

Product: Sulinno (biosimilar, adalimumab)

• The NMPA has approved Sulinno for the treatment of pJIA which is the fourth approved indication of the therapy in China. Earlier, Sulinno was approved for RA, PS, and psoriasis
• The launch of Sulinno has provided more Chinese patients with high-quality and relatively affordable adalimumab injection, bringing hope and opportunities to more patients
• Sulinno is a human anti-TNF-a mAb referencing Humira. The clinical results were published at the Inaugural Issue of The Lancet Rheumatology in 2019

20. Alvotech and Alvotech & CCHT Signed an Exclusive Commercialization Agreement with Yangtze River for Eight Biosimilars in China

Product: Nov 25, 2020

Product: Biosimilar

• The companies collaborate with the Yangtze to commercialize eight biosimilars in China. The initial pipeline contains biosimilar candidates for the treatment of autoimmunity, ophthalmology, and oncology
• Alvotech and Alvotech & CCHT will be jointly responsible for the development, registration, and supply of biosimilars in China while Yangtze River Pharmaceutical will exclusively commercialize the biosimilars
• The manufacturing of biosimilars will be made in a new state-of-the-art biopharmaceutical facility, currently being built in Changchun, China, through the Alvotech & CCHT. The first phase of the facility is expected to be completed in 2021

21. Bio-Thera Reported MAA Submission to EMA for BAT1706 a Proposed Biosimilar to Avastin

Product: Nov 26, 2020

Product: BAT1706 (a proposed biosimilar to Avastin)

• The company has submitted an MAAA for BAT1706 to EMA. Bio-Thera seeks a commercial license for all approved indications of bevacizumab in the EU Member States, Iceland, Norway, and Liechtenstein
• The submission of the MAA for BAT1706 marks it as the first ex-China MAA/ BLA submission. The BLA of the biosimilar for metastatic carcinoma of the colon or rectum and NSCLC is under NMPA’s review
• The company plans to submit a BLA for BAT1706 to the US FDA by the end of 2020. Bevacizumab is a mAb that targets VEGF thus reduces neovascularization, thereby inhibiting tumor growth

Related Post: Insights+ Key Biosimilars Events of October 2020