Insights+ Key Biosimilars Events of May 2020
- Biosimilars are developed to be highly similar versions of approved biologics in terms of safety, purity, and potency
- Fresenius Kabi expanded its footprints with the acceptance of MAA and BLA of its MSB11455 (biosimilar, pegfilgrastim) in the EU and the US respectively, and also signed an agreement with Medec to commercialize Idacio (adalimumab, biosimilar) in Germany
- Our team at PharmaShots has summarized 14 key events of the biosimilar space of May 2020
1. Revance and Mylan to Extend Biosimilar to Botox Program Decision Beyond April 30, 2020
Date: May 04, 2020
Product: Botox
- Revance is in discussion with Mylan regarding whether Mylan plans to move forward or not with the biosimilar to the Botox program. The expected decision date for Mylan is Apr 30, 2020, or thirty days from the date that Revance provides Mylan with certain deliverables regarding the program
- In Sep 2019, the companies amended their agreement to include an additional $5M to Revance in exchange for an extended decision period for Mylan to move forward with a development program. Revance has carried out additional characterization work and analysis for the benefit of the program
- In Feb 2018, the companies collaborated for development and regulatory approval of Botox's biosimilar. Revance received $25M as upfront and granted commercialization rights to Mylan in the US, the EU, and ROW
Date: May 08, 2020
Product: Remsima SC (biosimilar, infliximab)
- The company has launched the Remsima SC, a biosimilar referencing Janssen's Remicade (infliximab) on Apr 27, 2020. The clinical study demonstrated Remsima SC has similar results in efficacy and safety compared to the IV formulation
- The launch followed market releases of the product in Germany and the UK in Feb and Mar'20 respectively. Before the launch in the Netherlands, the company had an online symposium, attended by 200 medical professionals on Apr 21, 2020
- Celltrion collaborated with CZ to reimburse the entire treatment fee for Remsima SC and allows patients to administer it directly at home. Additionally, CZ's SC formulation is more expensive than IV formulation, but 'Remsima SC' is expected to be a good alternative to the infliximab formulation
3. Alvotech Reports Results of AVT02 (a proposed biosimilar to adalimumab) in Two Clinical Studies for Autoimmune Diseases
Date: May 13, 2020
Product: AVT02 (bisomilar, adalimumab)
- The P-I AVT02-GL-101 study compares the PK, safety, and tolerability of AVT02 to EU & US Humira and the PK of EU and US-Humira following a 40mg (SC) inj. in 392 healthy volunteers. The study has met its 1EP i.e. all PK endpoints are within the equivalence margins for all pairwise comparisons and demonstrated PK similarity of AVT02 to the Humira
- The P-III AVT02-GL-301 study assesses AVT02 vs Humira in 412 patients with mod.-to-sev. chronic plaque psoriasis. The study met its 1EPs by demonstrating equivalent efficacy as measured by the PASI improvement @16wks.
- AVT02 is mAb, a proposed biosimilar to Humira (adalimumab) with high concentration (100mg/mL) dosage forms
4. Formycon To Update on its Biosimilar Programs
Date: May 15, 2020
Products : FYB201 (biosimilar, ranibizumab), FYB202 (biosimilar, ustekinumab), FYB203 (biosimilar, aflibercept)
- Formycon signs an agreement with Bioeq AG and manufacturing partner for resubmission of BLA for the FYB201 project (biosimilar, ranibizumab). Bioeq AG is in talks with the US FDA for resubmission supporting manufacturing data in the H2'20
- In Oct 2019, Formycon's FYB202 (biosimilar, ustekinumab) has completed its P-I trial with its initiation of the P-III trial in Q3'20. FYB202 is a co-developed product with Aristo Pharma and Formycon AG while Aristo holds 75.1% and Formycon AG 24.9% and Bioeq will sponsor the trial
- FYB203 (biosimilar, aflibercept) has received approval for neovascular age-related macular degeneration and is expected for P-III trial in mid-20 while Klinge Biopharma GmbH acquires the marketing rights for FYB203 from Santo Holding. Formycon's FYB206 is in the preclinical phase and its IP is established with a filling of patent application
Date: May 18, 2020
Product: JHL1266 (biosimilar, denosumab)
- The study involves assessing JHL1266 vs Prolia sourced from the EU and the US in healthy human subjects evaluating its PK, PD, and immunogenicity
- The JHL1266 is proved to be a milestone and an initiative in bringing safe, effective, and high-quality biologics
- JHL1266 is a mAb targeting RANKL works by inhibition of developed osteoclasts and then preventing break down of bones in the human body and is targeted for osteoporosis, bone metastases, giant cell tumors of bone, and other treatment-induced bone loss
Date: May 19, 2020
Product: SB11 ( biosimilar ranibizumab)
- The P-III study involves assessing of SB11 vs reference product, Lucentis in monthly injections (0.5mg) in 705 patients in a ratio (1:1) with AMD
- The P-III study results demonstrated equivalent efficacy in terms of change in BCVA @8wk. and CST @4wk., LS change in BCVA (6.2 vs 7.0 letters), LS change in CST ( -108.4µm vs -100.1µm), AEs (66.0% vs 66.9%). The data was to be presented at ARVO 2020 which has been canceled due to COVID-19
- Additionally, in Nov'2019, Samsung collaborated with Biogen for two ophthalmology biosimilar candidates, SB11 (ranibizumab) and SB15 (aflibercept), in the US, Canada, EU, Japan, and Australia
Date: May 20, 2020
Product: Biosimilars
- Biocon has received the EMA's Certificate of GMP compliance for multiple biologics drug substance (DS) and drug product (DP) manufacturing facilities at Biocon Park, Bengaluru. The facilities are used for the manufacture biosimilars: bevacizumab, trastuzumab, pegfilgrastim and secondary packaging of Insulin Glargine for EU and were inspected in Mar 2020
- The approval expands Biocon's capabilities and allows its trastuzumab and pegfilgrastim to enter in the EU. The company expects that the certification enables the approval of biosimilar bevacizumab in the EU, currently under review
- Biocon and Mylan are commercializing trastuzumab and Insulin Glargine in the EU while commercialization of biosimilar pegfilgrastim is imminent. Additionally, the company expanded its production capacity for pegfilgrastim DS and trastuzumab DP through the new B-4 and B-2 manufacturing facility, which received US FDA's approval in Nov 2019 and Oct 2019 respectively
8. Fresenius Kabi Reports EMA's Acceptance of MAA for its MSB11455 (biosimilar, pegfilgrastim)
Date: May 25, 2020
Product: MSB11455 (biosimilar, pegfilgrastim)
- The MAA submission of the MSB11455 includes the results of two pivotal clinical trials including bioequivalent PK & PD data with similar immunogenicity results and includes analytical plus safety data which was comparable to pegfilgrastim
- Fresenius Kabi's attempt to submit MAA is another milestone following last year's approval and launch of the company's adalimumab biosimilar in EU and plans for the expansion of therapies in oncology and life-threatening diseases
- MSB11455 is recombinant human GCSF which helps in stimulation of white blood cell and is developed by Fresenius Kabi's biosimilars team based in Switzerland. Neulasta is a reference product approved for the reduction in the duration of neutropenia and the incidence of febrile neutropenia in adult patients treated with cytotoxic chemotherapy for malignancy in the EU
9. Daewon Pharmaceutical Launches its Terrosa (biosimilar, teriparatide) to Treat Osteoporosis
Date: May 26, 2020
Product: Terrosa (biosimilar, teriparatide)
- Terrosa is a parathyroid hormone (PTH) gene recombination candidate originally developed by Richter-Helm Biotec to treat osteoporosis in men and postmenopausal women including those at high risk of fracture. Additionally, Terrosa has completed its P-I and P-III trials in EU and Japan has shown an increase in bone density in the spine, femur, and hip joint
- The 4-year post marketing surveillance study is conducted as the drug is listed in equivalent biologic treatment to the reference product. The launch was successful as the patent for "stable teriparatide solution" and "increasing bone toughness and rigidity and fracture reduction method" expired in Dec 2018 and Aug 2019 respectively
- In 2017, EMA approved Terrosa and was launched in EU and the US but not as biosimilar in Aug 2019 in 2019 respectively
10. Celltrion Launches its Third Biosimilar Truxima (biosimilar, rituximab) in Brazil
Date: May 27, 2020
Product: Truxima (biosimilar, rituximab)
- In Jun 2021, the company plans for the closure of supplying Truxima to the state governments and will focus on expanding its footprints with exclusively selling it in Brazil. Truxima's safety and efficacy is proven as its prescriptions is expanded in the US, EU, and WW
- Additionally, on May 26th, 2020, Celltrion will launch Truxima Launching Symposium for Key Opinion Leader (KOL) medical personnel in Sao Paulo, Brazil coinciding it with the launch of Truxima and the event involved 500+ medical personnel focusing on COVID-19
- Truxima is a mAb approved by the US FDA and EMA and released in Latin America will affect impact on neighboring countries including Chile and Ecuador
Date: May 27, 2020
Products: Pembrolizumab (IV, 200mg), Herzuma (biosimilar, trastuzumab)
- The P-I/II study involve assessing of pembrolizumab (IV, 200mg), Herzuma (biosimilar trastuzumab) (6mg/kg (after 8mg/kg load) D1 and CT in 43 patients with median follow up of 18 mons. In patients with HER2-positive advanced gastric cancer (AGC)
- P-I/II study results: tumor shrinkage of 95.3%, ORR of 76.7%, CR 16.3%, PR 60.5%, disease control rate (DCR) of 97.7%, mPFS 8.6 mos., mOS 19.3 mos., mDOR 10.8 mos. and safety
- Herzuma (biosimilar trastuzumab) is a mAb targeted to bind selectively to the extracellular domain of an antigen called HER2 developed to treat adult patients with early breast cancer, metastatic breast cancer, and metastatic gastric cancer approved in Feb 2018 by EMA
12. Fresenius Kabi Reports the US FDA's Acceptance of BLA for MSB11455 (biosimilar, pegfilgrastim)
Date: May 28, 2020
Product: MSB11455 (biosimilar, pegfilgrastim)
- The BLA submission is based on analytical, PK/ PD, safety, and immunogenicity data from two clinical studies that demonstrated equivalent PK/ PD profile to Neulasta, similar immunogenicity & comparable safety profile in healthy volunteers
- The BLA represents Fresenius Kabi's first biosimilar candidate submitted to the FDA. Additionally, Fresenius Kabi also received EMA's acceptance for review MAA of MSB11455 on May 22, 2020
- MSB11455 is a biosimilar referencing Amgen's Neulasta, acts by stimulating the growth of WBCs. Neulasta is indicated to decrease the incidence of infection, as manifested by febrile neutropenia, in patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with febrile neutropenia in the US
13. Mycenax Signs an Agreement with Gedeon Richter for LusiNEX
Date: May 28, 2020
Product: LusiNEX (biosimilar of Actemra/ RoActemra)
- Mycenax to sell LusiNEX project, including cell banks, CMC technology, intellectual properties, and clinical trial results to Gedeon Richter making a total deal value $16.5M. Mycenax to get payments as it completes the stages of asset transfer which will be utilized to operation and facility expansion which further strengthen Mycenax's capacities in CDMO business
- The focus of the agreement is to fully focus on its CDMO business and become one of the CDMO companies in Asia
- LusiNEX is a biosimilar product of Actemra/ RoActemra and has completed its P-I demonstrating bioequivalence in 2018 and is expected to enter in P-III trial while further receiving market approval
Date: May 29, 2020
Product: Idacio (adalimumab, biosimilar)
- Fresenius Kabi and Medec collaborated to offer Idacio as an additional therapy option for rheumatologists and dermatologists to treat rheumatic illnesses. From Jun 01, 2020, Medec's will market the biosimilar therapy
- Last year, Fresenius Kabi launched Idacio in the EU for arthritis and psoriasis. The collaboration offers patients and doctors new benefits and synergies in therapy offerings as well as consulting
- Medac provides methotrexate (metex PEN, metex FS) as the parenteral treatment of patients with chronic inflammatory diseases, the affected patients are treated with a combination of methotrexate and adalimumab
Related Post: Insights+ Key Biosimilars Events of April 2020
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