Insights+ Key Biosimilars Events of August 2020

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Insights+ Key Biosimilars Events of August 2020

  • Biosimilars are developed to be highly similar versions of approved biologics in terms of safety, purity, and potency
  • Mylan with its partner Lupin and Biocon launched Nepexto (biosimilar, etanercept) and Semglee (insulin glargine injection) in Germany & in the US, respectively. Additionally, Formycon and Bioeq planned to initiate P-III MAGELLAN-AMD Trial for its FYB203 (biosimilar, aflibercept)
  • Our team at PharmaShots has summarized 11 key events of the biosimilar space of Aug 2020

1. Teva and Alvotech Collaborated to Commercialize Five Biosimilar Candidates in the US

 Published: Aug 05, 2020

Products: Biosimilars

  • Alvotech will lead the development, registration, and supply of the biosimilars, while Teva will be exclusively commercializing the products in the US. Alvotech will receive upfront with subsequent milestone payments over the next several years
  • The companies will share the profit from the commercialization of the biosimilars. The collaboration leverages Teva's commercial presence and extensive infrastructure in the US along with Alvotech's experience and state-of-the-art biologics manufacturing
  • The collaboration will improve patient access for high-quality biosimilar medicines in the US

2. Samsung Bioepis Launches Ontruzant (trastuzumab, biosimilar) for Early and Metastatic HER2-Overexpressing Breast Cancer in Brazil

Published: Aug 11, 2020

Product: Ontruzant (trastuzumab, biosimilar)

  • The company launches its first oncology treatment Ontruzant (trastuzumab), a biosimilar referencing Herceptin in Brazil. The biosimilar has received ANVISA's approval for the treatment of metastatic HER2-overexpressing BC, early HER2-overexpressing BC, and advanced gastric cancer
  • Ontruzant is being supplied to SUS through a PDP b/w Samsung Bioepis & Bionovis and Bio-Manguinhos. This the second product to be launched in Brazil followed by Brenzys, both in partnership with local partners
  • Ontruzant is now available in six markets: Brazil, Australia, EU, the US, Ukraine, and Korea. The therapy has received EC's MAA in Nov'2017 and the US FDA's approval in Jan'2019

3. Henlius HLX02 Received the NMPA's Approval as the First Trastuzumab Biosimilar in China

Published: Aug 17, 2020

Product: HLX02 (biosimilar, trastuzumab)

  • On Aug 14, 2020, HLX02 (biosimilar, trastuzumab) received NMPA's approval to treat HER2+ early BC, HER2+ m-BC, and HER2+ m-gastric cancer. Additionally, On 27th July, HLX02 has received EC's approval under the brand name Zercepac
  • Henlius followed the NMPA and EMA's biosimilar guidelines and has taken multiple head-to-head comparisons b/w HLX02 and the reference, Herceptin
  • Analytical studies, preclinical studies, P-I study, and a P-III study showed that HLX02 is highly similar to the reference in terms of quality, safety, and efficacy. Additionally, HLX01 (biosimilar, rituximab) received NMPA's approval in 2019

4. Celltrion Planned to Initiate P-I Trial for its CT-P41 (biosimilar, denosumab) in September 2020

Published: Aug 14, 2020

Product: CT-P41 (biosimilar, denosumab)

  • In H1'21, Celltrion plans to initiate P-III trial for CT-P41 and is expected to commercialize in Feb 2025 when Amgen's patents for Prolia expire in the US
  • Celltrion is also planning for the onset of P-III for CT-P16 in H1'21 targeted for metastatic colorectal cancer, metastatic breast cancer, and non small cell lung cancer. Additionally, one of its biosimilar CT-P39 is currently evaluated in P-I trial with expected P-III trial initiation in 2022
  • CT-P41 is a mAb a biosimilar to Amgen Prolia (denosumab) targets receptor activator of nuclear factor-kappa-ligand (RANKL) proteins in patients with osteoporosis

5. Sandoz Canada Negotiated with Pan-Canadian Pharmaceutical Alliance (pCPA) to Launch Ziextenzo (biosimilar, pegfilgrastim) and Riximyo (biosimilar, rituximab) in Canada

Published: Aug 19, 2020

Product: Ziextenzo (biosimilar, pegfilgrastim), Riximyo (biosimilar, rituximab)

  • In Jul 2020, following the pCPA agreement Riximyo is now reimbursed through Limited Use as well as the Exceptional Access Program while funding will be done by Cancer Care Ontario. Additionally, from Aug 01, 2020, the BC cancer will be responsible for reimbursement of Riximyo as per British Columbia
  • The patient support program will be initiated to provide patients the guidance with reimbursement navigation, financial assistance, administrative support, as well as education for patients
  • On Apr 28, 2020, Riximyo received HC approval a mAb or the treatment of NHL and CLL, as well as the autoimmune disease RA. On Apr 21, 2020, Ziextenzo received HC approval a long-acting form of recombinant human granulocyte colony-stimulating factor (r-metHuG-CSF) for to decrease the incidence of infection, as manifested by febrile neutropenia, in patients with non-myeloid malignancies receiving myelosuppressive antineoplastic agents

6. Samsung Bioepis Aybintio (SB8, biosimilar, bevacizumab) Received the EC's Approval for Launch in EU

Published: Aug 21, 2020

Product: Aybintio (SB8, biosimilar, bevacizumab)

  • The EMA's CHMP positive opinion was provided in June and is the fifth product which received the EU approval for autoimmune diseases and tumor diseases
  • The P-III study results of Abincio which involves 763 patients non-small cell lung cancer (NSCLC) patients and demonstrated the risk ratio of ORR vs original product, also presented at ESMO 2019
  •  Aybintio is a mAb targeted for metastatic carcinoma of the colon or rectum, metastatic breast cancer, non small cell lung cancer, advanced or metastatic renal cell cancer, epithelial ovarian, fallopian tube and primary peritoneal cancer, and cervical cancer. In Nov 20019, the approval review of BLA is submitted to the US FDA and is also accepted

7. Formycon with its Partner BIOEQ Planned to Initiate P-III MAGELLAN-AMD Trial for its FYB203 (biosimilar, aflibercept)

Published: Aug 24, 2020

Product: FYB203 (biosimilar, aflibercept)

  • BIOEQ to sponsor the P-III study which will assess the FYB203 vs Eylea in patients with neovascular age-related macular degeneration (nAMD) to evaluate its efficacy, safety, and immunogenicity. Additionally, the design of the study is developed in collaboration with the USFDA, EMA, PMDA
  • The second program in ophthalmology will aim to strengthen and expand the footprints in ophthalmologic biosimilars
  • FYB203 is a biosimilar to Eylea (aflibercept) human fusion protein works by binding to VEGF-A, targeted for neovascular age-related macular degeneration (nAMD) including serious eye diseases. In 2015, Formycon AG signed an exclusive global license agreement with Santo Holding (Deutschland) GmbH for FYB203

8. BeiGene Signed a License and Supply Agreement with Bio-Thera for BAT1706 (biosimilar, bevacizumab) in China

Published: Aug 24, 2020

Product: BAT1706 (biosimilar,bevacizumab)

  • Bio-Thera received $165M upfront, regulatory, and commercial milestones and is eligible to receive royalties on sales of the product. BeiGene to get the right to develop, manufacture, and commercialize BAT1706 in China, including Hong Kong, Macau, and Taiwan while Bio-Thera will retain rights for the therapy outside the licensed territory
  • The NMPA has recently accepted the BLA for BAT1706. The collaboration allows Bio-Thera to leverage BeiGene's expertise to accelerate the development and commercialization of BAT1706 as a single agent regimen or as a component of combinational therapies
  • BAT1706 is a mAb, a biosimilar referencing Avastin which is a treatment option for solid tumor indications in China such as colorectal, lung, and liver cancers. Additionally, Bio-Thera plans to file for the approval of BAT1706 in the US and EU in the Q4'20

9. Lupin and Mylan Launch Nepexto (biosimilar, etanercept) in Germany

Published: Aug 27, 2020

Product: Nepexto (biosimilar, etanercept)

  • The companies launch Nepexto, a biosimilar referencing Amgen's Enbrel, and is indicated for the moderate to severe RA, JIA from the age of 2yrs., active and progressive PsA, severe axSpA, moderate to severe PsO, and chronic severe PsO in children and adolescents from the age of 6yrs.
  • Nepexto is available as a solution for injection in a pre-filled pen and prefilled syringe and has shown equivalent efficacy and safety to Enbrel
  • The EC has approved MAA to Nepexto on Jun 04, 2020, following CHMP's positive opinion. The approval underlines the scientific success of Mylan's biologics program and expands Mylan's therapeutic portfolio for immune-mediated diseases including RA

10. Cadila Launch its Cadalimab (biosimilar, adalimumab) in India

Published: Aug 28, 2020

Product: Cadalimab ((biosimilar, adalimumab)

  • Cadalimab will be available in 40mg/0.8ml as a pre-filled syringe and is targeted for the reduction in signs and symptoms of Rheumatoid Arthritis, Juvenile Idiopathic Arthritis, Ankylosing Spondylitis, Psoriatic Arthritis, and Psoriasis
  • Additionally, Cadila has launched 3 more biosimilar products Bevaro, Ritucad, and NuPTH in the last 2 months
  • Adalimumab is a mAb and a disease-modifying antirheumatic drug that works by inactivating tumor necrosis factor-alpha (TNFa) recommended in the treatment of many diseases. In Feb 2020, Cadila concluded and cleared USFDA inspection

11. Mylan and Biocon Launch Semglee (insulin glargine injection) as Vials and Pre-Filled Pen in the US

Published: Aug 31, 2020

Product: Semglee (insulin glargine injection)

  • The companies have launched Semglee (insulin glargine injection) in a vial and pre-filled pen at WAC of $147.98/ package of (5) 3ml pens and $98.65/ 10ml vial, representing the lowest WAC for any long-acting insulin glargine
  • The US FDA has approved Semglee for the same indications as to its reference product Sanofi's Lantus, thus expanding access for millions of patients living with diabetes
  • Additionally, Mylan has submitted all necessary documentation to the FDA, requesting the approval of Semglee as a biosimilar to Lantus under the 351(k) pathways. Semglee has received regulatory approval in 45+ countries and is the third FDA's approved product under the Mylan-Biocon collaboration

Related Post: Insights+ Key Biosimilars Events of July 2020

Senior Editor

This content piece was prepared by our former Senior Editor. She had expertise in life science research and was an avid reader. For any query reach out to us at connect@pharmashots.com

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