Insights+ Key Biosimilars Events of March 2022

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Insights+ Key Biosimilars Events of March 2022

  • 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
  • During the month of March, Junshi & Mabwell Bioscience’s Junmaikang (biosimilar, adalimumab) received the NMPA’s approval for the treatment of RA & two other indication, The US FDA offered $5M funding for biosimilar regulatory science pilot program. Our team at PharmaShots has summarized 11 key events of the biosimilar space of March 2022

Biocon to Acquire Viatris’ Biosimilars Assets for ~$3.335B

Published: Mar 01, 2022

Product: N/A

  • Viatris to receive ~$3.335B including $2B in cash & ~$335M as additional fees expected to be paid in 2024, $1B of CCPS equivalent to an equity stake of 12.9%. The transaction is expected to be close in H2’22
  • The acquisition provides BBL full ownership of Viatris’ rights in biosimilars assets to recognize combined revenues & profits. BBL will gain access to a portfolio of biosimilars in insulin, oncology & immunology along with multiple other biosimilar assets
  • Viatris will provide commercial & transition services to BBL for 2yrs. Biocon will also gain access to Viatris’ global biosimilars business whose revenues are estimated at $1B in 2023 along with in-licensed biosimilar assets

The US FDA Offers $5M Funding for Biosimilar Regulatory Science Pilot Program

Published: Mar 07, 2022

Product: N/A

  • The US FDA has provided $5M funding for multiple research proposals under the upcoming BsUFA III regulatory science pilot program which will run from 2023 to 2027
  • The program aims is to advance the development of interchangeable products and to make biosimilar development more efficient. Additionally, ~$1M/award per year is available for projects to address the significant issues with the development of biosimilars or interchangeable.
  • The US FDA will review the applications from May 2022, while the research projects are expected to start from Sept 2022

Junshi & Mabwell Bioscience’s Junmaikang (biosimilar, adalimumab) Receive the NMPA’s Approval for the Treatment of RA & Two Other Indication

Published: Mar 08, 2022

Product: Junmaikang (biosimilar, adalimumab)

  • The NMPA has approved adalimumab biosimilar Junmaikang for the marketing authorization to treat RA, AS, Psoriasis. The therapy is being jointly developed by both companies
  • Additionally, the therapy has received Major Scientific and Technological Support from the National 12th 5yr. plan for major new drug creation science and technology
  • Adalimumab has sold under the brand name Humira & was used to treat RA, PsA, AS, CD, UC, Psoriasis, HS, uveitis & JIA

Alvotech Entered into a Settlement Agreement with AbbVie for AVT02 (biosimilar, adalimumab)

Published: Mar 08, 2022

Product: AVT02 (biosimilar, adalimumab)

  • Alvotech gets the non-exclusive rights to market AVT02 (100mg/mL) high-concentration, citrate-free biosimilar candidate for Humira (adalimumab) in the US with an expected date of launch on July 1, 2023
  • Additionally, all ongoing US disputes b/w AbbVie & Alvotech have been resolved related to adalimumab biosimilar, including the ITC case that was filed in Dec. 2021. The agreement removes any corresponding litigation-related barriers from reaching US patients with rheumatic conditions
  • AVT02 has been approved in the EU, Canada & the UK. On Dec 7, 2021, Alvotech and Oaktree had entered into a definitive business combination agreement where the combined company’s securities are listed on NASDAQ under the symbol “ALVO”

Samsung Bioepis and Biogen’s Byooviz (biosimilar, ranibizumab) Receive the Health Canada Approval for the Treatment of Retinal Vascular Disorders

Published: Mar 11, 2022

Product: Byooviz (biosimilar, ranibizumab)

  • Health Canada has approved Byooviz biosimilar referencing Lucentis for wet AMD, visual impairment due to DME, macular edema secondary to RVO, CNV secondary to PM,  CNV secondary to ocular conditions
  • The approval was based on a totality of evidence including quality, non-clinical/clinical data from the P-III study to evaluate the efficacy, safety, PK & immunogenicity of ranibizumab vs Lucentis in patients with wet AMD. The results were found to be similar
  • Byooviz marks 1st Lucentis biosimilar to be approved in Canada & 1st ophthalmology biosimilar approved in the US. In Nov’19, Samsung Bioepis & Biogen had entered into a commercialization agreement for 2 ophthalmology biosimilar i.e., SB11 & SB15

Celltrion Reports Results of CT-P39 (biosimilar, omalizumab) in P-I Study for Asthma and Chronic Idiopathic Urticaria

Published: Mar 15, 2022

Product: CT-P39 (biosimilar, omalizumab)

  • The company reported the results from the P-I study to evaluates omalizumab biosimilar CT-P39 vs Genentech’ Xolair in 176 healthy patients aged b/w 18 & 55yrs. with asthma & CIU. The therapy was given as 150mg dose of CT-P39, EU & US-Xolair
  • The results showed similar safety & PK profiles to Xolair, 62 patients received biosimilar, 64 received the EU-Xolair & 50 US-Xolair, mean serum concentrations were similar b/w the treatment groups
  • The company has launched omalizumab biosimilar Genolar in Russia in Feb 2022 for persistent atopic bronchial asthma & resistant CIU aged ≥6yrs. under the agreement b/w selexis & generium. Omalizumab is an anti-inflammatory agent that binds to free IgE resulting in a reduction of free IgE & increase in total IgE

OcyonBio Partner Biosimilar Solutions Reports the Initiation of Registrational Clinical Trials for Biosimilar BSC1020 to Treat Cancer

Published: Mar 23, 2022

Product: BSC1020

  • The company initiates the registrational clinical trials to evaluate the biosimilarity of BSC1020 vs Neupogen in patients with cancer. The trial is expected to complete in July 2022
  • Neupogen has been manufactured at Amgen's Biologics facility in Puerto Rico while the trial is designed to identify the similarity b/w biosimilar and Neupogen
  • The company has entered into a manufacturing and operations agreement with OcyonBio & has plans to complete a technology transfer to initiate manufacturing in Puerto Rico in 2022. The company will use its multiple assets for the research, development, and manufacture of biosimilar therapies

Celltrion Healthcare to Supply Remsima to the Brazilian Federal Government

Published: Mar 24, 2022

Product: Remsima

  • Celltrion’s biosimilar Remsima has won a tender by the Brazilian Federal Government along with 12 state bids to supply Remsima including in Sao Paulo, following the Aug 2021 agreement with the Ministry of Health for 2 anticancer drugs, Herzuma & Truxima
  • The company also won a tender offer by INSABI for the purchase of Truxima for 1yr. & will supply Remsima to private sector, federal & State government
  • The company broadens patient access to effective & affordable biosimilar therapy in Brazil & Mexico, strengthening & expand its presence in Latin America. The company also established an entity in Brazil & Mexico to manage sales & marketing activities for biosimilar products

Prestige BioPharma Published Results of HD201 (biosimilar, trastuzumab) for the Treatment of ERBB2+ Breast Cancer in JAMA Oncology

Published: Mar 24, 2022

Product: HD201 (biosimilar, trastuzumab)

  • The P-III (TROIKA) study evaluates the efficacy and safety of patients who received HD201 vs Herceptin in 502 patients with ERBB2+ breast cancer across 70 centers in 12 countries & completed the median follow-up period of 31mos. Additionally, 251 were randomized to receive the biosimilar, and 252 were assigned to receive the reference product
  • The results showed that tpCR rates (45.0% vs 48.7%) & demonstrated an equivalant efficacy & safety profiles, 2232 treatment-related AEs were reported in 433 patients (86.1%), 220 were in the biosimilar group (88.0%) & 213 in Herceptin. (84.5%)
  • Additionally, serious treatment-related AEs were reported in 24 vs 17 patients, treatment discontinuation in 16 vs 12 patients. Since June 2019, EMA has been reviewing Prestige Biopharma’s MAA application for HD201

British Columbia Secures Reimbursement of Three New Biosimilars for the Prevention of Blood Clot

Published: Mar 24, 2022

Product: N/A

  • British Columbia’s Ministry of Health has reported the 3 new enoxaparin biosimilars i.e., Redesca was developed by Valero, Noromby by Juno & Inclunox by Sandoz for the prevention of blood clot disorders
  • The 3 biosimilars secured public reimbursement status in British Columbia covered by PharmaCare which was the province’s public health plan while enoxaparin has been delisted. Additionally, both the original & high-potency versions of the products are available for public reimbursement
  • British Columbia has adopted its policy in Nov 2019 & moved into the third phase of the program in Aug 2020 including 3 rituximab biosimilars in its options list for patients  switched from Rituxan

Lannett Reports the First Patient Dosing in the Pivotal Clinical Trial of Biosimilar Insulin Glargine

Published: Mar 29, 2022

Product: Biosimilar Insulin Glargine

  • The first patient has been dosed in the pivotal clinical trial of biosimilar insulin glargine across South Africa. The biosimilar is being co-developed with its strategic alliance partners within HEC & the results are expected at the end of 2022
  • The first study was reviewed by the US FDA which recommended that the Lannett/HEC insulin glargine product would be biosimilar to Sanofi’s Lantus by meeting the PK & PD EPs of the trial. Additionally, clinical material manufactured at a commercial scale in a new insulin facility will be used for the pivotal trial
  • If successful, the company will file the BLA in early 2023 & the product is expected to be launched in H1’24, if approved

Related Post: Insights+ Key Biosimilars Events of February 2022

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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