FDA Approves Faricimab Vabysmo A Bispecific Antibody To Treat Retinal Disease

The recent development of bispecific antibodies represents breakthrough therapy in the management of wide range of chronic multifactorial diseases. Bispecific antibodies are dual targeting modalities which can simultaneously combine two epitopes. Since their introduction into the market scientists are constantly exploring the sector of bispecific antibodies. Their multifactorial approach in the management of diseases and their ability to pass through the blood brain barrier is gaining the interest of various researchers.

Recently in January, 2022 US FDA has granted approval to Roche’s Vabsymo (Faricimab) for the treatment of wet, or neovascular, age-related macular degeneration (AMD) and diabetic macular edema (DME). Vabsymo is novel humanized bispecific antibody which works by inhibiting the angiopoietin-2 (Ang-2) and vascular endothelial growth factor-A (VEGF-A) pathways. Blocking both pathways is expected to stabilize blood vessels and potentially improve vision outcomes in patients with retinal conditions. The rapid approval of the drug is based on the promising results of Phase-III clinical trial that demonstrated Vabysmo given at intervals of up to four months achieved non-inferior vision gains versus aflibercept given every two months in the first year.  

Global Bispecific Antibody Market Insight 2028 Report Highlights:

  • Research Methodology
  • Global and Regional Market Analysis
  • Global Bispecific Antibody Market Opportunity Assessment: > USD 20 Billion
  • Market Sales Insight 2020 Till 2028
  • Approved Drug Sales Insight Till Dec 2021(Updated Every Quarter)
  • Approved Drug Sales Forecast Till 2028
  • Approved Drug In Market: 4 Drugs
  • Approved Bispecific Antibody Drug Patent, Price and Sales insight 2020 Till 2028
  • Future Market Assessment By Indication Till 2028
  • Ongoing Clinical Trials Assessment by Status, Phase and Region
  • Key Market Dynamics
  • Competitor Landscape

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The entry of Vabysmo in the global market will show high adoption rates as Vabysmo is the first and only FDA-approved injectable eye medicine for wet AMD and DME that improves and maintains vision with treatments from one to four months apart in the first year following four initial monthly doses. Currently, the drug is only approved in US whereas the European Medicines Agency is also currently evaluating the Vabysmo Marketing Authorization Application to treat wet AMD and DME. The drug is expected to gain approval in other regions during the forthcoming years which will further drive the growth of market.

Apart from this, three other bispecific antibodies are also present in market including Blincyto, Hemlibra, and Rybrevant. These drugs have shown high adoption rates due to their dual binding efficacy and ability to overcome the limitations of already approved therapies. In addition to this, the pipeline of bispecific antibody is highly crowded and consists of several drugs which are present in late stage of development and are awaiting regulatory approval. Recently in 2022, Janssen Pharmaceutical has submitted marketing authorization application to EMA as well as US FDA seeking approval of teclistamab for the treatment of patients with relapsed or refractory multiple myeloma (RRMM).     

Research and development activities have a vital role in improving the growth structure of the bispecific antibody therapeutics market. The players indulge in these activities for deriving new formulations and techniques that help in enhancing the overall growth trajectory. Further, mergers and acquisitions also form an important part of the growth landscape. For instance in 2021, Loxo Oncology and Merus announced a partnership to research and develop up to three CD3 engaging T-cell redirecting bispecific antibody therapies. The research collaboration and exclusive license agreement is set to leverage Merus’ proprietary Biclonics platform along with the drug design expertise of the Lilly division. In addition, Xencor and Janssen Pharmaceuticals to develop and commercialize plamotamab and novel XmAb® B-cell targeting bispecific antibodies that are designed to conditionally activate T cells through the CD28 co-stimulatory receptor.

As per our report findings, the global bispecific antibody market is expected to surpass US$ 20 Billion by 2028. Increasing prevalence of cancer and other chronic diseases, growing regulatory approvals and launch of therapies and increasing research collaborations for the development of robust drug pipeline are the major factors driving the growth of global bispecific antibodies market over the forecast period. The key players in global bispecific antibody market include Roche, Amgen, AbbVie, Celgene, Oncomed Pharmaceuticals, Novartis, Sanofi, Genmab, Merus, and several others.      


Neeraj Chawla

Kuick Research

Research Head



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